Postoperative Retention of UrineNCT01309529
Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients
An observational study of Postoperative Retention of Urine and Postoperative Urinary Tract Infection, run by Memorial Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Retention of Urine, Postoperative Urinary Tract Infection
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All general thoracic surgery patients with a thoracic epidural catheter.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Hospital
Chattanooga, Tennessee, 37404
Potter, tiffany_potter@memorial.org
About this study
Official title: Day Zero Urinary Catheter Removal in General Thoracic Surgery Patients Receiving Thoracic Epidural Analgesia: Recatheterization Rates and Urinary Tract Infection Occurrences
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.
Read the 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
- 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.
- Keywords
- general thoracic surgery, epidural analgesia, postoperative retention of urine, postoperative urinary tract infection, catheter associated urinary tract infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| thoracic surg, epidural, urine retention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Retention of UrineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Health System
- Sponsor type
- University, hospital or other
- Investigators
- Laurel Rhyne, ACNP-BC, Principal investigator, Memorial Hospital-Thoracic Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309529
- Sponsor's protocol ID
- IRB11.03.01
- Status last verified
- Mar 2011
- First submitted
- 4 Mar 2011
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day Zero Urinary Catheter Removal in General Thoracic Surgery Patients Receiving Thoracic Epidural Analgesia: Recatheterization Rates and Urinary Tract Infection Occurrences
- ClinicalTrials.gov ID
- NCT01309529
- Acronym / sponsor ID
- IRB11.03.01
- Keywords
- general thoracic surgery, epidural analgesia, postoperative retention of urine, postoperative urinary tract infection, catheter associated urinary tract infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Memorial Health SystemUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracic surg, epidural, urine retention | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All general thoracic surgery patients with a thoracic epidural catheter.
Key exclusion criteria (7 listed)
- Men > 65 years old
- History of urologic procedure
- Known benign prostatic hyperplasia
- Admission to intensive care units
- History of urinary retention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurel Rhyne, ACNP-BC principal investigator
Memorial Hospital-Thoracic Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Retention of Urine and Postoperative Urinary Tract Infection, run by Memorial Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiffany E Potter, BSN (4223-495-7848, tiffany_potter@memorial.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2011.