Viewing Study NCT04582513



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Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04582513
Status: UNKNOWN
Last Update Posted: 2020-11-03
First Post: 2020-09-26

Brief Title: Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome
Sponsor: University Hospital Heidelberg
Organization: University Hospital Heidelberg

Study Overview

Official Title: Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome AnCHor - Checklist Pilot Trial
Status: UNKNOWN
Status Verified Date: 2020-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: AnCHor
Brief Summary: The aim of the study is to collect information on feasibility and effect size of a confirmatory prospective study with the question Does a standardized checklist during intraoperative handover of anaesthesia care reduce the rate of postoperative complications
Detailed Description: During clinical routine intraoperative handover of anaesthesia care occurs frequently This handover between two anaesthesiologists requires the transmission of all relevant information concerning the patient and the ongoing procedure Studies regarding the influence of such handovers on patient outcome are inconclusive and mostly of retrospective nature Some studies report a negative effect of handovers on patients mortality and outcome however studies exist reporting no effect A positive effect of intraoperative handovers as a result of a second man effect ist also possible To increase handover quality the German Society of Anaesthesiology and Intensive Care Medicine DGAI recommends the application of the situation background assessment and recommendation SBAR concept Information are arranged in those four groups with the goal of structuring the handover and incorporating all relevant information Studies show increased accuracy of transferred information and improved comprehensibility when using the SBAR concept Whether an intraoperative handover according to the SBAR concept reduces the rate of postoperative complications is not yet investigated Due to lack of information regarding feasibility and effect size the investigators plan a prospective pilot study to answer these questions Initially patients undergoing major surgery are recruited where handover is performed without a standardized handover After the implementation of a checklist using the SBAR concept this checklist will be used during intraoperative handover in recruited patients where a handover occurs The primary endpoint is a combined endpoint consisting of all-cause mortality readmission to any hospital or major postoperative complications Additionally implementation rate and efficacy of the checklist will be evaluated

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None