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

NCT04920604 | Completed

• 2 other identifiers: NIMAO/2020-2/EM-012021-A00311-40
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Telemedicine; Anesthesia; Consultation, Remote

Outcome Measures

Primary Outcomes (8)

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

  Yes/no for if score=3-4

  anesthesia consultation = 1 week to 3 months after inclusion

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

  Yes/no for if score=3-4

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

• Difficulty in accessing airways each group

  Yes/no for mouth opening ≥35 mm

  anesthesia consultation = 1 week to 3 months after inclusion

• Difficulty in accessing airways each group

  Yes/no for mouth opening ≥35 mm

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

• Medication conciliation performed during the anesthesia consultation each group

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

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

• Medication conciliation performed during the anesthesia consultation each group

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

  anesthesia consultation = 1 week to 3 months after inclusion

• 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

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

• 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

  anesthesia consultation = 1 week to 3 months after inclusion

Secondary Outcomes (14)

• Number of canceled surgeries in each group

  Day 2 after pre-anesthetic visit

• Reason for cancellation of surgery

  Day 2 after pre-anesthetic visit

• Number of delayed surgeries in each group

  Day 2 after pre-anesthetic visit

• Reason for delayed surgery

  Day 2 after pre-anesthetic visit

• Complication rate in perioperative and immediate postoperative period

  2 days post-operatively

Study Arms (2)

Teleconsultation

EXPERIMENTAL

Other: Remote anesthesia consultation

Control group

ACTIVE COMPARATOR

Other: Face-to-face anesthesia consultation

Interventions

Face-to-face anesthesia consultation OTHER

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

Control group

Remote anesthesia consultation OTHER

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.

Teleconsultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 35877785 RESULT

Study Officials

• Estelle Morau

  CHU Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 10, 2021
• Study Start: May 20, 2021
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)