Quality of Preanesthesia Teleconsultation : a Randomized Controlled Trial. (TELECAM)

Quality of Preanesthesia Teleconsultation Versus Preanesthesia Traditional Consultation : a Randomized Controlled Equivalence Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Preanesthesia Consultation
• Intervention / Treatment: Procedure: preanesthesia teleconsultation; Procedure: preanesthesia traditional consultation

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Preanesthesia teleconsultation; Preanesthesia teleconsultation through video-conference, between an anesthesiologist of the surgical center Emile Galle, in a medical consulting room in the surgical center Emile Galle, and a patient at home or at work. The patient must be in a quiet area, which allows the confidential medical contact.	Procedure: preanesthesia teleconsultation; According to his allocated group, patient will have a teleconsultation at home/at work with an anaesthesiologist.
ACTIVE_COMPARATOR: Preanesthesia traditional consultation; Preanesthesia traditional consultation between an anesthesiologist of the surgical center Emile Galle, and a patient, in a medical consulting room in the surgical center Emile Galle.	Procedure: preanesthesia traditional consultation; According to his allocated group, patient will have a traditional consultation with an anaesthesiologist in the surgical center Emile Galle.
OTHER: Bis traditional consultation; If a patient, in the group " preanesthesia teleconsultation " cannot realized his teleconsultation because of technical problem, he will be assigned on the sub group " bis traditional preanesthesia consultation ".	Procedure: preanesthesia traditional consultation; According to his allocated group, patient will have a traditional consultation with an anaesthesiologist in the surgical center Emile Galle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement concerning the risk of difficult intubation between preanesthesia consultation and visit.	The quality of a preanesthesia consultation (teleconsultations or traditional consultations) is considered to be correct when the result (presence or lack of difficult intubation risks) is consistent with the result of the preanesthesia visit (before surgery.) If yes from 2 of the 4 following propositions about predictable intubation difficulty ( mallampi score > II (yes/no), previous difficult intubation (yes/no), oral opening <30mm (yes/no), distance thyro-mentonnière < 65mm. (yes/no)), the predictable intubation will be difficult.	1 day before surgery or baseline (J0 = surgery day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between preanesthesia consultation and visit concerning the risk of difficult mask ventilation	The quality of a preanesthesia consultation (teleconsultations or traditional consultations) is considered to be correct when the result (presence or lack of difficult mask ventilation risks) is consistent with the result of the preanesthesia visit (before surgery.) If yes from 2 of the 4 following propositions about predictable mask ventilation difficulty ( patient with a barbe (yes/no), BMI>26 kg/m2 (yes/no), edentulous patient (yes/no), an age > 55 years old (yes/no)), snoring (yes/no), the predictable mask ventilation will be difficult.	1 day before surgery or baseline (J0 = surgery day)
Agreement between preanesthesia consultation and visit concerning the evaluation of "American Society of Anesthesiologists" (ASA) score of the patient	The quality of a preanesthesia consultation (teleconsultations or traditional consultations) is considered to be correct when the result (ASA score of the patient) is consistent with the result of the preanesthesia visit (before surgery.)	1 day before surgery or baseline (J0 = surgery day)
Agreement between preanesthesia consultation and visit concerning correct treatment management.	The quality of a preanesthesia consultation (teleconsultations or traditional consultations) is considered to be correct when the result (treatment management : interruption, continuation, relay) is consistent with the result of the preanesthesia visit (before surgery.)	1 day before surgery or baseline (J0 = surgery day)
Agreement between preanesthesia consultation and visit concerning completeness of preoperative workup	The quality of a preanesthesia consultation (teleconsultations or traditional consultations) is considered to be correct when the result (preoperative workup : complete blood count (CBC) with platelet or/and coagulation factors or/and ionograms or/and blood group, or/and consultation with a specialist physician ) is consistent with the result of the preanesthesia visit (before surgery.)	1 day before surgery or baseline (J0 = surgery day)
Satisfaction of anesthesiologist	Satisfaction of anesthesiologist, who realized teleconsultation, tested by visual analogue scale : from 0 to 10 (poor to good results), in comparison with traditional consultation	1 day before surgery or baseline (J0 = surgery day)
Satisfaction of patient	Satisfaction of patient, who attended teleconsultation, tested by visual analogue scale : from 0 to 10 (poor to good results) in comparison with traditional consultation	1 day before surgery or baseline (J0 = surgery day)
Preoperative anxiety of patient	Preoperative anxiety of patient, who attended teleconsultation, tested by amsterdam scale (APAIS), in comparison with traditional consultation	1 day before surgery or baseline (J0 = surgery day)
Calculation of a ratio to evaluate the technical viability of generalising preanesthesia teleconsultation	evaluate the technical viability of generalising preanesthesia teleconsultation, with calculation of ratio : number of randomized patients in group " preanesthesia teleconsultation ", who finally get a teleconsultation / number of randomized patients in group " preanesthesia teleconsultation. " The higher the ratio, the higher the teleconsultation can be considered as a generalisable care practice.	1 day before surgery or baseline (J0 = surgery day)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Herve BOUAZIZ, PUPH, Central HNF

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (ACTUAL): March 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: telemedicine; ambulatory surgery; preanesthesia teleconsultation; video-conference
• Other Study ID Numbers: 2017-A03084-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No