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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04518514
Other study ID # 19-174
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 20, 2020
Est. completion date November 30, 2020

Study information

Verified date August 2020
Source RWTH Aachen University
Contact Andreas Follmann, Dr.
Phone 0049 0241 8036219
Email afollmann@ukaachen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 30, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Patients Undergoing Elective Surgery With Anesthesia

Intervention

Device:
TAPE-Software
Telemedical Risk Assessment and Preoperative Evaluation prior to anaesthesia via personal computer

Locations

Country Name City State
Germany RWTH Aachen University Hospital Aachen

Sponsors (2)

Lead Sponsor Collaborator
RWTH Aachen University Docs in Clouds Telecare GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary Time saving for the physician On physician site we investigate possible time saving due to the implementation of the investigator's software. 6 months
Primary 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