NCT00574002

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

December 12, 2007

Last Update Submit

January 5, 2017

Conditions

Thoracic SurgeryThoracic Trauma

Outcome Measures

Primary Outcomes (2)

  • Repeat chest tube insertion within 30 days

    two years

  • Thoracotomy on affected side within 30 days

    Two years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgery patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Study Officials

  • Gerald L. Early, M.D., M.A.

    Truman Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

December 1, 2007

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

US(1)