Software-guided Guideline Implementation in Premedication
SGGIP
Software Development for Anesthesiology Guideline Implementation in the Perioperative Course
1 other identifier
interventional
203
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2019
CompletedFirst Posted
Study publicly available on registry
August 16, 2019
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedOctober 19, 2022
March 1, 2022
1.2 years
August 8, 2019
October 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
correct approval for operation
number of patients that were approved correctly for surgery
1 day
Secondary Outcomes (5)
missing examinations
1 day
unnecessary examinations
1 day
mortality
30 days
length of hospital stay
30 days
postoperative complications
30 days
Study Arms (2)
Software first
OTHERPatients that are pre-operatively assessed first software-guided and then traditional
Traditional
OTHERPatients that are first pre-operatively assessed in the traditional way and then with aid of the software
Interventions
Software with guidelines recommendations for preoperative assessment
Eligibility Criteria
You may qualify if:
- age \>= 18 years
- ASA 3 or 4
- elective surgery
- written informed consent
You may not qualify if:
- emergency surgery
- patient not being able to give informed consent
- non-german-speaking patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TU Muenchen
Munich, 81675, Germany
Related Publications (1)
Kagerbauer SM, Wissler J, Andonov DI, Ulm B, Schneider G, Podtschaske AH, Blobner M, Jungwirth B. Implementation of a software-based decision support tool for guideline-appropriate preoperative evaluation: a prospective agreement study. Br J Anaesth. 2024 Sep;133(3):519-529. doi: 10.1016/j.bja.2024.06.001. Epub 2024 Jul 5.
PMID: 38971713DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2019
First Posted
August 16, 2019
Study Start
May 1, 2021
Primary Completion
July 30, 2022
Study Completion
September 30, 2022
Last Updated
October 19, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share