Telemedical Risk Assessment and Preoperative Evaluation (TAPE)

Telemedical Risk Assessment and Preoperative Evaluation for Anesthesia During the COVID-19 Pandemic

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.

Study Overview

• Status: Unknown
• Conditions: Patients Undergoing Elective Surgery With Anesthesia
• Intervention / Treatment: Device: TAPE-Software

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • RWTH Aachen University Hospital
    • Contact: Andreas Follmann, Dr.; Phone Number: 0049 2418036219; Email: afollmann@ukaachen.de
    • Contact: Jan Wienhold, cand. med.; Phone Number: 0049 2418036923; Email: jwienhold@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative evaluation and risk assessment via telemedicine	Device: TAPE-Software; Telemedical Risk Assessment and Preoperative Evaluation prior to anaesthesia via personal computer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (as defined below) of telemedical risk assessment and preoperative evaluation in anesthesiology as assessed by a questionnaire.	We focus on the feasibility of a telemedical risk assessment and preoperative evaluation in anesthesiology. We defined feasibility in our scenario as: establishment of a video-audio-connection possible; complete assessment of the patients medical records possible; assessment of the individual perioperative risk possible; physician is put into the position to explain planned procedures and related risks; digital documentation possible; physician is put into the position to answer patient questions; physician can acquire all necessary information; digital signature on both sides possible Those criteria will be assessed by our questionnaires. After preanesthesia evaluation the patient as well as the physician are asked to answer our online questionnaire (two different ones).	6 months
Patient acceptance of a telemedical preanesthesia evaluation as assessed by a questionnaire.	After preanesthesia evaluation the patient is asked to answer our online questionnaire. The questionnaire is partly based on a previously published study (Follmann et al., Technical Support by Smart Glasses During a Mass Casualty Incident: A Randomized Controlled Simulation Trial on Technically Assisted Triage and Telemedical App Use in Disaster Medicine, J Med Internet Res 2019;21(1):e11939).	6 months
Patient satisfaction with a telemedical preanesthesia evaluation as assessed by a questionnaire.	We aim to investigate patient satisfaction of a telemedical risk assessment and preoperative evaluation in anesthesiology prior to elective surgery. After preanesthesia evaluation the patient is asked to answer our online questionnaire. The questionnaire is partly based on a previously published study (Follmann et al., Technical Support by Smart Glasses During a Mass Casualty Incident: A Randomized Controlled Simulation Trial on Technically Assisted Triage and Telemedical App Use in Disaster Medicine, J Med Internet Res 2019;21(1):e11939).	6 months
Time saving for the patient	We quantify time saving on patient site due to the fact that patients do not have to travel to the hospital anymore.	6 months
Time saving for the physician	On physician site we investigate possible time saving due to the implementation of the investigator's software.	6 months
Adverse events	Number of patients in whom telemedical preanesthesia evaluation lead to adverse events such as postponed surgery and adverse events during surgery which are caused by the preanesthesia evaluation.	6 months

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Collaborators: Docs in Clouds Telecare GmbH
• Investigators: Principal Investigator: Andreas Follmann, Dr., RWTH Aachen University Hospital; Principal Investigator: Jan Wienhold, cand. med., RWTH Aachen University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 19-174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No