- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526981
Prone Position for Non-intubated Patients With Acute Respiratory Failure
September 19, 2011 updated by: Johan Petersson, Karolinska University Hospital
The study will test the hypothesis that the prone position can be used to reduce the need for intubation and mechanical ventilation in patients with acute respiratory failure.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
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: Johan Petersson, MD
- Phone Number: +4685172066
- Email: johan.petersson@karolinska.se
Study Locations
-
-
-
Stockholm, Sweden, 17176
- Recruiting
- Karolinska University Hospital Solna
-
Contact:
- Joha Petersson, MD
- Phone Number: +46851772066
- Email: johan.petersson@karolinska.se
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- bilateral pulmonary infiltrates or unilateral infiltrates involving more than one lobe on CXR
- PaO2/FIO2 < 40 kPa
- RR > 25, or attending intensivist considering likelihood of intubation > 50%
Exclusion Criteria:
- unsuited for the prone position
- fulfilled inclusion criteria for more than 5 days (120 h)
- immunosuppression
- chronic lung disease
- decision of withdrawal or limitation of therapy
- pulmonary infiltrates of cardiac origin
- decreased GCS level
- PaCO2 > 10
- attending intensivist considering the patient unsuited for the prone position
- BMI > 33
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Conventional treatment
|
|
Experimental: Treatment
Prone position + all conventional treatment.
|
Prone position during spontaneous breathing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Need for intubation and mechanical ventilation
Time Frame: Duration of hospital stay
|
Duration of hospital stay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Johan Petersson, MD, Karolinska Institutet
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
September 1, 2007
Primary Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
September 6, 2007
First Submitted That Met QC Criteria
September 6, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Estimate)
September 20, 2011
Last Update Submitted That Met QC Criteria
September 19, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007/733-31/1-4
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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