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

NCT ID: NCT07175779

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-05-01

Brief Summary

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.

Detailed Description

Adenotonsillectomy is one of the most common surgical procedures in children, and perioperative respiratory adverse events (PRAEs) such as desaturation, laryngospasm, or bronchospasm represent a frequent source of morbidity. Careful preoperative anesthesiology evaluation is crucial to identify risk factors and to implement preventive strategies. Traditionally, this assessment is performed during an in-person consultation at the hospital. However, telemedicine has recently emerged as a potential alternative, offering advantages in terms of accessibility, cost-effectiveness, and reduced burden on families, especially when hospital access is challenging.

The primary aim of this randomized non-inferiority clinical trial is to determine whether a preoperative anesthesia teleconsultation is at least equivalent to a face-to-face consultation in preventing perioperative respiratory adverse events in pediatric patients undergoing adenotonsillectomy.

This trial will provide high-quality evidence regarding the safety and effectiveness of teleconsultation as a preoperative assessment strategy in pediatric surgery. If non-inferiority is demonstrated, the study could support the broader implementation of telemedicine in perioperative care pathways, potentially improving accessibility and reducing healthcare costs without compromising patient safety.

Conditions

Adenotonsillar Hypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Face-to-Face Preanesthesia Consultation

In-person preoperative anesthesia consultation

Group Type: ACTIVE_COMPARATOR

Face-to-Face Preanesthesia Consultation

Intervention Type: OTHER

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

Telemedicine Preanesthesia Consultation

Preoperative anesthesia teleconsultation via secure video platform

Group Type: ACTIVE_COMPARATOR

Telemedicine Preanestehsia Consultation

Intervention Type: OTHER

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

Interventions

Face-to-Face Preanesthesia Consultation

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

Intervention Type: OTHER

Telemedicine Preanestehsia Consultation

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Potential difficult airway,
• Poorly controlled chronic illness (e.g. asthma),
• Cardiac disease ,
• Genetic disorder,
• Haemoglobinopathy, anemia or clotting problem,
• Complex physical disability,
• Request from the patient or carer

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrea Saporito

OTHER

Sponsor Role: lead

Responsible Party

Andrea Saporito

Prof. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrea Saporito, MD, Prof.

Role: STUDY_DIRECTOR

Ente Ospedaliero Cantonale, Servizio di Anestesiologia

Locations

Ospedale Regionale Bellinzona e Valli

Bellinzona, Canton Ticino, Switzerland

Countries

Switzerland

Central Contacts

Alessandro Genini, MD

Role: CONTACT

alessandro.genini@eoc.ch

+41918118147

Roberto Dossi, MD

Role: CONTACT

roberto.dossi@eoc.ch

+41918119341

Other Identifiers

TELEPED-2025

Identifier Type: -

Identifier Source: org_study_id