Teleconsultation vs Face-to-Face Evaluation for Perioperative Respiratory Events in Pediatric Adenotonsillectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Face-to-Face Preanesthesia Consultation, Telemedicine Preanestehsia Consultation.
- Who it may be relevant to
- Registry conditions: Adenotonsillar Hypertrophy. Basic parameters: up to 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Teleconsultation Compared to Face-to-Face Evaluation on Perioperative Respiratory Events in Pediatric Adenotonsillectomy: A Randomized Non Inferiority Trial
Overview
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.
Interventions
- Other Face-to-Face Preanesthesia Consultation
Participants receive a standard preoperative anesthesia consultation in person at the hospital - Other Telemedicine Preanestehsia Consultation
Participants receive a preoperative anesthesia consultation remotely via video conferencing using a secure telemedicine platform.
Primary outcome measures
- Incidence of perioperative respiratory adverse events (PRAE) [Time frame: Intraoperatively]
- Incidence of PRAE (perioperative respiratory adverse events) [Time frame: up to 24 hours postoperatively]
Secondary outcome measures (9)
- Consultation duration [Time frame: Day of consultation]
- preoperative assessment adequacy [Time frame: Day of surgery]
- Preoperative anxiety in parents [Time frame: Day of surgery]
- Preoperative anxiety in paediatric patients aged 8 years and older [Time frame: Day of surgery]
- Preoperative anxiety in paediatric patients younger than 8 years [Time frame: Day of surgery]
- Environmental impact [Time frame: Day of consultation (up to 24 hours post-consultation)]
- Parental satisfaction [Time frame: Day of consultation (up to 24 hours post-consultation)]
- travel costs [Time frame: Day of consultation (up to 24 hours post-consultation)]
- Time off work for parents [Time frame: Day of consultation (up to 24 hours post-consultation)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Switzerland · 1 center
- Ospedale Regionale Bellinzona e Valli — Bellinzona
Identifiers
NCT: NCT07175779 · TELEPED-2025