Cuffed Versus Uncuffed Tracheal Tubes in Neonates Undergoing Elective Surgery: a Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The incidence of ETT exchange to find the appropriate ETT
研究概览
简要总结
This thesis aims to assess the safety and efficacy of usage of cuffed ETT in neonate undergoing elective surgeries.
详细描述
Neonates will be recruited into the trial during pre-operative assessment. Recruited neonates will be randomly assigned to one of two groups in a 1:1 ratio; (group C) to receive a cuffed ETT and (group U) to receive an uncuffed ETT for airway management. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes.
All neonates will be anesthetized in accordance with the local policy of pediatric anesthesia unit in Abu El-Reesh pediatric hospital-Cairo university after ethics committee approval.
After preoperative examination and upon arrival to the operating room heart rate, noninvasive blood pressure NBP and oxygen saturation SPO2 will be monitored using standard monitor (drȁger infinity vista XL) before inhalational induction of anesthesia using titration of sevoflurane in oxygen air mixture 60% (starting from 3% up to 8%) until the neonate is put to sleep. Baseline lung ultrasound will then be done. After securing an intravenous line anesthesia will be completed with 1-2µg/kg of fentanyl and atracurium 0.5 mg/kg.
Induction of anesthesia will be performed by the attending senior anesthesia resident who has finished at least 2 years of residency (who is independent of the study team).
(Microcuff®, Halyard Health Inc., Atlanta, GA, USA), will be chosen for cuffed TTs, and (Mallinckrodt® Contour Murphy Eye) for non-cuffed tubes.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Induction of anesthesia will be performed by the attending senior anesthesia resident who has finished at least 2 years of residency (who is independent of the study team).
All intraoperative measurements will be collected by an anesthetist who was not involved in the induction of anesthesia.
All postoperative measurements will be collected by PACU nurse who is independent of the study team
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Neonates (infant in the first 28 days after birth)
- •Full term (more than 37 gestational weeks)
- •More than 3 kg bodyweight
- •Scheduled for elective surgeries under general anesthesia requiring endotracheal intubation.
排除标准
- •• Parents or legally authorized personnel refusal.
- •Anatomical abnormalities of upper air way.
- •Emergency surgery.
- •Low birth weight less than 3 kg
- •Surgery longer than 2 hours
- •Premature neonates
- •Upper airway surgery
- •Requirement for postoperative ventilation
结局指标
主要结局
The incidence of ETT exchange to find the appropriate ETT
时间窗: 2 hours
the incidence of ETT exchange to find the appropriate ETT defined as:(the absence of resistance to insertion of the tube and the presence of audible leak with inflation pressures of 20 cmH2O).
次要结局
- Desaturation incidence(30 minutes postoperative)
- Leakage around the ETT(2 hours)
- Number of attempts to insert and correctly size the tracheal tube.(10 minutes)
- Duration of intubation(10 minutes)
- Hoarseness of voice.(30 minutes postoperative)
- Croup incidence(30 minutes postoperative)
研究者
Khaled Abdelfattah Abdallah Sarhan
Lecturer of Anesthesia
Kasr El Aini Hospital