Skip to main content
Clinical Trials/NCT04920604
NCT04920604
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country172 target enrollmentMay 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Telemedicine
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
172
Locations
1
Primary Endpoint
Elevated American Society of Anesthesiologists (ASA) score in each group
Status
Completed
Last Updated
4 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 20, 2021
End Date
April 21, 2022
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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.).

Outcomes

Primary Outcomes

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

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

Yes/no for if score=3-4

Difficulty in accessing airways each group

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

Yes/no for mouth opening ≥35 mm

Medication conciliation performed during the anesthesia consultation each group

Time Frame: anesthesia consultation = 1 week to 3 months after inclusion

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

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

Time Frame: anesthesia consultation = 1 week to 3 months after inclusion

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

Secondary Outcomes

  • Ecological impact of the consultation in each group(pre-anesthetic visit = 9 days to 3 months+7 days after inclusion)
  • Economic impact of the consultation in each group(pre-anesthetic visit = 9 days to 3 months+7 days after inclusion)
  • Rate of presence of the usual treatment prescription(During the anesthesia consultation = 1 week to 3 months after inclusion)
  • Rate of presence of the completed health questionnaire(During the anesthesia consultation = 1 week to 3 months after inclusion)
  • Reason for cancellation of surgery(Day 2 after pre-anesthetic visit)
  • Number of canceled surgeries in each group(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)
  • Global patient satisfaction(pre-anesthetic visit = 9 days to 3 months+7 days after inclusion)
  • Rate of anesthesia consultation rescheduling in each group(2 days after pre-anesthetic visit)
  • Reason for rescheduling(2 days after pre-anesthetic visit)
  • Satisfaction on the delivery of the information(pre-anesthetic visit = 9 days to 3 months+7 days after inclusion)
  • Rate of presence of specialist consultation reports less than 1 year old(During the anesthesia consultation = 1 week to 3 months after inclusion)

Study Sites (1)

Loading locations...

Similar Trials