Preanesthesia ConsultationTELECAMNCT03470896
Quality of Preanesthesia Teleconsultation : a Randomized Controlled Trial.
A study testing preanesthesia teleconsultation and preanesthesia traditional consultation in people with Preanesthesia Consultation, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preanesthesia Consultation
- What is being tested?
- preanesthesia teleconsultation and preanesthesia traditional consultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Preanesthesia Consultation
- Being tested
- preanesthesia teleconsultation, preanesthesia traditional consultation
- Keywords
- preanesthesia teleconsultation, video-conference, ambulatory surgery, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preanesthesia teleconsultationProcedure or surgery
According to his allocated group, patient will have a teleconsultation at home/at work with an anaesthesiologist.
preanesthesia traditional consultationProcedure or surgery
According to his allocated group, patient will have a traditional consultation with an anaesthesiologist in the surgical center Emile Galle.
| Study group | Role | What they receive |
|---|---|---|
| Preanesthesia teleconsultation | Active comparator | 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. Receives: Procedure: preanesthesia teleconsultation |
| Preanesthesia traditional consultation | Active comparator | 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. Receives: Procedure: preanesthesia traditional consultation |
| Bis traditional consultation | Other | 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 ". Receives: Procedure: preanesthesia traditional consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day before surgery or baseline (J0 = surgery day)
Secondary outcomes (8)
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.
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 day before surgery or baseline (J0 = surgery day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 May 2018 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preanesthesia ConsultationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group : preanesthesia teleconsultation / One group : preanesthesia traditional teleconsultation / One sub-group : bis preanesthesia traditional teleconsultation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herve BOUAZIZ, PUPH, Principal investigator, Central HNF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470896
- Sponsor's protocol ID
- 2017-A03084-49
- Acronym
- TELECAM
- Status last verified
- Jan 2018
- First submitted
- 8 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38700568
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Preanesthesia Teleconsultation Versus Preanesthesia Traditional Consultation : a Randomized Controlled Equivalence Trial.
- ClinicalTrials.gov ID
- NCT03470896
- Acronym / sponsor ID
- TELECAM / 2017-A03084-49
- Conditions
- Preanesthesia Consultation
- Keywords
- preanesthesia teleconsultation, video-conference, ambulatory surgery, telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- One group : preanesthesia teleconsultation / One group : preanesthesia traditional teleconsultation / One sub-group : bis preanesthesia traditional teleconsultation
| Arm | Type | Receives |
|---|---|---|
| Preanesthesia teleconsultation | Active comparator | Procedure: preanesthesia teleconsultationPreanesthesia 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. |
| Preanesthesia traditional consultation | Active comparator | Procedure: preanesthesia traditional consultationPreanesthesia 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. |
| Bis traditional consultation | Other | Procedure: preanesthesia traditional consultationIf 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 ". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preanesthesia teleconsultationAccording to his allocated group, patient will have a teleconsultation at home/at work with an anaesthesiologist. | Procedure or surgery | Preanesthesia teleconsultation |
| preanesthesia traditional consultationAccording to his allocated group, patient will have a traditional consultation with an anaesthesiologist in the surgical center Emile Galle. | Procedure or surgery | Bis traditional consultation, Preanesthesia traditional consultation |
Primary outcome
Agreement concerning the risk of difficult intubation between preanesthesia consultation and visit.
Time frame: 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.
8 secondary outcomes
Agreement between preanesthesia consultation and visit concerning the risk of difficult mask ventilation
Time frame: 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
Time frame: 1 day before surgery or baseline (J0 = surgery day)
Agreement between preanesthesia consultation and visit concerning correct treatment management.
Time frame: 1 day before surgery or baseline (J0 = surgery day)
Agreement between preanesthesia consultation and visit concerning completeness of preoperative workup
Time frame: 1 day before surgery or baseline (J0 = surgery day)
Satisfaction of anesthesiologist
Time frame: 1 day before surgery or baseline (J0 = surgery day)
Satisfaction of patient
Time frame: 1 day before surgery or baseline (J0 = surgery day)
Preoperative anxiety of patient
Time frame: 1 day before surgery or baseline (J0 = surgery day)
Calculation of a ratio to evaluate the technical viability of generalising preanesthesia teleconsultation
Time frame: 1 day before surgery or baseline (J0 = surgery day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Derived from this study: PubMed 38700568Roche 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herve BOUAZIZ, PUPH principal investigator
Central HNF
Questions about this trial
What is this clinical trial studying?
A study testing preanesthesia teleconsultation and preanesthesia traditional consultation in people with Preanesthesia Consultation, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anaïs ROCHE (0627523294, anais_2025@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement concerning the risk of difficult intubation between preanesthesia consultation and visit. (time frame: 1 day before surgery or baseline (J0 = surgery day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.