NCT02546830已完成不适用
Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Percentage of time spent in the target zone of oxygen saturation
研究概览
简要总结
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.
The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Preoperative anesthetic visit for major thoracic or abdominal surgery ( ARISCAT risk score ≥ 26) with general anesthesia
- •Patient consent
- •Randomization Criteria:
- •Admission in post-anesthesia care unit after major thoracic or abdominal surgery
- •Randomization and device establishment within a time less than one hour after the endotracheal intubation
- •Availability of the prototype FreeO2
- •Absence of criteria of gravity justifying immediately a different technique of ventilatory support:
- •Disturbance of consciousness with a Glasgow Coma Score ≤ 12
- •Serious ventricular rhythm disorders
- •Hemodynamic instability (SBP <80mmHg or recourse to vasopressors)
- •Cardiac or respiratory arrest
- •pH < 7.35 and PaCO2 > 55 mm Hg
- •Necessity of an oxygen flow less than 15 L / min to maintain a SpO2 higher than 92%.
- •Absence of necessity of a urgent surgery
- •Oxygen saturation measured by Spo2 sensor
排除标准
- •BMI ≥ 35 kg/m2
- •Obstructive sleep Apnea (with or without Mechanical therapy)
- •Emergency Surgery for life-threatening
- •Age <18 years
- •Pregnant women, lactating
- •perturbed or non-cooperative patient
研究组 & 干预措施
FreeO2 v2.2 active
Experimental
Automatic Oxygen Administration
干预措施: FreeO2 v2.2 active (Device)
FreeO2 v2.2 with manual oxygenation
Active Comparator
Manual Oxygen Administration
干预措施: FreeO2 v2.2 with manual oxygenation (Device)
结局指标
主要结局
Percentage of time spent in the target zone of oxygen saturation
时间窗: 3 days
The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD
次要结局
- Maintaining EtCO2 in a selected area(3 days)
- Number of complications related to the administration of oxygen(28 days max)
- Frequency of use of ventilation (invasive or noninvasive )(28 days max)
- Time spent in a area of severe desaturation (SpO2 <85%)(3 days)
- Time spent in a hyperoxia area (SpO2> 98%).(3 days)
- Oxygen consumption measured at the end of administration(3 days)
- Duration of hospitalization(28 days max)
- nursing workload(3 days)
- Duration of oxygen administration during hospitalization(3 days)
研究者
研究点 (5)
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