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

Andrea Saporito

Status: Not yet enrolling

Conditions: Adenotonsillar Hypertrophy

Treatments: Other: Telemedicine Preanestehsia Consultation; Other: Face-to-Face Preanesthesia Consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT07175779

TELEPED-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

106 participants in 2 patient groups

Face-to-Face Preanesthesia Consultation

Active Comparator group

Description:

In-person preoperative anesthesia consultation

Treatment:

Other: Face-to-Face Preanesthesia Consultation

Telemedicine Preanesthesia Consultation

Active Comparator group

Description:

Preoperative anesthesia teleconsultation via secure video platform

Treatment:

Other: Telemedicine Preanestehsia Consultation