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

Status

Unknown

Conditions

Intervention / Treatment

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 Locations

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.
Other: Prone position
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

Karolinska University Hospital

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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