Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients
Recruitment status was: Recruiting
Postoperative Retention of Urine
Postoperative Urinary Tract Infection
|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|
- 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.
|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)|
|thoracic surg, epidural, urine retention|
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
- 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.
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)
- Prior to surgery, if indicated, an indwelling urinary bladder catheter will be placed per pre-operative protocol.
- Post-operative documentation of time, type and settings for epidural infusion will be documented on Data Collection Sheet.
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.
- Data will only be collected during current surgery hospitalization.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309529
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37404|
|Principal Investigator:||Laurel Rhyne, ACNP-BC||Memorial Hospital-Thoracic Program|