Clinical trial NCT03470896: Quality of Preanesthesia Teleconsultation : a Randomized Controlled Trial.
Official title: Quality of Preanesthesia Teleconsultation Versus Preanesthesia Traditional Consultation : a Randomized Controlled Equivalence Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preanesthesia Consultation
Keywords: preanesthesia teleconsultation
video-conference
ambulatory surgery
telemedicine
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group : preanesthesia teleconsultation / One group : preanesthesia traditional teleconsultation / One sub-group : bis preanesthesia traditional teleconsultation
Primary purpose: OTHER

Brief summary: Since the publication of the law " Hôpital, Patients, Santé, Territoire " of 2009 in France, the development of telemedicine is a public health issue. It is also a government priority registered in the government investment plan of 2017-2018.

The quality of preanesthesia teleconsultation at home, through video-conference, has never been tested in practice.The aim of this study is to evaluate the quality of preanesthesia teleconsultations through video-conference, compared with traditional preanesthesia consultations. The quality is established by the assessment of the primary outcome : the risks related to difficult intubation, in patients undergoing ambulatory surgery at the Surgical Center Emile Galle. Our research hypothesis is that there is no difference between the quality of preanesthesia teleconsultations through video-conference, and the quality of traditional preanesthesia consultations. Secondary objectives are to identify satisfaction and preoperative anxiety of patients regarding teleconsultation, to identify satisfaction of practioners regarding teleconsultation, to evaluate the quality (based on the assessment of secondary outcomes) of preanesthesia teleconsultations compared with traditional preanesthesia consultations, and to evaluate the technical viability of generalising preanesthesia teleconsultation.


Eligibility criteria: Inclusion Criteria:

* Patient with social security affiliation.
* Informed consent from patient
* Patient with an ambulatory surgery programmed in the surgical center Emile Galle (CHRU de Nancy)
* Patient with technology equipments, which are compatible with the plateform of video-conference :
* smartphones, touch pads, computer
* web-browser ( chrome or internet explorer)
* Webcam and microphone
* Printer

Exclusion Criteria:

* Patients covered by Articles L. 1121-5 to L. 1121-8, L1122-2 and L. 1122-1-2 of the french public health code. (Persons especially protected by Act)
* Patients refusing to participate to the study, or refusing the randomization for the group allocation.
* Preanesthesia consultation for a programmed surgery in an hospital other than the surgical center of Emile Galle.

Primary outcomes:
measure: Agreement concerning the risk of difficult intubation between preanesthesia consultation and visit.
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
Secondary outcomes:
measure: Agreement between preanesthesia consultation and visit concerning the risk of difficult mask ventilation
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
measure: Agreement between preanesthesia consultation and visit concerning the evaluation of "American Society of Anesthesiologists" (ASA) score of the patient
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
measure: Agreement between preanesthesia consultation and visit concerning correct treatment management.
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
measure: Agreement between preanesthesia consultation and visit concerning completeness of preoperative workup
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
measure: Satisfaction of anesthesiologist
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
measure: Satisfaction of patient
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
measure: Preoperative anxiety of patient
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
measure: Calculation of a ratio to evaluate the technical viability of generalising preanesthesia teleconsultation
timeFrame: 1 day before surgery or baseline (J0 = surgery day)
Other outcomes:
Locations:
Study officials:
affiliation: Central HNF
name: Herve BOUAZIZ, PUPH
role: PRINCIPAL_INVESTIGATOR
References: