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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343993
Recruitment Status : Unknown
Verified April 2007 by Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2006
Last Update Posted : April 4, 2007
Information provided by:
Beijing Chao Yang Hospital

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 Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : June 2006
Estimated Study Completion Date : December 2007

Primary Outcome Measures :
  1. The intubation rate who meet the intubation criteria predefined

Secondary Outcome Measures :
  1. Mortality in the ICU and hospital

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343993

Contact: Zhan Q Yuan, MD 86-10-85231543
Contact: Sun Bin, MD 86-0-13911151075

Beijing chaoyang hospital-affiliate of capital medical university Recruiting
Beijing, China, 100020
Contact: Zhan Q Yuan, MD    86-10-65060167   
Contact: Sun Bin, MS    86-10-85231893   
Principal Investigator: Wang Chen, MD         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Study Chair: Wang Chen, MD Beijing Chao Yang Hospital Identifier: NCT00343993     History of Changes
Other Study ID Numbers: Y0905001040291
First Posted: June 26, 2006    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2007

Keywords provided by Beijing Chao Yang Hospital:
noninvasive positive pressure ventilation
acute lung injury
acute respiratory distress syndrome

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries