- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37404
- Recrutement
- Memorial Hospital
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Contact:
- Potter
- E-mail: tiffany_potter@memorial.org
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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thoracic surg, epidural, urine retention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluate rates of recatheterization due to urinary retention and occurrence of urinary tract infections in a general thoracic surgery population receiving thoracic epidural analgesia.
Délai: 5 months
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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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Laurel Rhyne, ACNP-BC, Memorial Hospital-Thoracic Program
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB11.03.01
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