Gas ExchangePhase 2NCT00753129
Head Elevation in Prone Position
A Phase 2 study testing Prone position with head elevation in people with Gas Exchange and Lung Mechanics, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Gas Exchange, Lung Mechanics
- What is being tested?
- Prone position with head elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2008to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanically ventilated
- ALI or ARDS
- No contraindications for prone position
Who cannot join
- Patient < 18 or > 89 years old
- Pregnancy
- Elevated intracranial pressure
- PaO2/FiO2 - ratio < 60
- ECMO
- Open abdomen
Show all 9Show fewer
- Instable spine
- Malignant arrhythmias
- Severe hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Internal Medicine I, Intensive Care Unit, Medical University of Vienna
Vienna, 1090
About this study
Official title: 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.
- Conditions
- Gas Exchange, Lung Mechanics
- Being tested
- Prone position with head elevation
- Keywords
- Prone position, ALI/ARDS, Head elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone position with head elevationProcedure or surgery
Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Start with turning to prone position without head elevation, after 2 hours 30° head elevation, after 2 hours back to PP without head elevation. Receives: Procedure: Prone position with head elevation |
| 2 | Active comparator | Start with turning to prone position with 30° head elevation, after 2 hours PP without head elevation, after 2 hours back to 0° PP. Receives: Procedure: Prone position with head elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
Measured: Study period (5 hours on 2 consecutive days)
Secondary outcomes (1)
PaCO2, Compliance (Chest wall, lung, respiratory system)
Measured: Study period (5 hours on 2 consecutive days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gas ExchangeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753129
- Sponsor's protocol ID
- EK 685/2007
- Status last verified
- May 2010
- First submitted
- 15 Sep 2008
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21955757
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Head Elevation in Prone Position on Gas Exchange and Lung Mechanics in Patients With ALI/ARDS
- ClinicalTrials.gov ID
- NCT00753129
- Acronym / sponsor ID
- EK 685/2007
- Conditions
- Gas Exchange, Lung Mechanics
- Keywords
- Prone position, ALI/ARDS, Head elevation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Prone position with head elevationStart 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 comparator | Procedure: Prone position with head elevationStart with turning to prone position with 30° head elevation, after 2 hours PP without head elevation, after 2 hours back to 0° PP. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanically ventilated
- ALI or ARDS
- No contraindications for prone position
Key exclusion criteria (9 listed)
- Patient < 18 or > 89 years old
- Pregnancy
- Elevated intracranial pressure
- PaO2/FiO2 - ratio < 60
- ECMO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone position with head elevationHead elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed) | Procedure or surgery | 1, 2 |
Primary outcome
PaO2/FiO2 ratio
Time frame: Study period (5 hours on 2 consecutive days)
1 secondary outcome
PaCO2, Compliance (Chest wall, lung, respiratory system)
Time frame: Study period (5 hours on 2 consecutive days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2010.
- Derived from this study: PubMed 21955757Robak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prone position with head elevation in people with Gas Exchange and Lung Mechanics, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 ratio (time frame: Study period (5 hours on 2 consecutive days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00753129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2010.