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

Acute Respiratory Distress Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00343993
• Other study ID #: Y0905001040291
• Status: Recruiting
• Phase: Phase 1
• First received: June 23, 2006
• Last updated: April 3, 2007
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2007
• Source: Beijing Chao Yang Hospital
• Contact: Zhan Q Yuan, MD
• Phone: 86-10-85231543
• Email: ards[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• noninvasive positive pressure ventilation

Locations

Country	Name	City	State
China	Beijing chaoyang hospital-affiliate of capital medical university	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intubation rate who meet the intubation criteria predefined
Secondary	Mortality in the ICU and hospital