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

Capital Medical University

Status and phase

Unknown

Phase 1

Conditions

Acute Respiratory Distress Syndrome

Acute Lung Injury

Treatments

Device: noninvasive positive pressure ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT00343993

Y0905001040291

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 70 years old

Volunteers

No 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