Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Memorial Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Memorial Health System
ClinicalTrials.gov Identifier:
NCT01309529
First received: March 4, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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
Postoperative Retention of Urine
Postoperative Urinary Tract Infection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Health System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: March 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
thoracic surg, epidural, urine retention

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309529

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

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

No publications provided

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
Study First Received: March 4, 2011
Last Updated: March 4, 2011
Health Authority: United States: Institutional Review Board

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
Infection
Urinary Retention
Urinary Tract Infections
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014