Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Hypoxemia Clinical Trial

Official title:

Comparative Study on the Effectiveness, Comfort and Compliance of High-flow Nasal Oxygen Therapy and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05784636
• Other study ID #: 2022039
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: June 6, 2024

Study information

• Verified date: November 2022
• Source: Qilu Hospital of Shandong University
• Contact: Dedong Ma, MD
• Phone: 18560082806
• Email: ma[@]qiluhuxi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. patients in group A were first treated with HFNC on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. patients in group B were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with HFNC until discharge. Patient information was collected during treatment.

Description:

Patients who met the inclusion criteria were included and signed the informed consent, which met the requirements of the ethics committee of our unit. All subjects were hospitalized patients. Subjects were randomly divided into two groups. Patients in group A were treated with HFNC on the basis of conventional treatment. The initial parameters were: temperature:31-37℃, flow: 30-40l /min, SpO2 > 92% maintained, the oxygen concentration was adjusted according to the patient's oxygen saturation, and the treatment time was 24h. Twenty-four hours later, the patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. On the basis of conventional treatment, patients in group B were given a non-invasive ventilator with the following initial parameters: BiPaP mode, initial inspiratory pressure (IPAP) of 8-15cmH2O, initial expiratory pressure (EPAP) of 4-8cmH2O. The parameters were adjusted according to the specific conditions of the patients. After 24 hours of treatment, the patient was treated with HFNC until discharge. Patient information was collected during treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 243
• Est. completion date: June 6, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. . PaO2 < 60mmHg, SpO2 < 92%(without oxygen inhalation);

2. Mild to moderate type I respiratory failure (100 mmHg < PaO/Fi02=300 mmHg);

Exclusion Criteria:

1. Missing primary outcome measures

2. Terminal stage of various chronic diseases;

3. The patient or family members do not agree to NIV or HFNI treatment;

4. Severe type I respiratory failure (PaO2/Fi02=100 mmHg)

5. Ventilation dysfunction (pH<7.30)

6. Contradictory breathing

7. The patient abandons or terminates treatment, automatically discharges or transfers to another hospital;

8. Serious diseases, such as organ function damage and sepsis;

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Device:
• Non-invasive BiPAP ventilation
Patients were first treated with HFNC (High-flow nasal cannula) on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40l /min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge.
• HFNC
On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC (High-flow nasal cannula) until discharge.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (3)

Chen BX, Ou Q, Pan MX. [A cross-sectional survey of treatment acceptance and influence factors in patients with obstructive sleep apnea]. Zhonghua Yi Xue Za Zhi. 2018 May 29;98(20):1578-1581. doi: 10.3760/cma.j.issn.0376-2491.2018.20.010. Chinese. — View Citation

Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3. — View Citation

Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HR	Heart rate	At the time of enrollment in the clinical study
Primary	HR	Heart rate	On the first hour after enrollment
Primary	HR	Heart rate	On the second hour after enrollment
Primary	HR	Heart rate	On the 6th hour after enrollment
Primary	HR	Heart rate	On the 12th hour after enrollment
Primary	HR	Heart rate	On the 24th hour after enrollment
Primary	HR	Heart rate	On the 25th hour after enrollment (On the first hour after crossover)
Primary	HR	Heart rate	On the 26th hour after enrollment (On the second hour after crossover)
Primary	HR	Heart rate	On the 30th hour after enrollment (On the 6th hour after crossover)
Primary	HR	Heart rate	On the 36th hour after enrollment (On the 12th hour after crossover)
Primary	HR	Heart rate	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	HR	Heart rate	On the third day after enrollment (On the 48th hour after crossover)
Primary	HR	Heart rate	On the 4th day after enrollment (On the third day after crossover)
Primary	HR	Heart rate	On the 5th day after enrollment (On the 4th day after crossover)
Primary	HR	Heart rate	On the 6th day after enrollment (On the 5th day after crossover)
Primary	HR	Heart rate	On the 7th day after enrollment (On the 6th day after crossover)
Primary	HR	Heart rate	On the 8th day after enrollment (On the 7th day after crossover)
Primary	HR	Heart rate	On the 9th day after enrollment (On the 8th day after crossover)
Primary	RR	Respiratory rate	At the time of enrollment in the clinical study
Primary	RR	Respiratory rate	On the first hour after enrollment
Primary	RR	Respiratory rate	On the second hour after enrollment
Primary	RR	Respiratory rate	On the 6th hour after enrollment
Primary	RR	Respiratory rate	On the 12th hour after enrollment
Primary	RR	Respiratory rate	On the 24th hour after enrollment
Primary	RR	Respiratory rate	On the 25th hour after enrollment (On the first hour after crossover)
Primary	RR	Respiratory rate	On the 26th hour after enrollment (On the second hour after crossover)
Primary	RR	Respiratory rate	On the 30th hour after enrollment (On the 6th hour after crossover)
Primary	RR	Respiratory rate	On the 36th hour after enrollment (On the 12th hour after crossover)
Primary	RR	Respiratory rate	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	RR	Respiratory rate	On the third day after enrollment (On the 48th hour after crossover)
Primary	RR	Respiratory rate	On the 4th day after enrollment (On the third day after crossover)
Primary	RR	Respiratory rate	On the 5th day after enrollment (On the 4th day after crossover)
Primary	RR	Respiratory rate	On the 6th day after enrollment (On the 5th day after crossover)
Primary	RR	Respiratory rate	On the 7th day after enrollment (On the 6th day after crossover)
Primary	RR	Respiratory rate	On the 8th day after enrollment (On the 7th day after crossover)
Primary	RR	Respiratory rate	On the 9th day after enrollment (On the 8th day after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	At the time of enrollment in the clinical study
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the first hour after enrollment
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the second hour after enrollment
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 6th hour after enrollment
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 12th hour after enrollment
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 24th hour after enrollment
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 25th hour after enrollment (On the first hour after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 26th hour after enrollment (On the second hour after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 30th hour after enrollment (On the 6th hour after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 36th hour after enrollment (On the 12th hour after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the third day after enrollment (On the 48th hour after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 4th day after enrollment (On the third day after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 5th day after enrollment (On the 4th day after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 6th day after enrollment (On the 5th day after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 7th day after enrollment (On the 6th day after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 8th day after enrollment (On the 7th day after crossover)
Primary	BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 9th day after enrollment (On the 8th day after crossover)
Primary	SO2	Pulse oxygen saturation	At the time of enrollment in the clinical study
Primary	SO2	Pulse oxygen saturation	On the first hour after enrollment
Primary	SO2	Pulse oxygen saturation	On the second hour after enrollment
Primary	SO2	Pulse oxygen saturation	On the 6th hour after enrollment
Primary	SO2	Pulse oxygen saturation	On the 12th hour after enrollment
Primary	SO2	Pulse oxygen saturation	On the 24th hour after enrollment
Primary	SO2	Pulse oxygen saturation	On the 25th hour after enrollment (On the first hour after crossover)
Primary	SO2	Pulse oxygen saturation	On the 26th hour after enrollment (On the second hour after crossover)
Primary	SO2	Pulse oxygen saturation	On the 30th hour after enrollment (On the 6th hour after crossover)
Primary	SO2	Pulse oxygen saturation	On the 36th hour after enrollment (On the 12th hour after crossover)
Primary	SO2	Pulse oxygen saturation	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	SO2	Pulse oxygen saturation	On the third day after enrollment (On the 48th hour after crossover)
Primary	SO2	Pulse oxygen saturation	On the 4th day after enrollment (On the third day after crossover)
Primary	SO2	Pulse oxygen saturation	On the 5th day after enrollment (On the 4th day after crossover)
Primary	SO2	Pulse oxygen saturation	On the 6th day after enrollment (On the 5th day after crossover)
Primary	SO2	Pulse oxygen saturation	On the 7th day after enrollment (On the 6th day after crossover)
Primary	SO2	Pulse oxygen saturation	On the 8th day after enrollment (On the 7th day after crossover)
Primary	SO2	Pulse oxygen saturation	On the 9th day after enrollment (On the 8th day after crossover)
Primary	pH	Degree of pH in arterial blood	At the time of enrollment in the clinical study
Primary	pH	Degree of pH in arterial blood	On the 24th hour after enrollment
Primary	pH	Degree of pH in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	pH	Degree of pH in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	pH	Degree of pH in arterial blood	On the 4th day after enrollment (On the 3th day after crossover)
Primary	pH	Degree of pH in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	pH	Degree of pH in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	pH	Degree of pH in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	pH	Degree of pH in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	pH	Degree of pH in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	PaO2	Partial arterial oxygen pressure	At the time of enrollment in the clinical study
Primary	PaO2	Partial arterial oxygen pressure	On the 24th hour after enrollment
Primary	PaO2	Partial arterial oxygen pressure	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	PaO2	Partial arterial oxygen pressure	On the third day after enrollment (On the 48th hour after crossover)
Primary	PaO2	Partial arterial oxygen pressure	On the 4th day after enrollment (On the 3th day after crossover)
Primary	PaO2	Partial arterial oxygen pressure	On the 5th day after enrollment (On the 4th day after crossover)
Primary	PaO2	Partial arterial oxygen pressure	On the 6th day after enrollment (On the 5th day after crossover)
Primary	PaO2	Partial arterial oxygen pressure	On the 7th day after enrollment (On the 6th day after crossover)
Primary	PaO2	Partial arterial oxygen pressure	On the 8th day after enrollment (On the 7th day after crossover)
Primary	PaO2	Partial arterial oxygen pressure	On the 9th day after enrollment (On the 8th day after crossover)
Primary	SaO2	Arterial oxygen saturation	At the time of enrollment in the clinical study
Primary	SaO2	Arterial oxygen saturation	On the 24th hour after enrollment
Primary	SaO2	Arterial oxygen saturation	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	SaO2	Arterial oxygen saturation	On the third day after enrollment (On the 48th hour after crossover)
Primary	SaO2	Arterial oxygen saturation	On the 4th day after enrollment (On the third day after crossover)
Primary	SaO2	Arterial oxygen saturation	On the 5th day after enrollment (On the 4th day after crossover)
Primary	SaO2	Arterial oxygen saturation	On the 6th day after enrollment (On the 5th day after crossover)
Primary	SaO2	Arterial oxygen saturation	On the 7th day after enrollment (On the 6th day after crossover)
Primary	SaO2	Arterial oxygen saturation	On the 8th day after enrollment (On the 7th day after crossover)
Primary	SaO2	Arterial oxygen saturation	On the 9th day after enrollment (On the 8th day after crossover)
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	At the time of enrollment in the clinical study
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the 24th hour after enrollment
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	PCO2	partial pressure of carbon dioxide in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	FiO2	Fraction of inspiration O2	At the time of enrollment in the clinical study
Primary	FiO2	Fraction of inspiration O2	On the 24th hour after enrollment
Primary	FiO2	Fraction of inspiration O2	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	FiO2	Fraction of inspiration O2	On the third day after enrollment (On the 48th hour after crossover)
Primary	FiO2	Fraction of inspiration O2	On the 4th day after enrollment (On the third day after crossover)
Primary	FiO2	Fraction of inspiration O2	On the 5th day after enrollment (On the 4th day after crossover)
Primary	FiO2	Fraction of inspiration O2	On the 6th day after enrollment (On the 5th day after crossover)
Primary	FiO2	Fraction of inspiration O2	On the 7th day after enrollment (On the 6th day after crossover)
Primary	FiO2	Fraction of inspiration O2	On the 8th day after enrollment (On the 7th day after crossover)
Primary	FiO2	Fraction of inspiration O2	On the 9th day after enrollment (On the 8th day after crossover)
Primary	Lac	Lactic acid in arterial blood	At the time of enrollment in the clinical study
Primary	Lac	Lactic acid in arterial blood	On the 24th hour after enrollment
Primary	Lac	Lactic acid in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	Lac	Lactic acid in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	Lac	Lactic acid in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Primary	Lac	Lactic acid in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	Lac	Lactic acid in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	Lac	Lactic acid in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	Lac	Lactic acid in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	Lac	Lactic acid in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	Glu	Arterial blood glucose in arterial blood	At the time of enrollment in the clinical study
Primary	Glu	Arterial blood glucose in arterial blood	On the 24th hour after enrollment
Primary	Glu	Arterial blood glucose in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	Glu	Arterial blood glucose in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	GLu	Arterial blood glucose in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Primary	Glu	Arterial blood glucose in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	Glu	Arterial blood glucose in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	Glu	Arterial blood glucose in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	Glu	Arterial blood glucose in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	Glu	Arterial blood glucose in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	At the time of enrollment in the clinical study
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 24th hour after enrollment
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 4th day after enrollment (On the third day after crossover)
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	BE	Base excess in arterial blood	At the time of enrollment in the clinical study
Primary	BE	Base excess in arterial blood	On the 24th hour after enrollment
Primary	BE	Base excess in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	BE	Base excess in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	BE	Base excess in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Primary	BE	Base excess in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	BE	Base excess in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	BE	Base excess in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	BE	Base excess in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	BE	Base excess in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	RI	Respiratory Index	At the time of enrollment in the clinical study
Primary	RI	Respiratory Index	On the 24th hour after enrollment
Primary	RI	Respiratory Index	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	RI	Respiratory Index	On the third day after enrollment (On the 48th hour after crossover)
Primary	RI	Respiratory Index	On the 4th day after enrollment (On the third day after crossover)
Primary	RI	Respiratory Index	On the 5th day after enrollment (On the 4th day after crossover)
Primary	RI	Respiratory Index	On the 6th day after enrollment (On the 5th day after crossover)
Primary	RI	Respiratory Index	On the 7th day after enrollment (On the 6th day after crossover)
Primary	RI	Respiratory Index	On the 8th day after enrollment (On the 7th day after crossover)
Primary	RI	Respiratory Index	On the 9th day after enrollment (On the 8th day after crossover)
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	At the time of enrollment in the clinical study
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the 24th hour after enrollment
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the third day after enrollment (On the 48th hour after crossover)
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the 4th day after enrollment (On the third day after crossover)
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the 5th day after enrollment (On the 4th day after crossover)
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the 6th day after enrollment (On the 5th day after crossover)
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the 7th day after enrollment (On the 6th day after crossover)
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the 8th day after enrollment (On the 7th day after crossover)
Primary	Arterial blood HCO3- concentration	Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration	On the 9th day after enrollment (On the 8th day after crossover)
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	At the time of enrollment in the clinical study
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the 24th hour after enrollment
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the third day after enrollment (On the 48th hour after crossover)
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the 4th day after enrollment (On the third day after crossover)
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the 5th day after enrollment (On the 4th day after crossover)
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the 6th day after enrollment (On the 5th day after crossover)
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the 7th day after enrollment (On the 6th day after crossover)
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the 8th day after enrollment (On the 7th day after crossover)
Primary	Arterial blood K+ concentration	Arterial blood K+ concentration	On the 9th day after enrollment (On the 8th day after crossover)
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	At the time of enrollment in the clinical study
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 24th hour after enrollment
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the third day after enrollment (On the 48th hour after crossover)
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 4th day after enrollment (On the third day after crossover)
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 5th day after enrollment (On the 4th day after crossover)
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 6th day after enrollment (On the 5th day after crossover)
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 7th day after enrollment (On the 6th day after crossover)
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 8th day after enrollment (On the 7th day after crossover)
Primary	Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 9th day after enrollment (On the 8th day after crossover)
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	At the time of enrollment in the clinical study
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 24th hour after enrollment
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the third day after enrollment (On the 48th hour after crossover)
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 4th day after enrollment (On the third day after crossover)
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 5th day after enrollment (On the 4th day after crossover)
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 6th day after enrollment (On the 5th day after crossover)
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 7th day after enrollment (On the 6th day after crossover)
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 8th day after enrollment (On the 7th day after crossover)
Primary	Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 9th day after enrollment (On the 8th day after crossover)
Primary	TCO2	Total carbon dioxide in arterial blood	At the time of enrollment in the clinical study
Primary	TCO2	Total carbon dioxide in arterial blood	On the 24th hour after enrollment
Primary	TCO2	Total carbon dioxide in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	TCO2	Total carbon dioxide in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	TCO2	Total carbon dioxide in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Primary	TCO2	Total carbon dioxide in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	TCO2	Total carbon dioxide in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	TCO2	Total carbon dioxide in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	TCO2	Total carbon dioxide in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	TCO2	Total carbon dioxide in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	HCT	hematocrit in arterial blood	At the time of enrollment in the clinical study
Primary	HCT	hematocrit in arterial blood	On the 24th hour after enrollment
Primary	HCT	hematocrit in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	HCT	hematocrit in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	HCT	hematocrit in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Primary	HCT	hematocrit in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	HCT	hematocrit in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	HCT	hematocrit in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	HCT	hematocrit in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	HCT	hematocrit in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	tHbc	Total hemoglobin in arterial blood	At the time of enrollment in the clinical study
Primary	tHbc	Total hemoglobin in arterial blood	On the 24th hour after enrollment
Primary	tHbc	Total hemoglobin in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	tHbc	Total hemoglobin in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Primary	tHbc	Total hemoglobin in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Primary	tHbc	Total hemoglobin in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Primary	tHbc	Total hemoglobin in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Primary	tHbc	Total hemoglobin in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Primary	tHbc	Total hemoglobin in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Primary	tHbc	Total hemoglobin in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Primary	height	m	At the time of enrollment in the clinical study
Primary	Weight	Kg	At the time of enrollment in the clinical study
Primary	gender	Male and female	At the time of enrollment in the clinical study
Primary	age	year	At the time of enrollment in the clinical study
Primary	WBC	The number of white blood cells in venous blood	On the first day after enrollment
Primary	WBC	The number of white blood cells in venous blood	up to 9 days
Primary	NEU	The number of Neutrophil granulocyte in venous blood	On the first day after enrollment
Primary	NEU	The number of Neutrophil granulocyte in venous blood	up to 9 days
Primary	LYM	The number of Venous blood lymphocytes in venous blood	On the first day after enrollment
Primary	LYM	The number of Venous blood lymphocytes in venous blood	up to 9 days
Primary	EOS	The number of Venous blood eosinophils in venous blood	On the first day after enrollment
Primary	EOS	The number of Venous blood eosinophils in venous blood	up to 9 days
Primary	BAS	The number of Venous blood Basophils in venous blood	On the first day after enrollment
Primary	BAS	The number of Venous blood Basophils in venous blood	up to 9 days
Primary	MON	The number of Venous blood Monocyte cell in venous blood	On the first day after enrollment
Primary	MON	The number of Venous blood Monocyte cell in venous blood	up to 9 days
Primary	RBC	The number of red blood cells in venous blood	On the first day after enrollment
Primary	RBC	The number of red blood cells in venous blood	up to 9 days
Primary	HGB	The number of haemoglobin in venous blood	On the first day after enrollment
Primary	HGB	The number of haemoglobin in venous blood	up to 9 days
Primary	HCT	hematocrit in venous blood	On the first day after enrollment
Primary	HCT	hematocrit in venous blood	up to 9 days
Primary	MCV	Mean Corpuscular Volume in venous blood	On the first day after enrollment
Primary	MCV	Mean Corpuscular Volume in venous blood	up to 9 days
Primary	MCH	Mean Corpuscular Haemoglobin Concentration in venous blood	On the first day after enrollment
Primary	MCH	Mean Corpuscular Haemoglobin Concentration in venous blood	up to 9 days
Primary	RDW	red blood cell distribution width in venous blood	On the first day after enrollment
Primary	RDW	red blood cell distribution width in venous blood	up to 9 days
Primary	PLT	platelet in venous blood	On the first day after enrollment
Primary	PLT	platelet in venous blood	up to 9 days
Primary	PDW	Platelet distributionwidth in venous blood	On the first day after enrollment
Primary	PDW	Platelet distributionwidth in venous blood	up to 9 days
Primary	MPV	Mean Platelet Volume in venous blood	On the first day after enrollment
Primary	MPV	Mean Platelet Volume in venous blood	up to 9 days
Primary	plateletcrit	plateletcrit in venous blood	On the first day after enrollment
Primary	plateletcrit	plateletcrit in venous blood	up to 9 days
Primary	CRP	C-reactive protein in venous blood	On the first day after enrollment
Primary	CRP	C-reactive protein in venous blood	up to 9 days
Primary	PCT	Procalcitonin in venous blood	On the first day after enrollment
Primary	PCT	Procalcitonin in venous blood	up to 9 days
Primary	NT-proBNP	NT-proBNP in venous blood	On the first day after enrollment
Primary	NT-proBNP	NT-proBNP in venous blood	up to 9 days
Primary	ESR	erythrocytesedimentationrate in venous blood	On the first day after enrollment
Primary	ESR	erythrocytesedimentationrate in venous blood	up to 9 days
Primary	PT	prothrombin time in venous blood	On the first day after enrollment
Primary	PT	prothrombin time in venous blood	up to 9 days
Primary	APTT	activated partial thromboplastin time in venous blood	On the first day after enrollment
Primary	APTT	activated partial thromboplastin time in venous blood	up to 9 days
Primary	TT	Thrombin time in venous blood	On the first day after enrollment
Primary	TT	Thrombin time in venous blood	up to 9 days
Primary	D-Di	D-Dimer in venous blood	On the first day after enrollment
Primary	D-Di	D-Dimer in venous blood	up to 9 days
Primary	ALT	alanine transaminase in venous blood	On the first day after enrollment
Primary	ALT	alanine transaminase in venous blood	up to 9 days
Primary	AST	Aspartate Transaminase in venous blood	On the first day after enrollment
Primary	AST	Aspartate Transaminase in venous blood	up to 9 days
Primary	PA	Serum prealbumin in venous blood	On the first day after enrollment
Primary	PA	Serum prealbumin in venous blood	up to 9 days
Primary	TP	Total serum protein in venous blood	On the first day after enrollment
Primary	TP	Total serum protein in venous blood	up to 9 days
Primary	ALB	Albumin protein in venous blood	On the first day after enrollment
Primary	ALB	Albumin protein in venous blood	up to 9 days
Primary	GLB	Globulin globulin in venous blood	On the first day after enrollment
Primary	GLB	Globulin globulin in venous blood	up to 9 days
Primary	Cr	creatinine in venous blood	On the first day after enrollment
Primary	Cr	creatinine in venous blood	up to 9 days
Primary	BUN	Urea nitrogen in venous blood	On the first day after enrollment
Primary	BUN	Urea nitrogen in venous blood	up to 9 days
Primary	Cys-C	Cystatin C in venous blood	On the first day after enrollment
Primary	Cys-C	Cystatin C in venous blood	up to 9 days
Primary	eGFR	Estimate glomerular filtration rate in venous blood	On the first day after enrollment
Primary	eGFR	Estimate glomerular filtration rate in venous blood	up to 9 days
Primary	Respiratory support time	Daily respiratory support time after patients were enrolled in the clinical study,h/Day	during hospitalization, approximately 9 days
Primary	Relief time for dyspnea	Remission time of dyspnea after intervention	during hospitalization, approximately 9 days
Primary	Tracheal intubation	Yes or No	during hospitalization, approximately 9 days
Primary	Stay in the ICU	Yes or No	during hospitalization, approximately 9 days
Primary	Complications	Facial injury, flatulence,Gastroesophageal reflux,Dry throat, sore throat,pneumothorax,Eye irritation discomfort,Low blood pressure.	during hospitalization, approximately 9 days
Primary	Outcome of disease	Get better, get worse, die	during hospitalization, approximately 9 days
Primary	Total bilirubin	Serum total bilirubin in venous blood	On the first day after enrollment
Primary	Total bilirubin	Serum total bilirubin in venous blood	up to 9 days
Primary	DBIL	Direct bilirubin in venous blood	On the first day after enrollment
Primary	DBIL	Direct bilirubin in venous blood	up to 9 days
Primary	IBIL	Indirect bilirubin in venous blood	On the first day after enrollment
Primary	IBIL	Indirect bilirubin in venous blood	up to 9 days
Primary	Diaphragm mobility	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.	At the time of enrollment in the clinical study
Primary	Diaphragm mobility	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.	On the 24th hour after enrollment
Primary	Diaphragm mobility	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	Diaphragm mobility	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.	up to 9 days
Primary	Diaphragm thickness	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.	At the time of enrollment in the clinical study
Primary	Diaphragm thickness	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.	On the 24th hour after enrollment
Primary	Diaphragm thickness	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.	On the 48th hour after enrollment (On the 24th hour after crossover)
Primary	Diaphragm thickness	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.	up to 9 days
Secondary	Patient compliance to the treatment	Patients were managed for compliance with the treatment.Dependent judgment; Complete dependence: patients actively cooperate with medical staff in treatment; Partial dependence: in most cases, patients can cooperate with the treatment, and in a few cases, patients resist the treatment but receive treatment after being enlightened by the medical staff.; Non-dependence: patients have strong resistance and resistance, so that they are unable to use ventilators or nasal high-flow humidification instruments.	during hospitalization, approximately 9 days
Secondary	Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort	Kolcaba's General Comfort Questionnaire (GCQ) is composed of 28 items from 4 dimensions: physiological, psychological, spiritual, socio-cultural and environmental. The modification Scale adopts 1 to 4Likert Scale, with 1 indicating strongly disagree and 4 indicating strongly agree. In the negative question, 1 means strongly agree and 4 means strongly disagree. A higher score indicates more comfort.	during hospitalization, approximately 9 days
Secondary	Dyspnea rating scale	According to the degree of dyspnea and symptoms of the patient, the lowest score is 0, the highest score is 10.	during hospitalization, approximately 9 days