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AzTrials

TelemedicineTELANESTHNCT04920604

Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation.

A study testing Face-to-face anesthesia consultation and Remote anesthesia consultation in people with Telemedicine and Anesthesia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The anesthesia safety decree made it compulsory in 1994 to carry out a pre-anesthesia consultation before any operative or interventional act. With the inclusion of telemedicine in the Public Health Code then the publication of Addendum 6 in 2018 and finally the derogatory decree in March 2020, it is possible to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Telemedicine, Anesthesia, Consultation, Remote
What is being tested?
Face-to-face anesthesia consultation and Remote anesthesia consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteFrance
Study dates
20 May 2021to 21 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • Patient with scheduled surgical intervention (outpatient or hospitalization) at the Nîmes University Hospital requiring a preoperative anesthesia consultation.
  • Patient with computer equipment at home allowing the use of the Téléo software (computer equipment with web cam, audio and microphone or smartphone).

Who cannot join

  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient who has already had an anesthesia consultation for surgery within the previous 6 months.
  • Emergency or radiology and / or interventional surgery (eg. gastroscopy, biopsy under scanner, etc.).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, Gard, 30029

Other trials in France

About this study

The anesthesia safety decree made it compulsory in 1994 to carry out a pre-anesthesia consultation before any operative or interventional act. With the inclusion of telemedicine in the Public Health Code then the publication of Addendum 6 in 2018 and finally the derogatory decree in March 2020, it is possible to perform and bill for pre-anesthesia consultation via telemedicine.

The consultation is always followed by a pre-anesthetic visit upon admission of the patient the day before or the day of the operation to verify the information recorded during the consultation and the patient's state of health. This identifies elements omitted during the pre-anesthesia consultation (face-to-face or remotely) and reduces the risks of potential postponement.

The study investigators hypothesize that there would be no difference in the quality of the information given, the collection of medical, paramedical and medication elements and the evaluation of the operative risk in anesthesia consultation via teleconsultation versus face-to-face. The critical points are the medication reconciliation of the patient's treatments, the overall assessment of the operative risk and anticipated difficulty of access to the airways (mouth opening: ≥ or <35 mmm).

Being tested
Face-to-face anesthesia consultation, Remote anesthesia consultation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Face-to-face anesthesia consultationOther

    The anesthesia consultation is carried out in person in accordance with the usual management.

  • Remote anesthesia consultationOther

    Anesthesia consultation is carried out in teleconsultation via the "Téléo" web application (audio and video) at the patient's home on a computer or smartphone. This application allows sending and receiving documents identical to those during the face-to-face consultation.

Study groups in NCT04920604
Study groupRoleWhat they receive
TeleconsultationExperimentalNot described
Receives: Other: Remote anesthesia consultation
Control groupActive comparatorNot described
Receives: Other: Face-to-face anesthesia consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Elevated American Society of Anesthesiologists (ASA) score in each group

    Yes/no for if score=3-4

    Measured: anesthesia consultation = 1 week to 3 months after inclusion

  2. Elevated American Society of Anesthesiologists (ASA) score in each group

    Yes/no for if score=3-4

    Measured: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion

  3. Difficulty in accessing airways each group

    Yes/no for mouth opening ≥35 mm

    Measured: anesthesia consultation = 1 week to 3 months after inclusion

  4. Difficulty in accessing airways each group

    Yes/no for mouth opening ≥35 mm

    Measured: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion

  5. Medication conciliation performed during the anesthesia consultation each group

    Yes/no: adaptations of selected therapies: anticoagulants, anti-aggregants, anti-hypertension, antidiabetics

    Measured: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion

  6. Medication conciliation performed during the anesthesia consultation each group

    Yes/no: adaptations of selected therapies: anticoagulants, anti-aggregants, anti-hypertension, antidiabetics

    Measured: anesthesia consultation = 1 week to 3 months after inclusion

  7. Difference between groups in composite score of above outcomes (elevated ASA score, difficulty accessing airways and medication conciliation)

    Difference in number of yes/no answers at anesthesia consultation compared to pre- anesthetic visit

    Measured: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion

  8. Difference between groups in composite score of above outcomes (elevated ASA score, difficulty accessing airways and medication conciliation)

    Difference in number of yes/no answers at anesthesia consultation compared to pre- anesthetic visit

    Measured: anesthesia consultation = 1 week to 3 months after inclusion

Secondary outcomes (14)

  1. Number of canceled surgeries in each group

    Yes/no surgery not performed on the scheduled day and / or postponed > 2 days

    Measured: Day 2 after pre-anesthetic visit

  2. Reason for cancellation of surgery

    Description noted in electronic clinical report form

    Measured: Day 2 after pre-anesthetic visit

  3. Number of delayed surgeries in each group

    Yes/no surgery not performed on the scheduled day and / or postponed ≤ 2 days

    Measured: Day 2 after pre-anesthetic visit

  4. Reason for delayed surgery

    Description noted in electronic clinical report form

    Measured: Day 2 after pre-anesthetic visit

  5. Complication rate in perioperative and immediate postoperative period

    % patients with a complication

    Measured: 2 days post-operatively

  6. Rate of anesthesia consultation rescheduling in each group

    Number of consultations rescheduled

    Measured: 2 days after pre-anesthetic visit

  7. Reason for rescheduling

    Description noted in electronic clinical report form

    Measured: 2 days after pre-anesthetic visit

  8. Global patient satisfaction

    satisfaction on a visual analog scale 0-10

    Measured: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion

  9. Satisfaction on the delivery of the information

    6-item custom questionnaire completed on a Likert 0 - 5 scale for all patients plus 6 questions specific for control group and 7 for intervention group

    Measured: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion

  10. Ecological impact of the consultation in each group

    Carbon impact (CO2 generated) of number of km between the patient's home and the hospital

    Measured: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion

  11. Economic impact of the consultation in each group

    Cost in euros of cost of travel and time at work missed

    Measured: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion

  12. Rate of presence of the usual treatment prescription

    Yes/no

    Measured: During the anesthesia consultation = 1 week to 3 months after inclusion

  13. Rate of presence of the completed health questionnaire

    Yes/no

    Measured: During the anesthesia consultation = 1 week to 3 months after inclusion

  14. Rate of presence of specialist consultation reports less than 1 year old

    Yes/no

    Measured: During the anesthesia consultation = 1 week to 3 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start20 May 2021
  3. Primary completion21 Apr 2022
  4. Study completion21 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04920604
Sponsor's protocol ID
NIMAO/2020-2/EM-01
Other IDs
2021-A00311-40
Acronym
TELANESTH
Status last verified
Dec 2025
First submitted
27 May 2021
Last updated
22 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Morau E, Blanc A, Boisson C, Sawyers T, Lefrant J, Cuvillon P. Telemedicine for Preanesthesia Consultations During the First COVID-19 Lockdown. Telemed J E Health. 2023 Apr;29(4):621-624. doi: 10.1089/tmj.2022.0143. Epub 2022 Jul 26.

    PubMed 35877785

Questions about this trial

What is this clinical trial studying?

A study testing Face-to-face anesthesia consultation and Remote anesthesia consultation in people with Telemedicine and Anesthesia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elevated American Society of Anesthesiologists (ASA) score in each group (time frame: anesthesia consultation = 1 week to 3 months after inclusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04920604, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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