The Noninvasive Ventilation to COVID-19 Patients

Noninvavie Ventilation to Patients With COVID-19 Clinical Trial

Official title:

The Noninvasive Ventilation to COVID-19 Patients With Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568655
• Other study ID #: FAHGuangzhouYLS03
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2020
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.

Description:

Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.We wish to raise the success rate to COVID-19 patients with respiratory failure.More critically ill COVID-19 patients could avoid the intubtion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Shortness of breath, RR>30 times per minute;

2. At room air, SpO2 lower than 93%;

3. The partial pressure of Arterial blood oxygen (PaO2)/the fraction of inspired oxygen (FiO2) = 300mmHg;

4. CT(computed tomography) chest imaging shows that lung damage develops significantly within 24 to 48 hours.

Exclusion Criteria:

1. Severe cardiovascular disease,

2. respiratory arrest,

3. cardiovascular instability (hypotension, arrhythmias, myocardial infarction),

4. change in mental status or patients who were uncooperative, high risk of aspiration, viscous or copious

5. secretions,

6. recent facial or gastroesophageal surgery,

7. craniofacial trauma, 8)fixed nasopharyngeal abnormalities,

9)burns, 10) extreme obesity.

Related Conditions & MeSH terms

• Noninvavie Ventilation to Patients With COVID-19
• Respiratory Insufficiency

Intervention

Device:
• noninvasive ventilation
noninvasive ventilation to support the COVID-19 patients with respiratory failure

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate	the sucess rate of the noninvasive ventilation	4 month
Primary	the intubtion rate	the intubtion rate of the COVID-19 patients	4 month
Secondary	blood lymphocyte	blood lymphocyte of the COVID-19 patients	4month
Secondary	B-type natriuretic peptide	blood B-type natriuretic peptide of the COVID-19 patients	4 month
Secondary	Procalcitonin	blood procalcitonin of the COVID-19 patients	4 month
Secondary	Oxygen Saturation	Oxygen Saturation of the COVID-19 patients	4 month