Head Elevation in Prone Position
Influence of Head Elevation in Prone Position on Gas Exchange and Lung Mechanics in Patients With ALI/ARDS
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMay 4, 2010
May 1, 2010
1.5 years
September 15, 2008
May 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PaO2/FiO2 ratio
Study period (5 hours on 2 consecutive days)
Secondary Outcomes (1)
PaCO2, Compliance (Chest wall, lung, respiratory system)
Study period (5 hours on 2 consecutive days)
Study Arms (2)
1
ACTIVE COMPARATORStart with turning to prone position without head elevation, after 2 hours 30° head elevation, after 2 hours back to PP without head elevation.
2
ACTIVE COMPARATORStart with turning to prone position with 30° head elevation, after 2 hours PP without head elevation, after 2 hours back to 0° PP.
Interventions
Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)
Eligibility Criteria
You may qualify if:
- Mechanically ventilated
- ALI or ARDS
- No contraindications for prone position
You may not qualify if:
- Patient \< 18 or \> 89 years old
- Pregnancy
- Elevated intracranial pressure
- PaO2/FiO2 - ratio \< 60
- ECMO
- Open abdomen
- Instable spine
- Malignant arrhythmias
- Severe hemodynamic instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Internal Medicine I, Intensive Care Unit, Medical University of Vienna
Vienna, 1090, Austria
Related Publications (1)
Robak O, Schellongowski P, Bojic A, Laczika K, Locker GJ, Staudinger T. Short-term effects of combining upright and prone positions in patients with ARDS: a prospective randomized study. Crit Care. 2011;15(5):R230. doi: 10.1186/cc10471. Epub 2011 Sep 29.
PMID: 21955757DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 15, 2008
First Posted
September 16, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
May 4, 2010
Record last verified: 2010-05