Establishing Safe Drainage Limits for Pleural Chest Tube Removal.

January 5, 2017 updated by: University of Missouri, Kansas City

Defining the Threshold for Safe Chest Tube Removal.

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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

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

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Missouri
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgery patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Investigators

Principal Investigator: Gerald L. Early, M.D., M.A., Truman Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria