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Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients

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ClinicalTrials.gov Identifier: NCT01309529
Recruitment Status : Unknown
Verified March 2011 by Memorial Health System.
Recruitment status was:  Recruiting
First Posted : March 7, 2011
Last Update Posted : March 7, 2011
Information provided by:
Memorial Health System

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.

Condition or disease
Postoperative Retention of Urine Postoperative Urinary Tract Infection

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
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Day Zero Urinary Catheter Removal in General Thoracic Surgery Patients Receiving Thoracic Epidural Analgesia: Recatheterization Rates and Urinary Tract Infection Occurrences
Study Start Date : March 2011
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

thoracic surg, epidural, urine retention

Primary Outcome Measures :
  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. [ 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309529

Contact: Tiffany E Potter, BSN 4223-495-7848 tiffany_potter@memorial.org
Contact: Laurel Rhyne, ACNP-BC 423-495-7834 laurel_rhyne@memorial.org

United States, Tennessee
Memorial Hospital Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Potter       tiffany_potter@memorial.org   
Sponsors and Collaborators
Memorial Health System
Principal Investigator: Laurel Rhyne, ACNP-BC Memorial Hospital-Thoracic Program

Responsible Party: Laurel Rhyne, MSN, MEd, ACNP-BC, Memorial Hospital-Thoracic Program
ClinicalTrials.gov Identifier: NCT01309529     History of Changes
Other Study ID Numbers: IRB11.03.01
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011

Keywords provided by Memorial Health System:
general thoracic surgery
epidural analgesia
postoperative retention of urine
postoperative urinary tract infection
catheter associated urinary tract infection

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urinary Retention
Urologic Diseases
Urination Disorders