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

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00343993

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury Acute Respiratory Distress Syndrome	Device: noninvasive positive pressure ventilation	Phase 1

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2006

Anticipated Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

The intubation rate who meet the intubation criteria predefined []

Secondary Outcome Measures

Mortality in the ICU and hospital []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Meet the ALI/ARDS criteria

Exclusion Criteria:

Age > 85
pH < 7.35 or PaCO2 >50mmHg
Glasgow Coma Scale (GCS)<11
Airway or facial deformity
Pneumothorax or pneumomediastinum
Unable to spontaneously clear secretions from their airway
Respiratory arrest
Shock or hemodynamic instability (systolic blood pressure <90 mmHg associated with decreased urinary output (<20 mL.h-1) despite fluid repletion and use of vasoactive agents) of other causes
Severe ventricular arrhythmia or active myocardial ischemia
Severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score>1)
End-stage patients who are expected to survive less than six months
Severe abdominal distension
Refuse to receive NPPV
Unable to cooperate with the application of NPPV