Clinical trial NCT04518514: Telemedical Risk Assessment and Preoperative Evaluation (TAPE)
Official title: Telemedical Risk Assessment and Preoperative Evaluation for Anesthesia During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Undergoing Elective Surgery With Anesthesia
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Docs in Clouds Telecare GmbH
First posted: 2020-08-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the feasibility, patient satisfaction and time saving of a telemedical risk assessment and preoperative evaluation for anesthesia.

Detailed description: The preanesthesia evaluation and risk assessment is conducted by an anesthesiologist prior to elective surgery. The physician assesses the patient´s medical records and specifies the individual preoperative procedure in order to minimize the perioperative risks. The on-site meeting is often connected with extended travel time and during the COVID-19 pandemic also with an increased infection risk for the patient. This project was initiated to reduce time efforts on patient site and to reduce possible infection risks. The TAPE-software turns every patients home into a remote facility allowing the physician to conduct the preanesthesia evaluation over distance.

Eligibility criteria: Inclusion Criteria:

* ≥18 years
* estimated ASA I/II classification based on the American Society of Anesthesiologists (ASA) classification
* elective surgery
* surgery at least 14 days in the future
* patient access to a Windows-10-based personal computer with webcam

Exclusion Criteria:

* language or cognitive barriers (e.g. dementia, laryngectomy...)
* high risk surgeries with need of postoperative ICU stay
* acute infection with required auscultation

Primary outcomes:
measure: Feasibility (as defined below) of telemedical risk assessment and preoperative evaluation in anesthesiology as assessed by a questionnaire.
timeFrame: 6 months
measure: Patient acceptance of a telemedical preanesthesia evaluation as assessed by a questionnaire.
timeFrame: 6 months
measure: Patient satisfaction with a telemedical preanesthesia evaluation as assessed by a questionnaire.
timeFrame: 6 months
measure: Time saving for the patient
timeFrame: 6 months
measure: Time saving for the physician
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University Hospital
Study officials:
affiliation: RWTH Aachen University Hospital
name: Andreas Follmann, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: RWTH Aachen University Hospital
name: Jan Wienhold, cand. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wienhold J, Mosch L, Rossaint R, Kemper I, Derwall M, Czaplik M, Follmann A. Teleconsultation for preoperative evaluation during the coronavirus disease 2019 pandemic: A technical and medical feasibility study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1284-1292. doi: 10.1097/EJA.0000000000001616.