High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure

Acute Respiratory Failure With Hypercapnia Clinical Trial

Official title:

High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03229460
• Other study ID #: XH-17-008
• Status: Recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: bin he
• Phone: 021-25077828
• Email: hebinicu[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy ang noninvasive ventilation.

Description:

Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hypoxemic and no hypercapnic acute respiratory failure :

• severe dyspnea at rest with a respiratory rate >25 breaths/min

• PaO2/FiO2 <300

• PaCO2 <45 mmHg,

Exclusion Criteria:

• age <18 years

• NPPV contraindications

• past history of respiratory chronic disease (COPD, cystic fibrosis…)

• cardiac pulmonary edema

• Pre-defined intubation

• other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score = 12)

• profound aplasia (white cells count <1000/mm 3)

Related Conditions & MeSH terms

• Acute Respiratory Failure With Hypercapnia
• Hypercapnia
• Hypoventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Other:
• standard low flow therapy
In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.

Device:
• high flow nasal oxygen therapy
The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%.
• association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2.

Locations

Country	Name	City	State
China	Ethics Committee of Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of patients in each group who require endotracheal intubation with mechanical ventilation	To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation	28days
Secondary	mechanical ventilation-free to day 28		28 days