Validation of Telemedicine Pre-anesthesia Consultation in Low-risk Anesthetic Patients Undergoing Ambulatory Surgery (ANESTHADOM)

March 27, 2020 updated by: University Hospital, Grenoble
The purpose of this study is to validate the teleconsultation of anesthesia in anesthetic low risk patients and undergoing outpatient surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Anesthesia consultation is a necessary and obligatory step in the process of anesthesia. Telemedicine anesthesia consultation (TCAD) experiments have been successfully conducted in the United States, demonstrating the technical feasibility and medical relevance of the approach. In partnership with the Rhône-Alpes Regional Health Agency, an Telemedicine anesthesia consultation will be set up at the University Hospital Grenoble for low-risk anesthetic and surgical patients via a telemedicine platform accessible to patients' homes. Avoiding transport, unclog consultations in hospitals, and avoiding absences from work for traditional consultations are some of the advantages of this new method of consultation. This project involves assessing the feasibility, safety, and costs associated with home anesthesia teleconsultation for patients requiring outpatient surgery.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for ambulatory surgery with anesthesia procedures
  • Patients with American Society of Anesthesiologists score 1 or 2.
  • Patients with visual and auditory acuity, language proficiency.
  • Non-urgent surgery
  • Affiliation to the French Social Security

Exclusion Criteria:

  • patient with American Society of Anesthesiologists score 2 and complex treatments
  • Complex surgical procedure
  • Patient taking anticoagulant and / or antiplatelet treatments
  • Patient having a serious problem during a previous surgery
  • Pregnant woman
  • Patient under guardianship or deprivation of liberty by judicial decision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TCAD (telemedicine anesthesia consultation)
Patients having a telemedicine anesthesia consultation
Other: TCAD (telemedicine anesthesia consultation)
Patients in the TCAD (telemedicine anesthesia consultation) group, arrange their bookings on a website and realise their anesthesia consultation from a platform from home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of anesthesia teleconsultation in low-risk anesthetic patients undergoing outpatient surgery
Time Frame: 24 hours post surgery
Patients rate with performed surgery following a successful telemedicine anesthesia consultation without cancellation or postponement of surgery
24 hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthesia teleconsultation failure rate for technical reasons
Time Frame: up to 1 hour post anesthesia teleconsultation outset
Rate of patients who did not benefit from anesthesia teleconsultation for technical reasons
up to 1 hour post anesthesia teleconsultation outset
Cancellation or postponement surgery rate
Time Frame: 24 hours post surgery
Patients rate
24 hours post surgery
Patient rate, seen in teleconsultation, secondarily oriented towards a conventional consultation
Time Frame: 24 hours post surgery
Patients rate
24 hours post surgery
Extension of the ambulatory stay rate
Time Frame: 24 hours post surgery
Patients rate
24 hours post surgery
Readmitted patients rate
Time Frame: 24 hours post surgery
Rate of readmitted patients related with surgery and assigned to the teleconsultation
24 hours post surgery
Patient satisfaction with anesthesia teleconsultation
Time Frame: at 7 days post hospital discharge
Global satisfaction level (regarding the sound and picture quality, respect of confidentiality and privacy, recommend or choose teleconsultation for the next anesthesia consultation) using Numerical Rating Scale from 0 to 10, 0 : extremely unsatisfied, 10= extremely satisfied.
at 7 days post hospital discharge
Physician satisfaction with anesthesia teleconsultation
Time Frame: up to 1 hour post anesthesia teleconsultation outset
Global satisfaction level (regarding the sound and picture quality, respect of confidentiality and privacy, clinical observations collection quality, recommend teleconsultation for the next anesthesia consultation) using Numerical Rating Scale from 0 to 10, 0 : extremely unsatisfied, 10= extremely satisfied.
up to 1 hour post anesthesia teleconsultation outset
Cost of transportation from home to hospital
Time Frame: at 7 days post hospital discharge
Cost ( euros)
at 7 days post hospital discharge
Rate of transportation carbon footprint saved using anesthesia teleconsultation
Time Frame: at 7 days post hospital discharge
co2 equivalent
at 7 days post hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Agence Régionale de Santé Rhône-Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (ACTUAL)

July 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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