"Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of Participants With Epistaxis
研究概览
简要总结
Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal tube during nasotracheal intubation in children undergoing general anesthesia for dental surgery.
详细描述
The Parker flex-tip, midline-beveled nasotracheal tube theoretically slides past obstruction in the nasopharynx causing less mucosal damage than standard nasotracheal tubes.
The investigators aim to test whether mucosal injury during nasotracheal intubation in children undergoing general anesthesia for dental procedures can thus be minimized taking into consideration adenoid size, and differences in nasopharyngeal diameter.
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)
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between the ages of 3-11, ASA 1-3, presenting to Wolfson Children's Hospital (WCH) for dental procedures requiring general anesthesia with nasotracheal intubation.
排除标准
- •known bleeding disorders
- •recent or ongoing treatment with blood-thinning medicines
- •frequent epistaxis
- •active URI/congestion/rhinorrhea
- •craniofacial abnormalities prohibiting NTI
- •known difficult airway
- •prior nasal surgery/trauma
- •allergies to any of the medicines used in this study.
研究组 & 干预措施
standard nasotracheal tube
Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes
干预措施: Standard nasotracheal tube (Device)
Parker flex-tip nasotracheal tube
Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes
干预措施: Parker flex-tip nasotracheal tube (Device)
结局指标
主要结局
Number of Participants With Epistaxis
时间窗: within approximately 4hrs of surgery (day of surgery)
Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx.
次要结局
- Number of Participants With Postoperative Croup(end of surgery until time of discharge, approximately 4hrs)
- Number of Participants With Nasotracheal Tube Impingement(perioperative, immediate during intervention - expected 2hrs (day of surgery))
- Number of Participants With Postoperative Epistaxis(Participants will be followed for the duration of the hospital stay, an expected average of 6 hours)
- Time to Discharge in Minutes(emergence from anesthesia to meeting discharge criteria, approximately 4hrs)