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

Anesthesia Clinical Trial

— TELANESTH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920604
• Other study ID #: NIMAO/2020-2/EM-01
• Status: Recruiting
• Start date: May 20, 2021
• Est. completion date: February 2022

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Estelle Morau
• Phone: 04.66.68.30.50
• Email: estelle.morau[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Anesthesia
• Telemedicine

Intervention

Other:
• Face-to-face anesthesia consultation
The anesthesia consultation is carried out in person in accordance with the usual management.
• Remote anesthesia consultation
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Difficulty in accessing airways each group	Yes/no for mouth opening =35 mm	anesthesia consultation = 1 week to 3 months after inclusion
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of canceled surgeries in each group	Yes/no surgery not performed on the scheduled day and / or postponed > 2 days	Day 2 after pre-anesthetic visit
Secondary	Reason for cancellation of surgery	Description noted in electronic clinical report form	Day 2 after pre-anesthetic visit
Secondary	Number of delayed surgeries in each group	Yes/no surgery not performed on the scheduled day and / or postponed = 2 days	Day 2 after pre-anesthetic visit
Secondary	Reason for delayed surgery	Description noted in electronic clinical report form	Day 2 after pre-anesthetic visit
Secondary	Complication rate in perioperative and immediate postoperative period	% patients with a complication	2 days post-operatively
Secondary	Rate of anesthesia consultation rescheduling in each group	Number of consultations rescheduled	2 days after pre-anesthetic visit
Secondary	Reason for rescheduling	Description noted in electronic clinical report form	2 days after pre-anesthetic visit
Secondary	Global patient satisfaction	satisfaction on a visual analog scale 0-10	pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
Secondary	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	pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
Secondary	Ecological impact of the consultation in each group	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
Secondary	Economic impact of the consultation in each group	Cost in euros of cost of travel and time at work missed	pre-anesthetic visit = 9 days to 3 months+7 days after inclusion
Secondary	Rate of presence of the usual treatment prescription	Yes/no	During the anesthesia consultation = 1 week to 3 months after inclusion
Secondary	Rate of presence of the completed health questionnaire	Yes/no	During the anesthesia consultation = 1 week to 3 months after inclusion
Secondary	Rate of presence of specialist consultation reports less than 1 year old	Yes/no	During the anesthesia consultation = 1 week to 3 months after inclusion