Prone Position for Non-intubated Patients With Acute Respiratory Failure

Respiratory Failure Clinical Trial

Official title:

Prone Position for Non-intubated Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00526981
• Other study ID #: 2007/733-31/1-4
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2007
• Last updated: September 19, 2011
• Start date: September 2007

Study information

• Verified date: September 2011
• Source: Karolinska University Hospital
• Contact: Johan Petersson, MD
• Phone: +4685172066
• Email: johan.petersson[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Prone position
Prone position during spontaneous breathing.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for intubation and mechanical ventilation		Duration of hospital stay	No