Head Elevation in Prone Position

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gas Exchange Lung Mechanics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Prone position with head elevation

Intervention Type PROCEDURE

Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)

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.

Group Type ACTIVE_COMPARATOR

Prone position with head elevation

Intervention Type PROCEDURE

Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)

Interventions

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Prone position with head elevation

Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No