CClinicalTrials.gg
Status unknownNCT03470896TELECAMUpdated Mar 20, 2018

Quality of Preanesthesia Teleconsultation : a Randomized Controlled Trial.

An interventional study of preanesthesia teleconsultation and preanesthesia traditional consultation in Preanesthesia Consultation, sponsored by Central Hospital, Nancy, France. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-20.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Preanesthesia Consultation

Keywords

  • preanesthesia teleconsultation
  • video-conference
  • ambulatory surgery
  • telemedicine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Procedurepreanesthesia teleconsultation

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

  • Procedurepreanesthesia traditional consultation

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

Secondary outcomes

  1. 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.

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

  2. 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.)

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

  3. 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.)

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

  4. 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.)

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

  5. 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

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

  6. 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

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

  7. Preoperative anxiety of patient

    Preoperative anxiety of patient, who attended teleconsultation, tested by amsterdam scale (APAIS), in comparison with traditional consultation

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

  8. 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.

    Time frame: 1 day before surgery or baseline (J0 = surgery day)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03470896
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Mar 20, 2018
Start date
May 1, 2018 (estimated)
Primary completion
May 2021 (estimated)
Completion
May 2021 (estimated)
Last update
Mar 20, 2018

Study contacts

Anaïs ROCHE
Contact
anais_2025@hotmail.fr
0627523294
Yohann BERNARD
Contact
y.bernard@chru-nancy.fr
0383155272
Herve BOUAZIZ, PUPH
principal investigator · Central HNF

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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