Clinical trial NCT04920604: Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation.
Official title: Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Telemedicine
Anesthesia
Consultation, Remote
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with outpatient or hospilization programmed surgery requring a unique pre-anesthesia consultation at the CHU Nîmes.

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).


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: Elevated American Society of Anesthesiologists (ASA) score in each group
timeFrame: anesthesia consultation = 1 week to 3 months after inclusion
measure: Elevated American Society of Anesthesiologists (ASA) score in each group
timeFrame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
measure: Difficulty in accessing airways each group
timeFrame: anesthesia consultation = 1 week to 3 months after inclusion
measure: Difficulty in accessing airways each group
timeFrame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
measure: Medication conciliation performed during the anesthesia consultation each group
timeFrame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
measure: Medication conciliation performed during the anesthesia consultation each group
timeFrame: anesthesia consultation = 1 week to 3 months after inclusion
measure: Difference between groups in composite score of above outcomes (elevated ASA score, difficulty accessing airways and medication conciliation)
timeFrame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
measure: Difference between groups in composite score of above outcomes (elevated ASA score, difficulty accessing airways and medication conciliation)
timeFrame: anesthesia consultation = 1 week to 3 months after inclusion
Secondary outcomes:
measure: Number of canceled surgeries in each group
timeFrame: Day 2 after pre-anesthetic visit
measure: Reason for cancellation of surgery
timeFrame: Day 2 after pre-anesthetic visit
measure: Number of delayed surgeries in each group
timeFrame: Day 2 after pre-anesthetic visit
measure: Reason for delayed surgery
timeFrame: Day 2 after pre-anesthetic visit
measure: Complication rate in perioperative and immediate postoperative period
timeFrame: 2 days post-operatively
measure: Rate of anesthesia consultation rescheduling in each group
timeFrame: 2 days after pre-anesthetic visit
measure: Reason for rescheduling
timeFrame: 2 days after pre-anesthetic visit
measure: Global patient satisfaction
timeFrame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
measure: Satisfaction on the delivery of the information
timeFrame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
measure: Ecological impact of the consultation in each group
timeFrame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
measure: Economic impact of the consultation in each group
timeFrame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
measure: Rate of presence of the usual treatment prescription
timeFrame: During the anesthesia consultation = 1 week to 3 months after inclusion
measure: Rate of presence of the completed health questionnaire
timeFrame: During the anesthesia consultation = 1 week to 3 months after inclusion
measure: Rate of presence of specialist consultation reports less than 1 year old
timeFrame: During the anesthesia consultation = 1 week to 3 months after inclusion
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: CHU Nîmes
name: Estelle Morau
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.