Head Elevation in Prone Position

May 3, 2010 updated by: Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

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

  • Austria
      • Vienna, Austria, 1090
        • Dept. of Internal Medicine I, Intensive Care Unit, Medical University of Vienna

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 to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Start with turning to prone position without head elevation, after 2 hours 30° head elevation, after 2 hours back to PP without head elevation.
Procedure: Prone position with head elevation
Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)
Active Comparator: 2
Start with turning to prone position with 30° head elevation, after 2 hours PP without head elevation, after 2 hours back to 0° PP.
Procedure: Prone position with head elevation
Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PaO2/FiO2 ratio
Time Frame: Study period (5 hours on 2 consecutive days)
Study period (5 hours on 2 consecutive days)

Secondary Outcome Measures

Outcome Measure
Time Frame
PaCO2, Compliance (Chest wall, lung, respiratory system)
Time Frame: Study period (5 hours on 2 consecutive days)
Study period (5 hours on 2 consecutive days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (Estimate)

September 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2010

Last Update Submitted That Met QC Criteria

May 3, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EK 685/2007

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.

Clinical Trials on Lung Mechanics

Clinical Trials on Prone position with head elevation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe