FiO2 Closed Loop Control Using the ZOLL 731 Series Ventilator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]
研究概览
简要总结
A randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (FiO2) within a target range, with a computer-controlled, closed-loop FiO2 delivery using a continuous ventilator.
详细描述
The trial will use a proportional-integral-derivative (PID) type controller for automatic adjustment of FiO2 to maintain the SpO2 within a target range, based on continuous use of pulse oximetry. Intubated subjects will be randomized to either manual control of FiO2 or closed-loop control of FiO2, during a 12-hour period. The PCLC is designed to respond to acute hypoxemia (SpO2 <88%) within seconds while preventing hypoxemia and minimizing exposure to excessive inspired oxygen levels.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject's legally authorized representative will provide signed and dated informed consent.
- •Age 18 - 65, inclusive.
- •Admission to a surgical or neurosurgical intensive care unit following traumatic injury or acute surgical illness
- •Requirement for endotracheal intubation
- •Requirement for mechanical ventilation
- •Patient is currently receiving inspired oxygen concentration (FiO2) >=40%
排除标准
- •Age under 18 or over 65
- •Isolated or severe head injury (Glasgow Coma Scale = 6 or less) with expected survival less than 24 hours
- •Brain death
- •Anticipated survival less than 48 hours
- •Pregnant female
- •Patient in whom a pulse oximeter cannot detect a reliable signal due to hypotension, hypothermia, or other injury
- •Known carbon monoxide poisoning
- •Uncontrolled diabetic
- •Patient who is unable to maintain SpO2 level of 88% at an FiO2 of 100% due to their medical condition. (NOTE: Being in the trial would impose no additional risk to a patient who presents with this condition however, data from a patient presenting with this pathophysiology would not provide insight into the performance of the controller as it would simply maintain that patient on an FiO2 of 100%.)
- •Patient with chronic hypercarbia.
- •Patient where a physician believes that FiO2 PCLC could be detrimental to the management of the patient.
- •SpO2 to SaO2 difference >4%
- •Patient with core temperature <35 C
结局指标
主要结局
Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours]
时间窗: 12 hours
Relative duration is (time within SpO2 target of 92-96%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the 92 - 96% range divided by 12 hours with arcsin square root transformation
Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device
时间窗: 24 hours after intervention
Number of participants with SpO2 less than 88% at anytime while on study device
次要结局
- Relative Duration of Time With SpO2 92 to 96% When FiO2 is Greater Than 21% and SpO2 is Greater Than or Equal to 92% When Fi02 "Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours](12 hours)