Pilot Study : Evaluation of a Mandibular and Abdominal Motion Detection Sensors (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Optimal JAWAC signal threshold detecting obstructive apnea
研究概览
简要总结
Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
详细描述
In 2016 , monitoring of propofol sedation , currently recommended by the American Society of Anaesthesiology and European companies includes among others, a pulse oximeter (SpO2) and a continuous measurement of CO2 exhaled by an appropriate device (CapnoLine). This monitoring does not allow to anticipate the occurrence of obstructive apnea .
The anticipation of the occurrence of apnea or airway obstruction using this type of monitoring could allow the anesthesiologist to act earlier on the titration of propofol and maintaining the airway. This would avoid the side effects associated with hypoxemia and hypercapnia and therefore further improve patient safety .
This pilot study tests the JAWAC system to detect those apneas.
This is an interventional diagnostic study on the JAWAC monitoring system validation in a prospective cohort of patients undergoing sedation in order to provoke sleep apnea. Indeed , sedation technique is already used with propofol during snoring provocation tests in patients at risk for sleep apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult patient scheduled for a sleep apnea provocation test under sedation by propofol
- •Hospital Erasme during the period of the study.
排除标准
- •Patient Refusal
- •Patient Age: 18 years and under 80 years
- •Intervention earlier in the mandible or thorax
- •A history of facial burn
- •Allergy tape
研究组 & 干预措施
ALL INCLUDED PATIENTS
A single arm for this study. All the patients benefit of both systems. The participants are their own control.
Non invasive sensors are used to monitor and record data of those two systems in a synchron way ( JAWAC / Capnoline + Spo2).
干预措施: JAWAC system + Capnoline + Spo2 (Device)
结局指标
主要结局
Optimal JAWAC signal threshold detecting obstructive apnea
时间窗: at time of anesthesia
The apnea is defined clinically by the anesthesiologist with the help of the capnoLine/Spo2. The purpose is to define the optimal signal detection during a continuous record of the system JAWAC associated with the occurrence of obstructive apnea. The results will give a variation in centimeters for a certain amount of time. It is possible that the optimal signal detection will be a combination of different sensors. The sensibility, specificity versus precocity of the signal will be studied.
次要结局
- Time limit between the detection of each system and the episode of désaturation(at time of anesthesia)
研究者
Luc Barvais
Professor and head of the cardiothoracic and vascular anesthesia Clinics
Erasme University Hospital