Идёт набор NCT07175779

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

Без фазы С лечением Adenotonsillar Hypertrophy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Face-to-Face Preanesthesia Consultation, Telemedicine Preanestehsia Consultation.
Кому может быть актуально: Состояния в реестре: Adenotonsillar Hypertrophy. Базовые параметры: до 16 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Teleconsultation Compared to Face-to-Face Evaluation on Perioperative Respiratory Events in Pediatric Adenotonsillectomy: A Randomized Non Inferiority Trial

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Face-to-Face Preanesthesia Consultation
Participants receive a standard preoperative anesthesia consultation in person at the hospital
Другое Telemedicine Preanestehsia Consultation
Participants receive a preoperative anesthesia consultation remotely via video conferencing using a secure telemedicine platform.

Первичные конечные точки

Incidence of perioperative respiratory adverse events (PRAE) [Срок оценки: Intraoperatively]
Incidence of PRAE (perioperative respiratory adverse events) [Срок оценки: up to 24 hours postoperatively]

Вторичные конечные точки (9)

Consultation duration [Срок оценки: Day of consultation]
preoperative assessment adequacy [Срок оценки: Day of surgery]
Preoperative anxiety in parents [Срок оценки: Day of surgery]
Preoperative anxiety in paediatric patients aged 8 years and older [Срок оценки: Day of surgery]
Preoperative anxiety in paediatric patients younger than 8 years [Срок оценки: Day of surgery]
Environmental impact [Срок оценки: Day of consultation (up to 24 hours post-consultation)]
Parental satisfaction [Срок оценки: Day of consultation (up to 24 hours post-consultation)]
travel costs [Срок оценки: Day of consultation (up to 24 hours post-consultation)]
Time off work for parents [Срок оценки: Day of consultation (up to 24 hours post-consultation)]

Критерии участия

Критерии включения

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.