Quality of Preanesthesia Teleconsultation : a Randomized Controlled Trial.

NCT ID: NCT03470896

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preanesthesia Consultation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group : preanesthesia teleconsultation / One group : preanesthesia traditional teleconsultation / One sub-group : bis preanesthesia traditional teleconsultation
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Participant and care provider know the allocation group "teleconsultation" or "traditional consultation".

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

preanesthesia teleconsultation

Intervention Type PROCEDURE

According to his allocated group, patient will have a teleconsultation at home/at work with an anaesthesiologist.

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.

Group Type ACTIVE_COMPARATOR

preanesthesia traditional consultation

Intervention Type PROCEDURE

According to his allocated group, patient will have a traditional consultation with an anaesthesiologist in the surgical center Emile Galle.

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 ".

Group Type OTHER

preanesthesia traditional consultation

Intervention Type PROCEDURE

According to his allocated group, patient will have a traditional consultation with an anaesthesiologist in the surgical center Emile Galle.

Interventions

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preanesthesia teleconsultation

According to his allocated group, patient will have a teleconsultation at home/at work with an anaesthesiologist.

Intervention Type PROCEDURE

preanesthesia traditional consultation

According to his allocated group, patient will have a traditional consultation with an anaesthesiologist in the surgical center Emile Galle.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herve BOUAZIZ, PUPH

Role: PRINCIPAL_INVESTIGATOR

Central HNF

Central Contacts

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Anaïs ROCHE

Role: CONTACT

0627523294

Yohann BERNARD

Role: CONTACT

0383155272

References

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Roche A, Simon M, Bouaziz H, Poussel M, Sirveaux F, Adam I, Delpuech M, Thilly N. Quality of Preanesthesia Teleconsultation: The TELECAM Randomized Controlled Trial. Telemed J E Health. 2024 Aug;30(8):e2300-e2310. doi: 10.1089/tmj.2024.0027. Epub 2024 May 3.

Reference Type DERIVED
PMID: 38700568 (View on PubMed)

Other Identifiers

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2017-A03084-49

Identifier Type: -

Identifier Source: org_study_id

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