Non-cardiac SurgeryNCT04843202
Clinical Guidelines in Premedication Visit
An observational study of Non-cardiac Surgery and Adults, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cardiac Surgery, Adults
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Patients seen in the outpatient clinic between June 2018 and June 2020
Who cannot join
- age<18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining Guideline Adherence During the Premedication Visit
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.
Read the 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.
- Conditions
- Non-cardiac Surgery, Adults
- Keywords
- premedication, guidelines, software
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline adherence
Determine the frequency with which individual guideline recommendations on preoperative evaluation are implemented.
Measured: June 2018-June2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Jun 2018
- Primary completion1 Jun 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- HIM Health Information Management GmbH
- Responsible party
- Principal investigator, Simone Kagerbauer, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843202
- Sponsor's protocol ID
- 450/20 S-EB
- Status last verified
- Oct 2021
- First submitted
- 8 Apr 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available on request
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.
PubMed 29708905Kagerbauer SM, Wissler J, Blobner M, Biegert F, Andonov DI, Schneider G, Podtschaske AH, Ulm B, Jungwirth B. Anaesthesiologists' guideline adherence in pre-operative evaluation: a retrospective observational study. Perioper Med (Lond). 2024 Jun 28;13(1):64. doi: 10.1186/s13741-024-00424-5.
PubMed 38943163
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Guideline Adherence During the Premedication Visit
- ClinicalTrials.gov ID
- NCT04843202
- Acronym / sponsor ID
- 450/20 S-EB
- Conditions
- Non-cardiac Surgery, Adults
- Keywords
- premedication, guidelines, software
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- HIM Health Information Management GmbH
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Patients seen in the outpatient clinic between June 2018 and June 2020
Key exclusion criteria (1 listed)
- age<18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Guideline adherence
Time frame: June 2018-June2020
Determine the frequency with which individual guideline recommendations on preoperative evaluation are implemented.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 29708905De 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.
- Derived from this study: PubMed 38943163Kagerbauer SM, Wissler J, Blobner M, Biegert F, Andonov DI, Schneider G, Podtschaske AH, Ulm B, Jungwirth B. Anaesthesiologists' guideline adherence in pre-operative evaluation: a retrospective observational study. Perioper Med (Lond). 2024 Jun 28;13(1):64. doi: 10.1186/s13741-024-00424-5.
- Individual participant dataSharing planned: Undecided. Data will be made available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-cardiac Surgery and Adults, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline adherence (time frame: June 2018-June2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843202, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.