Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients

March 4, 2011 updated by: Memorial Health System

Day Zero Urinary Catheter Removal in General Thoracic Surgery Patients Receiving Thoracic Epidural Analgesia: Recatheterization Rates and Urinary Tract Infection Occurrences

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.

Study Overview

Detailed Description

Study Design A prospective study design will be utilized as data will be collected in a prospective manner and standard of care/current practice will be unaltered in the patient population.

Sampling will include all patients that meet the eligibility criteria from March 01, 2011 until August 01, 2011 with a goal of forty-five patients.

Data Collection Protocol

  1. The patient will be interviewed and given information regarding participation in the study by Principal Investigator and/or research team prior to surgery. Informed Consent Forms will be collected by Principal Investigator and/or research team. Principal Investigator and/or research team will collect all data on Data Collection Sheet.
  2. Thoracic epidural will be placed by the anesthesiologist in pre-op per standard protocol.

    • Location of epidural will be documented by Principal Investigator and/or research team on Data Collection Sheet. (See Appendix 1)
  3. Prior to surgery, if indicated, an indwelling urinary bladder catheter will be placed per pre-operative protocol.
  4. Post-operative documentation of time, type and settings for epidural infusion will be documented on Data Collection Sheet.
  5. Post-op eligible patients admitted to cardiothoracic step-down unit will be placed on the following protocol:

    • Thoracic Epidural will be managed by the anesthesia group.

      • Any change in prescription or dosing will be documented on the Data Collection Sheet.
    • If urinary catheter present, will be discontinued at midnight day of surgery, Day Zero; the time of discontinuation will be noted on the Data Collection Sheet.

      • If micturition occurs, amount and time will be documented on Data Collection Sheet.
      • If no spontaneous void by 0800 post-operative day (POD) 1, bladder scanning will be initiated.
      • If ≥ 400 cc per bladder scanner, the thoracic surgeon, surgeon's nurse or the Principal Investigator will not notified.
    • Any ordered interventions, the response and re- evaluation will be noted on Data Collection Sheet.

      • Urinary retention will be defined as > 400 cc and recatheterization (either intermittent or indwelling) will occur.
  6. Data will only be collected during current surgery hospitalization.

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
thoracic surg, epidural, urine retention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate rates of recatheterization due to urinary retention and occurrence of urinary tract infections in a general thoracic surgery population receiving thoracic epidural analgesia.
Time Frame: 5 months
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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Laurel Rhyne, ACNP-BC, Memorial Hospital-Thoracic Program

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

March 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

March 4, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (Estimate)

March 7, 2011

Study Record Updates

Last Update Posted (Estimate)

March 7, 2011

Last Update Submitted That Met QC Criteria

March 4, 2011

Last Verified

March 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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