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Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Robert Cerfolio, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00873587
First received: March 30, 2009
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Chest Tube Removal
 Procedure: Chest tube pull on inspiration
Procedure: Expiration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Pneumothorax [ Time Frame: Within 4 hours after chest tube removal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: 4 hours after chest tube removal ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Inspiration Procedure: Chest tube pull on inspiration
Pull chest tube on Inspiration
Expiration Procedure: Expiration
Pull chest tube on Expiration

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873587

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Robert J Cerfolio, MD University of Alabama at Birmingham, Department of Surgery
  More Information

No publications provided

Responsible Party: Robert Cerfolio, MD, Professor, Department of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00873587     History of Changes
Other Study ID Numbers: F081016009
Study First Received: March 30, 2009
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Thoracotomy
Inspiration
Expiration
 Chest Tube
pneumothorax
Method of chest tube removal

ClinicalTrials.gov processed this record on June 17, 2013