Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of peripheral arterial desaturation
研究概览
简要总结
The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.
详细描述
The primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). Secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Symptoms of tracheal or laryngeal stenosis or airway narrowing
- •Endoscopic evidence of subglottic or tracheal stenosis
- •Able to provide informed consent
排除标准
- •Refractory stenosis not amenable to balloon dilatation
- •Contraindication to balloon dilatation
- •Lack of informed consent
研究组 & 干预措施
Dilatation
Patients undergoing tracheal dilatation with the study device
干预措施: improved tracheal balloon dilatation (Device)
结局指标
主要结局
Incidence of peripheral arterial desaturation
时间窗: During procedure (up to 60 minutes duration)
Incidence of desaturation below 90% as measured by peripheral pulse oximeter
Time to desaturation
时间窗: During procedure (up to 60 minutes duration)
Time to desaturation below 90% as measured by peripheral pulse oximeter
次要结局
- Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading(During procedure (up to 60 minutes duration))
- Incidence of major adverse events(During and within 24 hours of procedure)
研究者
Ross Hofmeyr
Consultant Anaesthesiologist and Clinical Research Fellow in Airway and Thoracic Anaesthesia
University of Cape Town