Establishing Safe Drainage Limits for Pleural Chest Tube... | NCT00574002

Studies
Establishing Safe Drainage Limits for Pleural Chest Tube Removal.

NCT00574002

Sponsor

University of Missouri, Kansas City

Status

Withdrawn

Last Update Posted

Jan 9, 2017Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Thoracic Surgery
Thoracic Trauma

Interventions

Not provided

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low study enrollment; re-evaluating study protocol and study selection criteria.

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 14, 2007Estimated

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

Jan 5, 2017

Last Update Posted Date

Jan 9, 2017Estimated

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

The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present.

Detailed Description

Measurement of pleural fluid drainage in chest tubes of trauma patients.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Patients that have their chest tube removed when drainage is 400mL or less in 24 hours.
Group B.		Patients that have their chest tube removed when drainage is 200mL or less in 24 hours.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Repeat chest tube insertion within 30 days		two years
Thoracotomy on affected side within 30 days		Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of at least one chest tube
No air leak present
Fluid is not infected
Pleural drainage of fluid was an indication for placement of the chest tube
Patient is post-thoracic surgery
Patient is post-thoracic trauma
Informed consent obtained

Exclusion Criteria:

Presence of air leak
Infected pleural fluid
Active intra-thoracic bleeding
Thoracic empyema
Non-removal of chest tube (i.e.: expired)
Pregnancy
Less than 18 years of age
Unable to obtain informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Surgery patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerald L. Early, M.D., M.A.	Truman Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Truman Medical Center		Kansas City	Missouri	64108	United States