Head Elevation in Prone Position

Gas Exchange Clinical Trial

Official title:

Influence of Head Elevation in Prone Position on Gas Exchange and Lung Mechanics in Patients With ALI/ARDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753129
• Other study ID #: EK 685/2007
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2008
• Last updated: May 3, 2010
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ministery of Health
• Study type: Interventional

Clinical Trial Summary

Semi-recumbent position leads to improvement of gas exchange and lung mechanics in patients suffering from ALI or ARDS. Prone positioning leads to similar effects. To date, no data on the combination of these two positioning measures exist. The investigators hypothesize that head elevation in prone position leads to improvement in gas exchange and lung mechanics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Mechanically ventilated

• ALI or ARDS

• No contraindications for prone position

Exclusion Criteria:

• Patient < 18 or > 89 years old

• Pregnancy

• Elevated intracranial pressure

• PaO2/FiO2 - ratio < 60

• ECMO

• Open abdomen

• Instable spine

• Malignant arrhythmias

• Severe hemodynamic instability

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gas Exchange
• Lung Mechanics

Intervention

Procedure:
• Prone position with head elevation
Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)

Locations

Country	Name	City	State
Austria	Dept. of Internal Medicine I, Intensive Care Unit, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio		Study period (5 hours on 2 consecutive days)	No
Secondary	PaCO2, Compliance (Chest wall, lung, respiratory system)		Study period (5 hours on 2 consecutive days)	No