Clinical Guidelines in Premedication Visit

Adults Clinical Trial

Official title:

Determining Guideline Adherence During the Premedication Visit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843202
• Other study ID #: 450/20 S-EB
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2021
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• age<18

Related Conditions & MeSH terms

• Adults
• Non-cardiac Surgery

Locations

Country	Name	City	State
Germany	Technical University of Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	HIM Health Information Management GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guideline adherence	Determine the frequency with which individual guideline recommendations on preoperative evaluation are implemented.	June 2018-June2020