Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring by Non- Anesthesiologist During Percutaneous Endoscopic Gastrostomy (PEG), a Prospective, Randomized-controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- comparison of hypoxia in both arms
研究概览
简要总结
The present study is a randomized, prospective, single-blinded study. A total of 172 patients presenting for percoutaneous endoscopic gastrostomy (PEG) under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- standard monitoring (pulseoxymetry and non-invasive blood preassure monitoring) or group 2- standard monitoring and thoracic impedance measurement during Propofol-based sedation for PEG. Episodes of Hypoxia are documented and compared in both groups.
Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •> /= 18 years
- •given consent
- •planned PEG
排除标准
- •ASA >/= 4
- •no given consent
- •pregnant/laction
- •contraindication against PEG
- •contraindication against propofol-sedatation
研究组 & 干预措施
pulseoxymetry arm
pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring
干预措施: pulseoxymetry (Device)
pulseoxymetry arm
pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring
干预措施: non-invasive blood preassure monitoring (Device)
thoracic impedance monitoring arm
thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
干预措施: thoracic impedance monitoring (Device)
thoracic impedance monitoring arm
thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
干预措施: pulseoxymetry (Device)
thoracic impedance monitoring arm
thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
干预措施: non-invasive blood preassure monitoring (Device)
结局指标
主要结局
comparison of hypoxia in both arms
时间窗: Average duration period of PEG-placement: approx. 15 minutes.
Hypoxia is defined as oxygen saturation dropping below 90 % for more than 15 seconds. The primary end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient.
次要结局
- Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 %(Average duration period of PEG-placement: approx. 15 minutes.)
- Additional cost of thoracic impedance monitoring (TIM)(Time frame is the entire study period with a maximum of 3 years.)
- Risk stratification of baseline criteria for hypoxia(Time frame is the entire study period with a maximum of 3 years.)
- Comparison of satisfaction of patients in both arms(approx. 15 minutes)
- Comparison of severe hypoxia-episodes in both arms(Average duration period of PEG-placement: approx. 15 minutes. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient.)
- Comparison of the time difference of occuring apnoe before hypoxia(Average duration period of PEG-placement: approx. 15 minutes.)
- Specifity and sensetivity of thoracic impedance monitoring(Average duration period of PEG-placement: approx. 15 minutes.)
- Comparison of intervention procedures to prevent hypoxia(Average duration period of PEG-placement: approx. 15 minutes.)
- Comparison of satisfaction of doctors in both arms(approx. 15 minutes)
- Comparison of hypoxia-episodes in both arms(Average duration period of PEG-placement: approx. 15 minutes.)
- Comparison of satisfaction of nurses in both arms(approx. 15 minutes)
研究者
Georg Dultz
Clinical Professor
Johann Wolfgang Goethe University Hospital