Liberation From Mechanical VentilationNCT01104285
Chest Tube Drainage of Transudative Pleural Effusions Hastens Liberation From Mechanical Ventilation
An observational study of Liberation From Mechanical Ventilation, run by Maimonides Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether chest tubes to drain transudative pleural effusions helps patients come off mechanical ventilation earlier. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liberation From Mechanical Ventilation
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Apr 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 112 patients standard; 86 patients chest tube
Who may be able to join
- Patients with transudative pleural effusion and requiring mechanical ventilation
Who cannot join
- Patients with coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether chest tubes to drain transudative pleural effusions helps patients come off mechanical ventilation earlier.
- Conditions
- Liberation From Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Treatment of pleural effusion with diuresis | |
| Chest tube | Treatment of pleural effusion with diuresis and chest tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Days of Mechanical Ventilatory Support
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liberation From Mechanical VentilationStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidney Tessler, Maimonides Medical Center
- Investigators
- Yizhak Kupfer, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104285
- Sponsor's protocol ID
- 10/03/VA02
- Status last verified
- Apr 2012
- First submitted
- 14 Apr 2010
- Last updated
- 23 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kupfer Y, Seneviratne C, Chawla K, Ramachandran K, Tessler S. Chest tube drainage of transudative pleural effusions hastens liberation from mechanical ventilation. Chest. 2011 Mar;139(3):519-523. doi: 10.1378/chest.10-1012. Epub 2010 Aug 5.
PubMed 20688921
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Tube Drainage of Transudative Pleural Effusions Hastens Liberation From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01104285
- Acronym / sponsor ID
- 10/03/VA02
- Conditions
- Liberation From Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Posted 23 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether chest tubes to drain transudative pleural effusions helps patients come off mechanical ventilation earlier.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | – | –Treatment of pleural effusion with diuresis |
| Chest tube | – | –Treatment of pleural effusion with diuresis and chest tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 112 patients standard; 86 patients chest tube
Key inclusion criteria (1 listed)
- Patients with transudative pleural effusion and requiring mechanical ventilation
Key exclusion criteria (1 listed)
- Patients with coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Days of Mechanical Ventilatory Support
Time frame: days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20688921Kupfer Y, Seneviratne C, Chawla K, Ramachandran K, Tessler S. Chest tube drainage of transudative pleural effusions hastens liberation from mechanical ventilation. Chest. 2011 Mar;139(3):519-523. doi: 10.1378/chest.10-1012. Epub 2010 Aug 5.
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The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation
Liberation From Mechanical Ventilation
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.
Yizhak Kupfer, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liberation From Mechanical Ventilation, run by Maimonides Medical Center at 1 site in United States.
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 1 inclusion and 1 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 23 May 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Days of Mechanical Ventilatory Support (time frame: 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 NCT01104285, 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 23 May 2012; AzTrials last refreshed its copy on 8 Nov 2026.