Clinical Guidelines in Premedication Visit

Sponsor

Technische Universität München (Other)

Overall Status

Completed

CT.gov ID

NCT04843202

Collaborator

HIM Health Information Management GmbH (Other)

2,000

Enrollment

Location

Actual Duration (Months)

51.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the frequency with which individual guideline recommendations on preoperative evaluation of patients scheduled for non-cardiac surgery are implemented as well as identifying the guidelines that are most frequently violated.

Condition or Disease	Intervention/Treatment	Phase
Non-cardiac Surgery Adults

Detailed Description

This study is a monocentric retrospective analysis. Data are extracted from the electronic premedication protocol (premedication patient data management system, PDMS). A total of 2000 adult patients are randomly selected who were seen in the premedication outpatient clinic of Klinikum rechts der Isar between June 2018 and June 2020. The information from the premedication questionnaire will be transferred to a new premedication module. The new premedication software then outputs the appropriate guideline recommendations that would have been applicable in the particular case. Using a logic stored in this system, the current guideline recommendations of the European Society of Anaesthesiology (ESA) (De Hert, Staender et al. 2018) and the recommendations of the German Society for Anesthesiology and Intensive Care Medicine (DGAI) (Geldner 2017) that apply to the respective case are pointed out on the basis of the patient data entered, for example the recommendation to discontinue or change medication or the order of additional examinations such as pulmonary function testing or echocardiography.

By comparison with the old premedication sheet, it is determined which guideline recommendations were followed and which were not. The respective guideline recommendations and their compliance or non-compliance are transferred to a table for further evaluation. A random sample of 2000 patients will be studied.

Guideline adherence to each recommendation is determined, as well as the possible organizational reasons for not following them.

Study Design

Study Type:

Observational

Actual Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Determining Guideline Adherence During the Premedication Visit

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Sep 1, 2021

Outcome Measures

Primary Outcome Measures

Guideline adherence [June 2018-June2020]
Determine the frequency with which individual guideline recommendations on preoperative evaluation are implemented.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients seen in the outpatient clinic between June 2018 and June 2020

Exclusion Criteria:

age<18

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Technical University of Munich	Munich		Germany	81675

Sponsors and Collaborators

Technische Universität München
HIM Health Information Management GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

De Hert S, Staender S, Fritsch G, Hinkelbein J, Afshari A, Bettelli G, Bock M, Chew MS, Coburn M, De Robertis E, Drinhaus H, Feldheiser A, Geldner G, Lahner D, Macas A, Neuhaus C, Rauch S, Santos-Ampuero MA, Solca M, Tanha N, Traskaite V, Wagner G, Wappler F. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2018 Jun;35(6):407-465. doi: 10.1097/EJA.0000000000000817.

Responsible Party:

Simone Kagerbauer, Specialist in anesthesiology, Technische Universität München

ClinicalTrials.gov Identifier:

NCT04843202

Other Study ID Numbers:

450/20 S-EB

First Posted:

Apr 13, 2021

Last Update Posted:

Oct 5, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Simone Kagerbauer, Specialist in anesthesiology, Technische Universität München

premedication

guidelines

software

Study Results

No Results Posted as of Oct 5, 2021