Temperature Control With an Esophageal Cooling Device: A Feasibility Study in Post Cardiac Arrest Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percent of time maintained within 0.5°C range of the 35°C input target, in the hypothermia maintenance phase.
研究概览
简要总结
This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest patients. In addition, observed adverse events during ECD use, ease-of-use, nurse satisfaction and patient outcomes will be examined.
详细描述
Temperature control in comatose survivors of cardiac arrest, is a critical aspect of these patients' care. In this context, mild temperature reduction for 24 hours post cardiac arrest has been shown to improve neurological outcomes.
Hypothermia is commonly induced using a combination of internal and external cooling modalities. Internal cooling modalities include intravenous administration of cold crystalloids and intravascular cooling catheters. External or body surface cooling can be achieved using cooling blankets, adhesive pads, and ice packs. Each of these methods however, has its limitations.
Administration of intravenous refrigerated crystalloid (4°C) boluses is a simple, effective and widely available method of hypothermia induction. Lack of precise temperature control and the potential for pulmonary edema however, make this modality unsuitable for the maintenance phase of hypothermia. Surface cooling methods, such as cooling blankets and ice packs, often cause shivering, skin breakdown, and in obese patients may be ineffective. Intravascular cooling catheters require the time of a physician for insertion and bear the potential risks of line infection and deep venous thrombosis. Searching for a temperature control device that overcomes the limitations, inefficiencies and inconveniences of existing modalities is therefore strongly desired.
The ideal temperature control modality should be effective, predictable and easy to use. An esophageal cooling device has recently become available which in theory may, may possess some of these attributes. To date, there have been no published studies examining this device's efficacy. In addition, no study has documented any adverse events during it's use, or evaluated it's ease-of-use at the bedside.
This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in comatose survivors of cardiac arrest (the E-Chill trial). In addition, observed adverse events during ECD use, ease-of-use, nurse satisfaction and patient outcomes will be examined.
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
- •Patients admitted to the intensive care unit after resuscitation from an out-of-hospital cardiac arrest.
- •Sustained return of spontaneous circulation (no chest compressions required for >20 minutes)
- •Not obeying commands to verbal instruction.
- •On mechanical ventilation via endotracheal tube or tracheotomy.
排除标准
- •Known esophageal deformity (known esophageal varices, history of esophagectomy, previous swallowing disorders, achalasia, etc.) or evidence of esophageal trauma.
- •Known ingestion of acidic or caustic poisons within the prior 24 hours.
- •Patients with less than 40 kg of body mass.
- •Patients known to be pregnant.
- •Uncontrolled coagulopathy.
- •Documented intracranial hemorrhage.
- •Patients presenting to the intensive care unit with a temperature < 35°C.
- •Time from collapse to return of spontaneous circulation > 45 minutes or unknown.
- •Time from collapse to starting chest compressions > 10 minutes or unknown.
- •Time from collapse to assessment for enrollment > 12 hours.
- •Patients thought to have a very low chance of surviving the next 48 hours as assessed by the research team.
研究组 & 干预措施
Esophageal temperature control
The Esophageal Cooling Device (ECD) will be inserted and utilized for temperature control for up to 36 hours in this arm. The ECD will be used for all three phases of therapeutic hypothermia; induction, maintenance, and rewarming. Conventional cooling or warming techniques (e.g. cold saline, ice packs, cooling or warming blankets) will still be made available to the treating ICU team to be used at their discretion.
干预措施: Esophageal temperature control (Device)
结局指标
主要结局
Percent of time maintained within 0.5°C range of the 35°C input target, in the hypothermia maintenance phase.
时间窗: Within 36 hours of ECD insertion.
Once patient temperature is within 0.5°C from the 35°C target, the maintenance phase will commence. The amount of time patient temperature is maintained within ± 0.5 from 35°C, as a percentage of the total hypothermia maintenance time (24 hours) will be examined. Confidence intervals for the results will be reported.
次要结局
- Cooling rate in hypothermia induction phase.(Within 10 hours of ECD insertion.)
- Adverse events during and after ECD use.(Within 4 weeks of enrollment or until hospital discharge whichever comes first.)
- Percent of time patient temperature is within 0.5°C range of the input target, 30 minutes after each target elevation in the rewarming phase.(Within 36 hours of ECD insertion.)
- Ease-of-use.(Within 40 hours of enrollment.)
- Patient neurological outcome as defined by the Cerebral Performance Category.(Within 4 weeks of enrollement or until hospital discharge whichever comes earlier.)
- ECD insertion time.(Within 4 hours of enrollment.)
- Need for other cooling or warming modalities during ECD use.(Within 36 hours of ECD insertion.)