Effect of Teleconsultation Compared to Face-to-Face Evaluation on Perioperative Respiratory Events in Pediatric Adenotonsillectomy: A Randomized Non Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Incidence of perioperative respiratory adverse events (PRAE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Face-to-Face Preanesthesia Consultation
In-person preoperative anesthesia consultation
干预措施: Face-to-Face Preanesthesia Consultation (Other)
Telemedicine Preanesthesia Consultation
Preoperative anesthesia teleconsultation via secure video platform
干预措施: Telemedicine Preanestehsia Consultation (Other)
结局指标
主要结局
Incidence of perioperative respiratory adverse events (PRAE)
时间窗: Intraoperatively
including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing, recorded intraoperatively and up to 24 hours postoperatively.
Incidence of PRAE (perioperative respiratory adverse events)
时间窗: up to 24 hours postoperatively
including desaturation, airway obstruction, laryngospasm, bronchospasm, and wheezing
次要结局
- 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)
- Environmental impact(Day of consultation (up to 24 hours post-consultation))
- Parental satisfaction(Day of consultation (up to 24 hours post-consultation))
- travel costs(Day of consultation (up to 24 hours post-consultation))
- Time off work for parents(Day of consultation (up to 24 hours post-consultation))
研究者
Andrea Saporito
Prof. Dr. med.
Ente Ospedaliero Cantonale, Bellinzona