Prone Position for Non-intubated Patients With Acute Respiratory Failure
This study is currently recruiting participants.
Verified September 2011 by Karolinska University Hospital
Sponsor:
Karolinska University Hospital
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
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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
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 May 23, 2013