The Noninvasive Ventilation to COVID-19 Patients

The Noninvasive Ventilation to COVID-19 Patients With Respiratory Failure

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.

Study Overview

• Status: Completed
• Conditions: Noninvavie Ventilation to Patients With COVID-19
• Intervention / Treatment: Device: noninvasive ventilation

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 Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 520120
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

respiratory failure patients with COVID-19

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 patients need noninvasive ventilation	Device: noninvasive ventilation; noninvasive ventilation to support the COVID-19 patients with respiratory failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	the sucess rate of the noninvasive ventilation	4 month
the intubtion rate	the intubtion rate of the COVID-19 patients	4 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood lymphocyte	blood lymphocyte of the COVID-19 patients	4month
B-type natriuretic peptide	blood B-type natriuretic peptide of the COVID-19 patients	4 month
Procalcitonin	blood procalcitonin of the COVID-19 patients	4 month
Oxygen Saturation	Oxygen Saturation of the COVID-19 patients	4 month

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; respiratory failure; noninvavie ventilation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FAHGuangzhouYLS03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: the IPD are going to share after the paper published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No