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Prone Position for Non-intubated Patients With Acute Respiratory Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Johan Petersson, Karolinska University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00526981
First Posted: September 10, 2007
Last Update Posted: September 20, 2011
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.
Information provided by (Responsible Party):
Johan Petersson, Karolinska University Hospital
  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 Other: Prone position

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prone Position for Non-intubated Patients With Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Johan Petersson, Karolinska University Hospital:

Primary Outcome Measures:
  • Need for intubation and mechanical ventilation [ Time Frame: Duration of hospital stay ]

Estimated Enrollment: 24
Study Start Date: September 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Prone position + all conventional treatment.
Other: Prone position
Prone position during spontaneous breathing.
No Intervention: Control
Conventional treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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 Institutet
  More Information

Responsible Party: Johan Petersson, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00526981     History of Changes
Other Study ID Numbers: 2007/733-31/1-4
First Submitted: September 6, 2007
First Posted: September 10, 2007
Last Update Posted: September 20, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases