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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00343993
Enrollment
200
Registered
2006-06-26
Start date
2006-06-30
Completion date
2007-12-31
Last updated
2007-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Acute Respiratory Distress Syndrome

Keywords

noninvasive positive pressure ventilation, acute lung injury, acute respiratory distress syndrome

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.

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.

Interventions

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The intubation rate who meet the intubation criteria predefined

Secondary

MeasureTime frame
Mortality in the ICU and hospital

Countries

China

Contacts

Primary ContactZhan Q Yuan, MD
ards@vip.163.com86-10-85231543
Backup ContactSun Bin, MD
ards@vip.163.com86-0-13911151075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026