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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Beijing Chao Yang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT00343993
First received: June 23, 2006
Last updated: April 3, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Acute Lung Injury
Acute Respiratory Distress Syndrome
Device: noninvasive positive pressure ventilation
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Beijing Chao Yang Hospital:

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

Secondary Outcome Measures:
  • Mortality in the ICU and hospital

Estimated Enrollment: 200
Study Start Date: June 2006
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343993

Contacts
Contact: Zhan Q Yuan, MD 86-10-85231543 ards@vip.163.com
Contact: Sun Bin, MD 86-0-13911151075 ards@vip.163.com

Locations
China
Beijing chaoyang hospital-affiliate of capital medical university Recruiting
Beijing, China, 100020
Contact: Zhan Q Yuan, MD    86-10-65060167    zhanqy0915@163.com   
Contact: Sun Bin, MS    86-10-85231893    ards@vip.163.com   
Principal Investigator: Wang Chen, MD         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
Study Chair: Wang Chen, MD Beijing Chaoyang Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00343993     History of Changes
Other Study ID Numbers: Y0905001040291
Study First Received: June 23, 2006
Last Updated: April 3, 2007
Health Authority: China: Ministry of Health

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
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on April 17, 2014