- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04920604
Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation. (TELANESTH)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30029
- Centre Hospitalier Universitaire de Nīmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
|
The anesthesia consultation is carried out in person in accordance with the usual management.
|
|
Experimental: Teleconsultation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Elevated American Society of Anesthesiologists (ASA) score in each group
Time Frame: anesthesia consultation = 1 week to 3 months after inclusion
|
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
Time Frame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
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
Time Frame: anesthesia consultation = 1 week to 3 months after inclusion
|
Yes/no for mouth opening ≥35 mm
|
anesthesia consultation = 1 week to 3 months after inclusion
|
|
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
|
pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
|
Medication conciliation performed during the anesthesia consultation each group
Time Frame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
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
Time Frame: anesthesia consultation = 1 week to 3 months after inclusion
|
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)
Time Frame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
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)
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
|
anesthesia consultation = 1 week to 3 months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of canceled surgeries in each group
Time Frame: Day 2 after pre-anesthetic visit
|
Yes/no surgery not performed on the scheduled day and / or postponed > 2 days
|
Day 2 after pre-anesthetic visit
|
|
Reason for cancellation of surgery
Time Frame: Day 2 after pre-anesthetic visit
|
Description noted in electronic clinical report form
|
Day 2 after pre-anesthetic visit
|
|
Number of delayed surgeries in each group
Time Frame: Day 2 after pre-anesthetic visit
|
Yes/no surgery not performed on the scheduled day and / or postponed ≤ 2 days
|
Day 2 after pre-anesthetic visit
|
|
Reason for delayed surgery
Time Frame: Day 2 after pre-anesthetic visit
|
Description noted in electronic clinical report form
|
Day 2 after pre-anesthetic visit
|
|
Complication rate in perioperative and immediate postoperative period
Time Frame: 2 days post-operatively
|
% patients with a complication
|
2 days post-operatively
|
|
Rate of anesthesia consultation rescheduling in each group
Time Frame: 2 days after pre-anesthetic visit
|
Number of consultations rescheduled
|
2 days after pre-anesthetic visit
|
|
Reason for rescheduling
Time Frame: 2 days after pre-anesthetic visit
|
Description noted in electronic clinical report form
|
2 days after pre-anesthetic visit
|
|
Global patient satisfaction
Time Frame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
satisfaction on a visual analog scale 0-10
|
pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
|
Satisfaction on the delivery of the information
Time Frame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
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
|
pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
|
Ecological impact of the consultation in each group
Time Frame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
Carbon impact (CO2 generated) of number of km between the patient's home and the hospital
|
pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
|
Economic impact of the consultation in each group
Time Frame: pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
Cost in euros of cost of travel and time at work missed
|
pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
|
|
Rate of presence of the usual treatment prescription
Time Frame: During the anesthesia consultation = 1 week to 3 months after inclusion
|
Yes/no
|
During the anesthesia consultation = 1 week to 3 months after inclusion
|
|
Rate of presence of the completed health questionnaire
Time Frame: During the anesthesia consultation = 1 week to 3 months after inclusion
|
Yes/no
|
During the anesthesia consultation = 1 week to 3 months after inclusion
|
|
Rate of presence of specialist consultation reports less than 1 year old
Time Frame: During the anesthesia consultation = 1 week to 3 months after inclusion
|
Yes/no
|
During the anesthesia consultation = 1 week to 3 months after inclusion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Estelle Morau, CHU Nîmes
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIMAO/2020-2/EM-01
- 2021-A00311-40 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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