Pneumonia, Ventilator-AssociatedNCT00529776
Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy
A study testing Continuous lateral rotation therapy in people with Pneumonia, Ventilator-Associated, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Continuous lateral rotation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2005to May 2008
- Phase
- Interventional
- 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
- Intubated not longer than 48 h
- Medical cause for ICU admission
- Expected to be ventilated for > 48 hours
Who cannot join
- Pneumonia or ARDS present
- Postoperative patient
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna General Hospital, Medical University of Vienna
Vienna, 1090
About this study
Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds.
Patients are randomized to CLRT or supine position if mechanically ventilated and not suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are length of ventilation, length of stay and mortality.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Continuous lateral rotation therapy
- Keywords
- Prevention of ventilator associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous lateral rotation therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Continuous lateral rotation therapy Receives: Procedure: Continuous lateral rotation therapy |
| 2 | No intervention | Standard manual positioning (Supine position) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator associated pneumonia
Secondary outcomes (3)
Length of hospital stay
Length of mechanical ventilation
ICU and hospital Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2005
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Staudinger, MD, Principal investigator, Department of Internal Medicine I, Medical University of Vienna, AustriaThomas Staudinger, MD, Principal investigator, Dept. of Internal Medicine I, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529776
- Sponsor's protocol ID
- EK 38/2004
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2007
- Last updated
- 11 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy
- ClinicalTrials.gov ID
- NCT00529776
- Acronym / sponsor ID
- EK 38/2004
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Prevention of ventilator associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- May 2008 (actual)
- First posted
- 14 Sep 2007 (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.
Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds.
Patients are randomized to CLRT or supine position if mechanically ventilated and not suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are length of ventilation, length of stay and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Continuous lateral rotation therapyContinuous lateral rotation therapy |
| 2 | No intervention | –Standard manual positioning (Supine position) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mechanically ventilated
- Intubated not longer than 48 h
- Medical cause for ICU admission
- Expected to be ventilated for > 48 hours
Key exclusion criteria (2 listed)
- Pneumonia or ARDS present
- Postoperative patient
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 |
|---|---|---|
| Continuous lateral rotation therapy | Procedure or surgery | 1 |
Primary outcome
Ventilator associated pneumonia
3 secondary outcomes
Length of hospital stay
Length of mechanical ventilation
ICU and hospital Mortality
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 11 Jun 2008.
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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.
Thomas Staudinger, MD principal investigator
Department of Internal Medicine I, Medical University of Vienna, Austria
Thomas Staudinger, MD principal investigator
Dept. of Internal Medicine I, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous lateral rotation therapy in people with Pneumonia, Ventilator-Associated, 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 4 inclusion and 2 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 11 Jun 2008. 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.
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?
Ventilator associated pneumonia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2008.