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

March 19, 2018 updated by: Central Hospital, Nancy, France

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day before surgery or baseline (J0 = surgery day)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Agreement between preanesthesia consultation and visit concerning the risk of difficult mask ventilation
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 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
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 (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.
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 (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
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 (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
Time Frame: 1 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
1 day before surgery or baseline (J0 = surgery day)
Satisfaction of patient
Time Frame: 1 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
1 day before surgery or baseline (J0 = surgery day)
Preoperative anxiety of patient
Time Frame: 1 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
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Herve BOUAZIZ, PUPH, Central HNF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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