Clinical Trial Evaluating the Optimal Technique for Chest... | NCT00873587

Studies
Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal

NCT00873587

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Oct 14, 2015Estimated

Enrollment

342Actual

Phase

Not Applicable

Conditions

Chest Tube Removal

Interventions

Chest tube pull on inspiration
Expiration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2012Actual

First Submitted Date

Mar 30, 2009

First Submission Date that Met QC Criteria

Mar 31, 2009

First Posted Date

Apr 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2015

Last Update Posted Date

Oct 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

342Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inspiration	Other		Procedure: Chest tube pull on inspiration
Expiration	Other		Procedure: Expiration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chest tube pull on inspiration	Procedure	Pull chest tube on Inspiration	Inspiration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pneumothorax		Within 4 hours after chest tube removal

Secondary Outcomes

Measure	Description	Time Frame
Morbidity		4 hours after chest tube removal

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert J Cerfolio, MD	University of Alabama at Birmingham, Department of Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration
D003643	Death
D011030	Pneumothorax

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D045853	Exhalation

Ancestor Terms

ID	Term
D015656	Respiratory Mechanics
D012119	Respiration
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided