Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients

NCT ID: NCT01309529

Last Updated: 2011-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Retention of Urine Postoperative Urinary Tract Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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thoracic surg, epidural, urine retention

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Health System

OTHER

Sponsor Role lead

Responsible Party

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Memorial Hospital-Thoracic Program

Principal Investigators

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Laurel Rhyne, ACNP-BC

Role: PRINCIPAL_INVESTIGATOR

Memorial Hospital-Thoracic Program

Locations

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Memorial Hospital

Chattanooga, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tiffany E Potter, BSN

Role: CONTACT

4223-495-7848

Laurel Rhyne, ACNP-BC

Role: CONTACT

423-495-7834

Facility Contacts

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Potter

Role: primary

Other Identifiers

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IRB11.03.01

Identifier Type: -

Identifier Source: org_study_id

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