Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal

October 11, 2015 updated by: University of Alabama at Birmingham

Randomized Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal

There are two commonly used methods to remove chest tubes following thoracotomy. One is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and hold it). There has been considerable discussion among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax, the most common complication associated with chest tube removal. The investigators will compare the two methods, and also identify risk factors of developing pneumothorax during chest tube removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND
  • Have at least one chest tube.

Exclusion Criteria:

  • Less than 19 years old,
  • With interstitial lung disease, OR
  • Any patient intubated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Inspiration
Procedure: Chest tube pull on inspiration
Pull chest tube on Inspiration
Other: Expiration
Procedure: Expiration
Pull chest tube on Expiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pneumothorax
Time Frame: Within 4 hours after chest tube removal
Within 4 hours after chest tube removal

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity
Time Frame: 4 hours after chest tube removal
4 hours after chest tube removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Robert J Cerfolio, MD, University of Alabama at Birmingham, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 11, 2015

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • F081016009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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