Software-guided Guideline Implementation in Premedication (SGGIP)

Software Development for Anesthesiology Guideline Implementation in the Perioperative Course

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.

Study Overview

• Status: Completed
• Conditions: Adults; Non-cardiac Surgery; Pre-operative Assessment
• Intervention / Treatment: Device: Premedication Guide

Detailed Description

Type of study:

Monocentric, prospective cohort study

Procedure for informing and obtaining consent:

Patients who are prepared for surgery in the anesthetic outpatient department or enrolled in the pre-medication list and who meet all inclusion criteria and no exclusion criteria will be identified before the anesthesia consultation. The patients will be informed about the purpose and the course of the study in oral and written form, after which the written consent of the patient will be given before the study-relevant data and examinations are carried out.

Description of the data sources (medical records, questionnaires, etc.):

Data Sources: Patient's medical history, patient history and physical examination, data on standardized Thieme Compliance anesthesia sheets, and existing findings, either external, patient-brought or in-house findings from the SAP. These data are entered into the PDMS. The name of the premedic anesthetist is not relevant for the evaluation and will not be deposited.

Listing / description of the data to be collected:

With the PDMS, all anesthesia-relevant data is collected. These include the history of the patient, current complaints, medication history, physical examination and findings from supplementary equipment examinations. The data of the anonymized control group are extracted exclusively from the PDMS.

Timing (appointments) for the individual study participant:

After the patient has been informed and has consented, after randomization either the premedication as usual with the "old PDMS module" is performed and then a second time with the new software module by another doctor or vice versa, first with the new software and then in the traditional way. This type of cross-over design is done to avoid carry-over effects. The conventional premedicating physician does not know about the patient's participation in the study and makes the decision about the OP release as well as any necessary additional examinations in the usual way and dismisses the patient with the usual pre-hospitalization standard.

The premedication with the new software module is carried out by a doctor who has been trained in it and does not know the result of the first premedication interview. With the help of the new software, the decision on release and possible additional examinations is also made here. The data from the two premedication interviews are stored in xml format in the MRI Data Room and entered in a pseudonymized form in a database. This is done promptly on the day of premedication. A specialist trained in the guidelines, who is blinded to the premedication procedure, compares the results of both premedications. He decides whether the release was correct in both of the above cases or not. If it turns out that the results of both premedications differ and possibly a revision of the premedication document is necessary, unblinding and, if necessary, correction of the premedication document takes place.

Furthermore, the time required for the premedication interview is analyzed as well as the correct arrangement of additional examinations. The secondary outcome parameters are collected using the KIS (clinic information system) and PDMS.

As a comparison population with respect to the secondary endpoints, a conventionally premedicated patient collective, whose anonymized data is extracted from the existing PDMS database, is used in the same period. The endpoint of the comparison is the occurrence of postoperative complications corresponding to a clavia-dindo score of ≥ 3. This corresponds to the events of re-intervention, admission to intensive care unit or death.

Expected end of data collection With hospital discharge, the data collection for the individual patient is completed.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81675
    • TU Muenchen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age >= 18 years
• ASA 3 or 4
• elective surgery
• written informed consent

Exclusion Criteria:

• emergency surgery
• patient not being able to give informed consent
• non-german-speaking patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Software first; Patients that are pre-operatively assessed first software-guided and then traditional	Device: Premedication Guide; Software with guidelines recommendations for preoperative assessment
Other: Traditional; Patients that are first pre-operatively assessed in the traditional way and then with aid of the software	Device: Premedication Guide; Software with guidelines recommendations for preoperative assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correct approval for operation	number of patients that were approved correctly for surgery	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	length of hospital stay	30 days
missing examinations	number of examinations that were recommended by the guidelines but not applied to the patient	1 day
unnecessary examinations	number of examinations that were not recommended by the guidelines but nevertheless applied	1 day
mortality	in-hospital mortality	30 days
postoperative complications	postoperative complications assessed by the Clavien-Dindo-Classification (I: no intervention, II: pharmacologic intervention, IIIa:intervention without general anesthesia, IIb: intervention requiring general anesthesia, IV:life-threatening intervention with dysfunction of one organ, IVb: life-threatening intervention with multi-organ dysfunction, V:death	30 days

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Health Information Management, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 38/19 S-SR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No