Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease|
|Postoperative Retention of Urine Postoperative Urinary Tract Infection|
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.
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|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|
|thoracic surg, epidural, urine retention|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309529
|Contact: Tiffany E Potter, BSNemail@example.com|
|Contact: Laurel Rhyne, ACNP-BCfirstname.lastname@example.org|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37404|
|Contact: Potter email@example.com|
|Principal Investigator:||Laurel Rhyne, ACNP-BC||Memorial Hospital-Thoracic Program|