The Noninvasive Ventilation to COVID-19 Patients

Completed

• Conditions: Noninvavie Ventilation to Patients With COVID-19
• Interventions: Device: noninvasive ventilation

• Registration Number: NCT04568655
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-09-28
• Last Update Submitted: 2020-09-28
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 patients need noninvasive ventilation	noninvasive ventilation	-

Primary Outcome Measures

Name	Time	Method
the intubtion rate	4 month	the intubtion rate of the COVID-19 patients
success rate	4 month	the sucess rate of the noninvasive ventilation

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation	4 month	Oxygen Saturation of the COVID-19 patients
blood lymphocyte	4month	blood lymphocyte of the COVID-19 patients
Procalcitonin	4 month	blood procalcitonin of the COVID-19 patients
B-type natriuretic peptide	4 month	blood B-type natriuretic peptide of the COVID-19 patients

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China