Pre-anesthetic Teleconsultations During Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
Quality of teleconsultation in comparison to face-to-face consultation for pre anesthetic evaluation in pregnant persons before delivery will be evaluated. Quality is evaluated with a composite criterion comprising 7 elements required for security of anesthesia. Discordance between this composite criterion during the pre anesthesia visit the day of delivery and pre anesthesia consultation several weeks before delivery will be assessed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant patients scheduled to give birth at the Bordeaux University Hospital, ASA score 1 or 2, for their primary pregnancy, who have booked an anesthesia appointment on one of the half-days when teleconsultation is available in the department
Have access to the internet and functional computer equipment (smartphone, computer)
Have a valid email address and telephone number
Disqualifiers
Minor patient (under 18 years old at the time of inclusion)
Individuals not affiliated with or beneficiaries of a social security scheme
Patients who do not speak French
Persons under legal guardianship
Trial design
Design model
Parallel
Treatments tested in this trial
Teleconsultation
Procedure/Surgerypre-anesthetic consultation conducted conducted at the Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital.
on-site consultation
Procedure/SurgeryIn-person consultation conducted at the Bordeaux University Hospital according to the usual procedure.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: TeleconsultationExperimental treatment 1 intervention
Group B: In-person consultationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite quality criterion
The primary endpoint will be the discordance between the pre-anesthetic consultation and the pre-anesthetic visit based on a composite quality criterion comprising 7 elements: * Assessment of difficult intubation, defined as a mouth opening \<35 mm * Description of pre-anesthesia medication reconciliation (except therapeutic adjustments in anticoagulants and antidiabetic treatments) * Anesthetic strategy associated with a documented chronic condition if a specific strategy is needed * Adherence to pre-transfusion assessment protocols * Documentation of hematologic assessment in the 6th month, or prescription of assessment in case of absence * Therapeutic approach in case of anemia described * Criteria of difficulty in performing epidural anesthesia This primary criterion will be assessed at the conclusion of the pre-anesthetic visit.
Time frame
during pre-anesthetic visit, up to 2 months after inclusion (pre-anesthetic consultation)Secondary outcomes
1
Patient satisfaction
This questionnaire will include an overall assessment based on the question: "To what extent are you satisfied with your appointment with the anesthesiologist?", rated on a 5-point Likert scale (Very satisfied / Somewhat satisfied / Neither satisfied nor dissatisfied / Somewhat dissatisfied / Very dissatisfied) The remainder of the questionnaire will be developed for this study based on the validated CARE questionnaire. The CARE questionnaire is a tool developed by Stewart W. Mercer, initially for general practice, and validated in 2004. It focuses on the empathy patients perceive during consultations. It consists of 10 questions, rated on Likert scales.
Time frame
2 weeks after inclusion (pre-anesthetic consultation)2
Anesthesiologist satisfaction
The experience of telemedicine consultations by anesthesiologists will be evaluated at the end of each half-day of consultations. Anesthesiologists and intensivists will be asked to complete a questionnaire consisting of 6 questions: Each response will be rated on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree"
Time frame
at inclusion (pre anesthetic consultation)3
missed appointment
A missed appointment is defined as the failure to conduct a pre-anesthetic consultations on the scheduled day due to the patient's absence or tardiness at the time of the appointment. Data on missed appointments will be collected for each patient included in the study. The rate of missed or rescheduled appointments will be calculated for each group.
Time frame
at inclusion (pre anesthetic consultation)4
Epidural anesthesia difficult to perform
The number of epidural anesthesias that are difficult to administer will be recorded. The criteria used to define a difficult administration are: more than three attempts at puncture or the involvement of a second practitioner.
Time frame
up to 2 month after inclusionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: