Teleconsultation vs Face-to-Face Evaluation for Perioperative Respiratory Events in Pediatric Adenotonsillectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 16
SponsorAndrea Saporito

About this trial

The goal of this clinical trial is to assess whether preoperative anesthesia teleconsultation is at least equivalent to in-person consultation in preventing perioperative respiratory adverse events (such temporary reduction in oxygen levels in the blood) in the operating room and in the first 24 hours after the surgery in pediatric adenotonsillectomy.

Researchers will compare the teleconsultation to in-person consultation to see if there is a difference in the frequency of respiratory adverse events in the operating room and during the first 24 hours after adenotonsillectomy.

Participants will:

\- undergo a traditional in-person anesthesiology consultation scheduled at the hospital or a online preoperative anesthesiology teleconsultation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients (up to 16 years of age) undergoing elective tonsillectomy or adenotonsillectomy

ASA (American Society of Anesthesiologists) physical status I to III,

Patients who have a parent or legal guardian able and willing to provide informed consent.

Disqualifiers

Parent or guardian unable or unwilling to provide informed consent,

Refusal to participate by parent/guardian,

Patients with contraindications to general anesthesia,

Known allergy to any drugs used in the anesthetic protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Face-to-Face Preanesthesia Consultation

    Other intervention

    Participants receive a standard preoperative anesthesia consultation in person at the hospital

  • Telemedicine Preanestehsia Consultation

    Other intervention

    Participants receive a preoperative anesthesia consultation remotely via video conferencing using a secure telemedicine platform.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Face-to-Face Preanesthesia ConsultationActive comparator 1 intervention
Group B: Telemedicine Preanesthesia ConsultationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of perioperative respiratory adverse events (PRAE)

including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing, recorded intraoperatively and up to 24 hours postoperatively.

Time frame
Intraoperatively
2

Incidence of PRAE (perioperative respiratory adverse events)

including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing

Time frame
up to 24 hours postoperatively

Secondary outcomes

1

Consultation duration

Time in minutes from the start to the end of the preoperative anesthesia consultation (either in-person or via telemedicine). The duration will be recorded by the anesthesiologist at the end of each consultation

Time frame
Day of consultation
2

preoperative assessment adequacy

Day-of-surgery cancellation rate

Time frame
Day of surgery
3

Preoperative anxiety in parents

Parental anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), a validated questionnaire with six self-reported items rated on a 5-point Likert scale (1 = not at all to 5 = extremely). Higher scores indicate greater anxiety and information need.

Time frame
Day of surgery
4

Preoperative anxiety in paediatric patients aged 8 years and older

For children aged 8 years and older, the Visual Analogue Scale for Anxiety (VAS-A) will be used, a self-reported 10-cm visual analogue with facial expressions ranging from "very distressed" to "very happy." Scores are recorded from 0 to 10, with higher scores indicating greater anxiety

Time frame
Day of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andrea Saporito

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution