Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

Beijing Hospital1 site in 1 country120 target enrollmentJuly 2012

ConditionsAcute Respiratory Distress Syndrome

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Respiratory Distress Syndrome
Sponsor: Beijing Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: all cause mortality
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

December 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Hospital

Responsible Party

Principal Investigator

Chen Wang

Vice President

Beijing Hospital

Eligibility Criteria

Inclusion Criteria

•acute onset
•a clinical presentation of respiratory distress
•arterial oxygen tension/inspired oxygen fraction (PaO2/FiO2) between 200 mmHg to 300 mmHg. The arterial oxygen tension will be measured in fifteen minutes after NPPV (CPAP 5 cmH2O) was used to the patients stably
•presence of bilateral pulmonary infiltrate on chest radiograph
•no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) \< 18 mmHg

Exclusion Criteria

•age \> 70 years or \< 18 years
•PaCO2 \> 50mmHg
•Glasgow Coma Scale (GCS)\< 11
•Upper airway/facial deformity or injury
•pneumothorax or pneumomediastinum
•unable to spontaneously clear secretions from their airway
•respiratory arrest
•severe ventricular arrhythmia or active myocardial ischemia
•severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score \> 1)
•severe chronic lung diseases(COPD, Asthma or ILD, et al)

Outcomes

Primary Outcomes

all cause mortality

Time Frame: From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days