Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients

Postoperative Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01309529
• Other study ID #: IRB11.03.01
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2011
• Last updated: March 4, 2011
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2011
• Source: Memorial Health System
• Contact: Tiffany E Potter, BSN
• Phone: 4223-495-7848
• Email: tiffany_potter[@]memorial.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Postoperative Retention of Urine
• Postoperative Urinary Tract Infection
• Urinary Retention
• Urinary Tract Infections

Locations

Country	Name	City	State
United States	Memorial Hospital	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate rates of recatheterization due to urinary retention and occurrence of urinary tract infections in a general thoracic surgery population receiving thoracic epidural analgesia.	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	No