Prone Position for Non-Intubated Patients With Acute Respiratory Failure

This study is currently recruiting participants.

Verified by Karolinska University Hospital, May 2008

Sponsored by:	Karolinska University Hospital
Information provided by:	Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00526981

Purpose

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.

Condition	Intervention
Respiratory Failure	Procedure: Prone position

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prone Position for Non-Intubated Patients With Acute Respiratory Failure

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:

Need for intubation and mechanical ventilation

Estimated Enrollment:	24
Study Start Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526981

Contacts

Contact: Johan Petersson, MD

+4685172066

johan.petersson@karolinska.se

Locations

Sweden
Karolinska University Hospital Solna	Recruiting
Stockholm, Sweden, 17176
Contact: Joha Petersson, MD +46851772066 johan.petersson@karolinska.se

Sponsors and Collaborators

Karolinska University Hospital

Investigators

Principal Investigator:

Johan Petersson, MD

Karolinska University Hospital Solna

More Information

Study ID Numbers:	2007/733-31/1-4
Study First Received:	September 6, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00526981
Health Authority:	Sweden: Regional Ethical Review Board

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

ClinicalTrials.gov processed this record on January 14, 2009