Adenotonsillar HypertrophyTelepedNCT07175779
Teleconsultation vs Face-to-Face Evaluation for Perioperative Respiratory Events in Pediatric Adenotonsillectomy
A study testing Face-to-Face Preanesthesia Consultation and Telemedicine Preanestehsia Consultation in people with Adenotonsillar Hypertrophy, run by Andrea Saporito at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Adenotonsillar Hypertrophy
- What is being tested?
- Face-to-Face Preanesthesia Consultation and Telemedicine Preanestehsia Consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Dec 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 11Show fewer
- Cardiac disease ,
- Genetic disorder,
- Haemoglobinopathy, anemia or clotting problem,
- Complex physical disability,
- Request from the patient or carer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Regionale Bellinzona e Valli
Bellinzona, Canton Ticino, 6500
About this study
Official title: Effect of Teleconsultation Compared to Face-to-Face Evaluation on Perioperative Respiratory Events in Pediatric Adenotonsillectomy: A Randomized Non Inferiority 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.
Read more
Participants will:
- undergo a traditional in-person anesthesiology consultation scheduled at the hospital or a online preoperative anesthesiology teleconsultation.
Read the 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
- Being tested
- Face-to-Face Preanesthesia Consultation, Telemedicine Preanestehsia Consultation
- Keywords
- Anesthesia Consultation, Face-to-Face Visit, Remote consultation, Patient anxiety, Patient Satisfaction, Lost Work Time, Distance Traveled, Virtual Care, Digital Health, Telemedicine, Perioperative Care, Perioperative respiratory adverse events (PRAE), Adenotonsillectomy, Tonsillectomy
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-Face Preanesthesia ConsultationOther
Participants receive a standard preoperative anesthesia consultation in person at the hospital
Telemedicine Preanestehsia ConsultationOther
Participants receive a preoperative anesthesia consultation remotely via video conferencing using a secure telemedicine platform.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Preanesthesia Consultation | Active comparator | In-person preoperative anesthesia consultation Receives: Other: Face-to-Face Preanesthesia Consultation |
| Telemedicine Preanesthesia Consultation | Active comparator | Preoperative anesthesia teleconsultation via secure video platform Receives: Other: Telemedicine Preanestehsia Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative respiratory adverse events (PRAE)
including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing, recorded intraoperatively and up to 24 hours postoperatively.
Measured: Intraoperatively
Incidence of PRAE (perioperative respiratory adverse events)
including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing
Measured: up to 24 hours postoperatively
Secondary outcomes (9)
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
Measured: Day of consultation
preoperative assessment adequacy
Day-of-surgery cancellation rate
Measured: Day of surgery
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.
Measured: Day of surgery
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
Measured: Day of surgery
Preoperative anxiety in paediatric patients younger than 8 years
For children younger than 8 years, the modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF) will be used, which evaluates five behavioral domains (activity, vocalization, emotional expressivity, state of arousal, and interaction with parents) on a 1-5 scale. Higher scores indicate greater observable anxiety
Measured: Day of surgery
Environmental impact
estimated in terms of CO₂ emissions potentially avoided based on the number of kilometers not traveled by car
Measured: Day of consultation (up to 24 hours post-consultation)
Parental satisfaction
assessed using a Numeric Rating Scale (NRS) ranging from 1 (not satisfied at all) to 10 (extremely satisfied)
Measured: Day of consultation (up to 24 hours post-consultation)
travel costs
Direct travel-related expenses (e.g., fuel, public transport, parking) incurred by the family to attend the preoperative anesthesia consultation. Costs will be self-reported by parents using a structured questionnaire, expressed in local currency
Measured: Day of consultation (up to 24 hours post-consultation)
Time off work for parents
Number of working hours lost by parents or guardians in order to attend the preoperative anesthesia consultation. Data will be self-reported in a post-consultation questionnaire, expressed in hours
Measured: Day of consultation (up to 24 hours post-consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start11 Dec 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenotonsillar HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Saporito
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Saporito, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Andrea Saporito, MD, Prof., Study director, Ente Ospedaliero Cantonale, Servizio di Anestesiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175779
- Sponsor's protocol ID
- TELEPED-2025
- Acronym
- Teleped
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Teleconsultation Compared to Face-to-Face Evaluation on Perioperative Respiratory Events in Pediatric Adenotonsillectomy: A Randomized Non Inferiority Trial
- ClinicalTrials.gov ID
- NCT07175779
- Acronym / sponsor ID
- Teleped / TELEPED-2025
- Conditions
- Adenotonsillar Hypertrophy
- Keywords
- Anesthesia Consultation, Face-to-Face Visit, Remote consultation, Patient anxiety, Patient Satisfaction, Lost Work Time, Distance Traveled, Virtual Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Andrea SaporitoUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Preanesthesia Consultation | Active comparator | Other: Face-to-Face Preanesthesia ConsultationIn-person preoperative anesthesia consultation |
| Telemedicine Preanesthesia Consultation | Active comparator | Other: Telemedicine Preanestehsia ConsultationPreoperative anesthesia teleconsultation via secure video platform |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-Face Preanesthesia ConsultationParticipants receive a standard preoperative anesthesia consultation in person at the hospital | Other | Face-to-Face Preanesthesia Consultation |
| Telemedicine Preanestehsia ConsultationParticipants receive a preoperative anesthesia consultation remotely via video conferencing using a secure telemedicine platform. | Other | Telemedicine Preanesthesia Consultation |
Primary outcome
Incidence of perioperative respiratory adverse events (PRAE)
Time frame: Intraoperatively
including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing, recorded intraoperatively and up to 24 hours postoperatively.
Incidence of PRAE (perioperative respiratory adverse events)
Time frame: up to 24 hours postoperatively
including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Saporito, MD, Prof. study director
Ente Ospedaliero Cantonale, Servizio di Anestesiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face Preanesthesia Consultation and Telemedicine Preanestehsia Consultation in people with Adenotonsillar Hypertrophy, run by Andrea Saporito at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Genini, MD (+41918118147, alessandro.genini@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perioperative respiratory adverse events (PRAE) (time frame: Intraoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.