Prone Position for Non-intubated Patients With Acute Respiratory Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Karolinska University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Johan Petersson, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00526981
First received: September 6, 2007
Last updated: September 19, 2011
Last verified: September 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Karolinska University Hospital:

Primary Outcome Measures:
  • Need for intubation and mechanical ventilation [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Institutet
  More Information

No publications provided

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
Study First Received: September 6, 2007
Last Updated: September 19, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014