NCT01309529

Brief Summary

Current standard of practice in study institution dictates day of surgery urinary catheter removal in general thoracic surgery patients receiving thoracic epidural analgesia. The investigators hypothesize that this practice results in low recatheterization rates secondary to urinary retention and low urinary tract infection rates.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

March 4, 2011

Last Update Submit

March 4, 2011

Conditions

Postoperative Retention of UrinePostoperative Urinary Tract Infection

Keywords

general thoracic surgeryepidural analgesiapostoperative retention of urinepostoperative urinary tract infectioncatheter associated urinary tract infection

Outcome Measures

Primary Outcomes (1)

  • Evaluate rates of recatheterization due to urinary retention and occurrence of urinary tract infections in a general thoracic surgery population receiving thoracic epidural analgesia.

    The current standard of care at study institution is to remove urinary catheter on post operative day zero lowering urinary tract infection and recatheterization rates.

    5 months

Study Arms (1)

thoracic surg, epidural, urine retention

Eligibility Criteria

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

General thoracic surgery patients with a thoracic epidural that meet the eligibility criteria admitted to a specific tertiary care facility starting March 1, 2011 and ending August 1, 2011.

You may qualify if:

  • All general thoracic surgery patients with a thoracic epidural catheter.

You may not qualify if:

  • Men \> 65 years old
  • History of urologic procedure
  • Known benign prostatic hyperplasia
  • Admission to intensive care units
  • History of urinary retention
  • Foreign speaking patient
  • Pregnant women and those less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hospital

Chattanooga, Tennessee, 37404, United States

RECRUITING

Study Officials

  • Laurel Rhyne, ACNP-BC

    Memorial Hospital-Thoracic Program

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany E Potter, BSN

CONTACT

4223-495-7848tiffany_potter@memorial.org

Laurel Rhyne, ACNP-BC

CONTACT

423-495-7834laurel_rhyne@memorial.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 7, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2011

Study Completion

October 1, 2011

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(1)