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Software-guided Guideline Implementation in Premedication

NCT04058769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2022-10-19

No results posted yet for this study

Summary

Aim of the project is the development of a software for implementation of anesthesiology guidelines in the preoperative evaluation. The software bases on the 2014 and 2018 guidelines of the European Society of Anesthesiology (ESA) for the pre-operative evaluation of adults undergoing non-cardiac surgery.

Traditional premedication is compared with the new software-guided premedication by using a cross-over design. 200 patients are included in the study, 100 of which are first evaluated the traditional way and then with the software, 100 patients are treated the other way round. Results of the two premedication methods are compared according to the primary endpoint "correct approval for OP" and the secondary endpoints number of missed apparative examinations, number of unnecessary apparative examinations, time required for premedication, length of hospital stay, mortality and postoperative complications.

Conditions

  • Pre-operative Assessment
  • Adults
  • Non-cardiac Surgery

Interventions

DEVICE

Premedication Guide

Software with guidelines recommendations for preoperative assessment

Sponsors & Collaborators

  • Health Information Management, Belgium

    collaborator OTHER

  • Technical University of Munich

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-07-30
Completion
2022-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058769 on ClinicalTrials.gov