Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal
Randomized Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal
1 other identifier
interventional
342
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 30, 2009
CompletedFirst Posted
Study publicly available on registry
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedOctober 14, 2015
September 1, 2013
2.5 years
March 30, 2009
October 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pneumothorax
Within 4 hours after chest tube removal
Secondary Outcomes (1)
Morbidity
4 hours after chest tube removal
Study Arms (2)
Inspiration
OTHERExpiration
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND
- Have at least one chest tube.
You may not qualify if:
- Less than 19 years old,
- With interstitial lung disease, OR
- Any patient intubated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Cerfolio, MD
University of Alabama at Birmingham, Department of Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2009
First Posted
April 1, 2009
Study Start
March 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2012
Last Updated
October 14, 2015
Record last verified: 2013-09