Mortality After Endoscopic Retrograde Cholangiopancreatography

Completed

• Conditions: Cholangiopancreatography, Endoscopic Retrograde; Deep Sedation; Mortality

• Registration Number: NCT02983331
• Lead Sponsor: Gulsah Karaoren

Brief Summary

In this study, the investigators aimed to overview patients with specific and non-specific complications who admitted to intensive care unit following endoscopic retrograde cholangiopancreatography and had fatal course in the facility

Detailed Description

The investigators retrospectively reviewed patients who underwent elective or emergent endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation protocol (midazolam 0.02 mgkg-1; fentanyl, 1 mgkg-1; propofol 1 mgkg-1) between 2011 and 2016 after approval of local ethics committee of Umraniye Training Hospital.

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-11-27
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-01
• Last Update Submitted: 2016-12-01
• Study First Posted: 2016-12-06
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1471

Inclusion Criteria

• Patients who underwent elective or emergent ERCP at semi-prone position with routine monitoring and standard sedation protocol

Exclusion Criteria

• Patients who discharged to ward after treatment and follow-up in ICU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of anaesthesia related mortality of the endoscopic retrograde cholangiopancreatographyprocedure under sedation	5 years	We identified patients who developed complications during procedure and admitted to intensive care unit (ICU).
Number of Participants With endoscopic retrograde cholangiopancreatography Related complications	5 years	We retrospectively reviewed patients who underwent elective or emergent endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation protocol

Secondary Outcome Measures

Name	Time	Method
Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality	5 years
Value of Charlson comorbidity index (CCI) score for predicting mortality	5 years

Trial Locations

Locations (1)

Istanbul Umraniye Training Hospital; 🇹🇷 Istanbul, Turkey