Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04058769 |
| Other study ID # |
38/19 S-SR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
September 30, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Technical University of Munich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
