NCT00343993

Noninvasive Positive Pressure Ventilation for ALI/ARDS:a Multicentre Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

with appropriate inspired oxygen concentrations, NPPV would prevent intubation and hence avert the poor outcome associated with the need of invasive ventilation in patients with ALI/ARDS.

Detailed description

Noninvasive positive-pressure ventilation (NPPV) is increasingly being used in the care of patients suffering acute respiratory failure. High-level evidence supports the use of NPPV to treat exacerbation of chronic obstructive pulmonary disease (COPD). More recently, NIV has shown to reduce the need for intubation in selected groups of patients with severe cardiogenic pulmonary edema, immunosuppression, and respiratory failure after lung resection. In their subgroup analysis of the five randomized control trials, however, patients with acute lung injury (ALI) or ARDS still couldn't avoid intubation and death even treated with NPPV. Till now, there has been no randomized controlled study of NPPV in patients with ALI or ARDS. We hypothesized that in patients with ALI/ARDS, early use of NPPV, providing appropriate inspired oxygen concentrations, would prevent intubation as the primary end-point variable, hence avert the poor outcome associated with the need of invasive ventilation. Accordingly, we conducted a prospective, randomized controlled trial to assess the efficacy of NPPV compared with a standard regime consisting of high-concentration oxygen therapy.

Conditions

• Acute Lung Injury
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	noninvasive positive pressure ventilation

Timeline

• Start date: 2006-06-01
• Completion: 2007-12-01
• First posted: 2006-06-26
• Last updated: 2007-04-04

Locations

1 site across 1 country: China