Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: invasive mechanical ventilation; Procedure: noninvasive positive pressure ventilation (NPPV)

• Registration Number: NCT01585922
• Lead Sponsor: Beijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Study Start: 2012-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. acute onset
2. a clinical presentation of respiratory distress
3. 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
4. presence of bilateral pulmonary infiltrate on chest radiograph
5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) < 18 mmHg

Exclusion Criteria

1. age > 70 years or < 18 years
2. PaCO2 > 50mmHg
3. Glasgow Coma Scale (GCS)< 11
4. Upper airway/facial deformity or injury
5. pneumothorax or pneumomediastinum
6. unable to spontaneously clear secretions from their airway
7. respiratory arrest
8. severe ventricular arrhythmia or active myocardial ischemia
9. severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score > 1)
10. severe chronic lung diseases(COPD, Asthma or ILD, et al)
11. end-stage patients who are expected to survive less than six months
12. severe abdominal distension
13. refuse to receive NPPV
14. unable to cooperate with NPPV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMV	invasive mechanical ventilation	Use invasive mechanical ventilation in treating the patients allocated to this group.
NPPV	noninvasive positive pressure ventilation (NPPV)	Use the NPPV to treat moderate ARDS

Primary Outcome Measures

Name	Time	Method
all cause mortality	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

Trial Locations

Locations (1)

Beijing Institute of Respiratory Medicine, Beijing Hospital; 🇨🇳 Beijing, Beijing, China