NCT00873587

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

87
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

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, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 14, 2015

Status Verified

September 1, 2013

Enrollment Period

2.5 years

First QC Date

March 30, 2009

Last Update Submit

October 11, 2015

Conditions

Keywords

ThoracotomyInspirationExpirationChest TubepneumothoraxMethod of chest tube removal

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

OTHER
Procedure: Chest tube pull on inspiration

Expiration

OTHER
Procedure: Expiration

Interventions

Pull chest tube on Inspiration

Inspiration
ExpirationPROCEDURE

Pull chest tube on Expiration

Expiration

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Respiratory AspirationDeathPneumothorax

Interventions

Exhalation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPleural Diseases

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Robert J Cerfolio, MD

    University of Alabama at Birmingham, Department of Surgery

    PRINCIPAL INVESTIGATOR

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

Locations