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临床试验/NCT06742476
NCT06742476已完成不适用

Effectiveness Of Apneic Oxygenation During Induction Of General Anesthesia In Children Undergoing Adenotonsillectomy (As Partially Obstructed Airway)

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Lowest oxygen saturation during tracheal intubation.

研究概览

简要总结

During general anesthesia, the administration of anesthetics and muscle relaxants induces apnea, wherein spontaneous breathing ceases . Pediatric patients, characterized by their higher oxygen consumption rate and smaller functional residual capacity, are particularly susceptible to hypoxemia during apneic episodes . This vulnerability to hypoxemia underscores the critical need for effective oxygenation strategies during anesthesia. Apneic oxygenation, the provision of oxygen without concurrent tidal volume delivery, emerges as a vital technique in pediatric anesthesia, playing a pivotal role in both routine and challenging airway management scenarios .

In modern practice, apneic oxygenation during airway management denotes the uninterrupted supply of oxygen, extending the window for maintaining safe oxygen saturation levels during the apneic phase . This technique holds particular significance in pediatric patients undergoing adenotonsillectomy, where the delicate balance of oxygenation is paramount .

Adenotonsillectomy, a common surgical procedure in pediatric patients, poses unique challenges in airway management . The procedure involves the removal of the adenoids and tonsils, often necessitating general anesthesia and temporary airway obstruction . Furthermore, the potential for blood and secretions in the oropharynx increases the risk of airway compromise during the perioperative period. In this context, ensuring adequate oxygenation is essential to mitigate the risk of hypoxemia and its associated complications In this randomized clinical trial, the investigators aim to evaluate the efficacy and safety of apneic oxygenation using nasal cannula in pediatric patients undergoing adenotonsillectomy under general anesthesia. By assessing our primary outcome and secondary outcomes, the investigators seek to contribute valuable insights into optimizing anesthesia management protocols for this vulnerable patient population.

详细描述

Following permission from the local institutional review board and institutional ethics committee, this study will be carried out at the FAYOUM University hospital. The research will employ a single -blinded, randomized, and controlled approach.

Prior to recruitment and randomization, detailed consent will be obtained from the parents or legal guardians of eligible patients.

Patients were randomly allocated 1: 1 to the two study groups:

Group (A):

Patients in the group A will undergo tracheal intubation without apneic oxygenation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients (3 - 10 Years).
  • •Patients who were scheduled for adenotonsillectomy.
  • •ASA I and II

排除标准

  • •When nasal intubation is needed.
  • •Patients reported with nasal obstruction.
  • •Patients with any respiratory disease like asthma or recent upper respiratory tract infection.
  • •Patients with obstructive sleep apnea
  • •Patients with congenital heart disease
  • •Patients suspected difficult intubation or syndromatic patients eg : down syndrome , Goldenhar Syndrome , Pierre Robin syndrome … etc

研究组 & 干预措施

control group

No Intervention

Patients in the group A will undergo tracheal intubation without apneic oxygenation

apniec oxygenation group

Experimental

Patients in the group B will undergo tracheal intubation in addition to apneic oxygenation at a flow 0.2 mg/kg using nasal cannula

干预措施: nasal cannula (Device)

结局指标

主要结局

Lowest oxygen saturation during tracheal intubation.

时间窗: at the end of intubation procedure

Following intubation, SpO2 levels will be recorded

次要结局

  • Number of patients that their spo2 dropped to 95%.(at the end of intubation procedure)
  • Number of patients that their spo2 dropped to 92%.(at the end of intubation procedure)
  • Number of patients that their spo2 dropped to below 92%.(at the end of intubation procedure)
  • Spo2 base line Spo2 after bag and mask ventillation and Spo2 immediately after intubation.(at the end of intubation procedure)
  • Number of intubation attempts.(at the end of intubation procedure)
  • Time of intubation.(at the end of intubation procedure)
  • Number of patients developed bradycardia.(at the end of the study ( 6 months ))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Safaa Gaber Ragab

Associate professor of anaesthiology

Fayoum University Hospital

研究点 (1)

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