Prone Position for Non-intubated Patients With Acute Respiratory Failure
Primary Purpose
Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Prone position
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure
Eligibility 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
Sites / Locations
- Karolinska University Hospital SolnaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Prone position + all conventional treatment.
Conventional treatment
Outcomes
Primary Outcome Measures
Need for intubation and mechanical ventilation
Secondary Outcome Measures
Full Information
NCT ID
NCT00526981
First Posted
September 6, 2007
Last Updated
September 19, 2011
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00526981
Brief Title
Prone Position for Non-intubated Patients With Acute Respiratory Failure
Official Title
Prone Position for Non-intubated Patients With Acute Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Prone position + all conventional treatment.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional treatment
Intervention Type
Other
Intervention Name(s)
Prone position
Intervention Description
Prone position during spontaneous breathing.
Primary Outcome Measure Information:
Title
Need for intubation and mechanical ventilation
Time Frame
Duration of hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Petersson, MD
Phone
+4685172066
Email
johan.petersson@karolinska.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Petersson, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joha Petersson, MD
Phone
+46851772066
Email
johan.petersson@karolinska.se
12. IPD Sharing Statement
Learn more about this trial
Prone Position for Non-intubated Patients With Acute Respiratory Failure
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