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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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