- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00343993
Noninvasive Positive Pressure Ventilation for ALI/ARDS:a Multicentre Randomized Controlled Trial
April 3, 2007 updated by: Beijing Chao Yang Hospital
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Enrollment
200
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhan Q Yuan, MD
- Phone Number: 86-10-85231543
- Email: ards@vip.163.com
Study Contact Backup
- Name: Sun Bin, MD
- Phone Number: 86-0-13911151075
- Email: ards@vip.163.com
Study Locations
-
-
-
Beijing, China, 100020
- Recruiting
- Beijing chaoyang hospital-affiliate of capital medical university
-
Contact:
- Zhan Q Yuan, MD
- Phone Number: 86-10-65060167
- Email: zhanqy0915@163.com
-
Contact:
- Sun Bin, MS
- Phone Number: 86-10-85231893
- Email: ards@vip.163.com
-
Principal Investigator:
- Wang Chen, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The intubation rate who meet the intubation criteria predefined
|
Secondary Outcome Measures
Outcome Measure |
---|
Mortality in the ICU and hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Wang Chen, MD, Beijing Chao Yang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion (Anticipated)
December 1, 2007
Study Registration Dates
First Submitted
June 23, 2006
First Submitted That Met QC Criteria
June 23, 2006
First Posted (Estimate)
June 26, 2006
Study Record Updates
Last Update Posted (Estimate)
April 4, 2007
Last Update Submitted That Met QC Criteria
April 3, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Y0905001040291
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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