NCT01104285

Brief Summary

The purpose of this study is to determine whether chest tubes to drain transudative pleural effusions helps patients come off mechanical ventilation earlier.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 23, 2012

Completed
Last Updated

May 23, 2012

Status Verified

April 1, 2012

Enrollment Period

1 month

First QC Date

April 14, 2010

Results QC Date

November 16, 2011

Last Update Submit

April 18, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Days of Mechanical Ventilatory Support

    days

Study Arms (2)

Standard care

Treatment of pleural effusion with diuresis

Chest tube

Treatment of pleural effusion with diuresis and chest tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

112 patients standard; 86 patients chest tube

You may qualify if:

  • Patients with transudative pleural effusion and requiring mechanical ventilation

You may not qualify if:

  • Patients with coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Yizhak Kupfer MD
Organization
Maimonides Medical Center

Study Officials

  • Yizhak Kupfer, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pulmonary and Critical Care Medicine

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 15, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 23, 2012

Results First Posted

May 23, 2012

Record last verified: 2012-04

Locations