Skip to content

Quality of Preanesthesia Teleconsultation : a Randomized Controlled Trial.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03470896
Acronym
TELECAM
Enrollment
240
Registered
2018-03-20
Start date
2018-05-01
Completion date
2021-05-31
Last updated
2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preanesthesia Consultation

Keywords

preanesthesia teleconsultation, video-conference, ambulatory surgery, telemedicine

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.

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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

One group : preanesthesia teleconsultation / One group : preanesthesia traditional teleconsultation / One sub-group : bis preanesthesia traditional teleconsultation

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Agreement concerning the risk of difficult intubation between preanesthesia consultation and visit.1 day before surgery or baseline (J0 = surgery day)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.

Secondary

MeasureTime frameDescription
Agreement between preanesthesia consultation and visit concerning the evaluation of American Society of Anesthesiologists (ASA) score of the patient1 day before surgery or baseline (J0 = surgery day)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.)
Agreement between preanesthesia consultation and visit concerning correct treatment management.1 day before surgery or baseline (J0 = surgery day)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.)
Agreement between preanesthesia consultation and visit concerning completeness of preoperative workup1 day before surgery or baseline (J0 = surgery day)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.)
Agreement between preanesthesia consultation and visit concerning the risk of difficult mask ventilation1 day before surgery or baseline (J0 = surgery day)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.
Satisfaction of patient1 day before surgery or baseline (J0 = surgery day)Satisfaction of patient, who attended teleconsultation, tested by visual analogue scale : from 0 to 10 (poor to good results) in comparison with traditional consultation
Preoperative anxiety of patient1 day before surgery or baseline (J0 = surgery day)Preoperative anxiety of patient, who attended teleconsultation, tested by amsterdam scale (APAIS), in comparison with traditional consultation
Calculation of a ratio to evaluate the technical viability of generalising preanesthesia teleconsultation1 day before surgery or baseline (J0 = surgery day)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.
Satisfaction of anesthesiologist1 day before surgery or baseline (J0 = surgery day)Satisfaction of anesthesiologist, who realized teleconsultation, tested by visual analogue scale : from 0 to 10 (poor to good results), in comparison with traditional consultation

Contacts

Primary ContactAnaïs ROCHE
anais_2025@hotmail.fr0627523294
Backup ContactYohann BERNARD
y.bernard@chru-nancy.fr0383155272

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026