- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01309529
Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients
Day Zero Urinary Catheter Removal in General Thoracic Surgery Patients Receiving Thoracic Epidural Analgesia: Recatheterization Rates and Urinary Tract Infection Occurrences
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
- Rekruttering
- Memorial Hospital
-
Ta kontakt med:
- Potter
- E-post: tiffany_potter@memorial.org
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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thoracic surg, epidural, urine retention
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Evaluate rates of recatheterization due to urinary retention and occurrence of urinary tract infections in a general thoracic surgery population receiving thoracic epidural analgesia.
Tidsramme: 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.
|
5 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Laurel Rhyne, ACNP-BC, Memorial Hospital-Thoracic Program
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB11.03.01
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