Clinical Guidelines in Premedication Visit | NCT04843202

Studies
Clinical Guidelines in Premedication Visit

NCT04843202

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Oct 5, 2021Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Non-cardiac Surgery
Adults

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Apr 8, 2021

First Submission Date that Met QC Criteria

Apr 8, 2021

First Posted Date

Apr 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2021

Last Update Posted Date

Oct 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Simone Kagerbauer, Specialist in anesthesiology, Technical University of MunichPrincipal Investigator

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Name	Class
HIM Health Information Management GmbH	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Guideline adherence	Determine the frequency with which individual guideline recommendations on preoperative evaluation are implemented.	June 2018-June2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age<18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Random sample of all patients >18 years of age seen in the premedication outpatient clinic from June 2018 to June 2020. This restriction is made because the guidelines used in this study apply only to adult patients.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Technical University of Munich		Munich		81675	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29708905	Background	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.
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