NCT07175779

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Dec 2025May 2027

First Submitted

Initial submission to the registry

August 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

August 4, 2025

Last Update Submit

March 13, 2026

Conditions

Adenotonsillar Hypertrophy

Keywords

Anesthesia ConsultationFace-to-Face VisitRemote consultationPatient anxietyPatient SatisfactionLost Work TimeDistance TraveledVirtual CareDigital HealthTelemedicinePerioperative CarePerioperative respiratory adverse events (PRAE)AdenotonsillectomyTonsillectomy

Outcome Measures

Primary Outcomes (2)

  • Incidence of perioperative respiratory adverse events (PRAE)

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

    Intraoperatively

  • Incidence of PRAE (perioperative respiratory adverse events)

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

    up to 24 hours postoperatively

Secondary Outcomes (9)

  • Consultation duration

    Day of consultation

  • preoperative assessment adequacy

    Day of surgery

  • Preoperative anxiety in parents

    Day of surgery

  • Preoperative anxiety in paediatric patients aged 8 years and older

    Day of surgery

  • Preoperative anxiety in paediatric patients younger than 8 years

    Day of surgery

  • +4 more secondary outcomes

Study Arms (2)

Face-to-Face Preanesthesia Consultation

ACTIVE COMPARATOR

In-person preoperative anesthesia consultation

Other: Face-to-Face Preanesthesia Consultation

Telemedicine Preanesthesia Consultation

ACTIVE COMPARATOR

Preoperative anesthesia teleconsultation via secure video platform

Other: Telemedicine Preanestehsia Consultation

Interventions

Face-to-Face Preanesthesia ConsultationOTHER

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

Face-to-Face Preanesthesia Consultation
Telemedicine Preanestehsia ConsultationOTHER

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

Telemedicine Preanesthesia Consultation

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale Bellinzona e Valli

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Andrea Saporito, MD, Prof.

    Ente Ospedaliero Cantonale, Servizio di Anestesiologia

    STUDY DIRECTOR

Central Study Contacts

Alessandro Genini, MD

CONTACT

+41918118147alessandro.genini@eoc.ch

Roberto Dossi, MD

CONTACT

+41918119341roberto.dossi@eoc.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 4, 2025

First Posted

September 16, 2025

Study Start

December 11, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

CH(1)