Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.
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Duke University
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 27, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 31, 2018 | ||
| 预计主要完成日期 | July 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Time to normothermia.[ Time Frame: Core temperature readings for 24 hours post admission to intensive care unit. ] Core temperature normothermia defined as >=36.5 C. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients. | ||
| 正式标题 ICMJE | Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients. | ||
| 简要概况 | Hypothermia on admission to the intensive care unit (ICU) following cardiopulmonary bypass (CPB) is common. The investigators propose that rewarming hypothermic (≤ 35 C) patients admitted to the intensive care unit following procedures using CPB with heated humidified breathing circuits (HHBC) in addition to conventional forced air warming blankets will shorten time to normothermia. Secondarily it may shorten time to extubation, improve coagulopathy, and metabolic derangements seen with hypothermia. |
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| 详细说明 | Hypothermia on admission to the intensive care unit (ICU) following cardiopulmonary bypass (CPB) is common. Cooling and rewarming during CPB and deep hypothermic circulatory arrest (DHCA) takes considerable time and contributes to the post-procedural coagulopathy and physiologic perturbations. Core body parts (trunk and head) rewarm more quickly than peripheral parts (extremities). After disconnecting from CPB the body is allowed to self equilibrate. The normal vasoconstriction response is impaired by the administered anaesthesia. Hence, heat distribution takes place from the warm core to the colder periphery. This causes an afterdrop: a decrease in the temperature of the core organs. After-drop may contribute to post-operative complications such as shivering, coagulopathy, increased myocardial stress, increased wound infections, metabolic acidosis, delayed extubation and prolonged ICU length of stay (LOS). The use of the active warming via traditional methods (ie forced air warming blankets) and Heated Humidified breathing circuits (HHBC) via ANAPOD Heated Humidification System® (ANAPOD) may shorten time to normothermia. Secondarily it may shorten time to extubation, improve coagulopathy, and metabolic derangements seen with hypothermia. Sample and Study Design- The investigators will prospectively collect data for 14 enrolled non-patients who will receive active warming via both forced air warming blankets and Heated Humidified breathing circuits (HHBC). Retrospective data will be obtained retrospectively for 28 matched patients from two years prior to initiation of the trial, who received warming only via forced air warming blankets. Data Collection Plan- Data will be extracted and collected by the Duke Department of Anesthesiology IT analyst, who will review and extract information from the patient's chart via Epic/ Maestro Care, or manually if necessary. Data Evaluation- Descriptive statistics will be used to evaluate patient demographics and clinical characteristics. Descriptive statistics will be summarized as mean ± (SD) or median (interquartile range) for continuous variables and group frequencies (%) for dichotomous or categorical variables. As all patients are expected to achieve normothermia within the study period, the primary outcome of time to normothermia will be analyzed as a numeric outcome variable. Following validation of distributional assumptions the investigators will compare the time to normothermia between the two groups via t-test or Wilcoxon rank sum test as appropriate. It is expected that the patients will reach normothermia between 45 minutes and 6 hours after admission to the ICU. By using a 2:1 matching ratio and a moderate level of variability (SD=1.3 hours) a study of 14 prospectively enrolled patients and 28 retrospectively matched patients would attain 82% power to detect a 1.25 hour difference between time to normothermia in the prospective group (active warming via traditional methods (ie forced air warming blankets) and Heated Humidified breathing circuits (HHBC) via ANAPOD Heated Humidification System® (ANAPOD), and the retrospective group (active warming via traditional methods (ie forced air warming blankets only) at alpha level 0.05. Secondary numeric outcomes such as time to extubation, time to normal PH, and coagulopathy lab values will be analyzed by t-test or Wilcoxon rank sum test as appropriate. Differences in categorical outcomes between treatment groups will be analyzed via chi-square or fisher exact tests. As the patients will be matched on key confounders no further adjustment is expected to be necessary, so the moderate sample size should not limit the primary analysis. Potential subgroup analysis may be conducted in an exploratory analysis to determine if the treatment effect of ANAPOD warming is different by procedure type or patient/surgical characteristics. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: The intervention group has only one arm. All patients will use active warming via traditional methods (ie forced air warming blankets) and Heated Humidified breathing circuits (HHBC) via ANAPOD Heated Humidification System® (ANAPOD). Those patients will be matched with a retrospective historical cohort of patients that received active warming via traditional methods only (forced air warming blankets). 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
14 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | July 1, 2019 | ||
| 预计主要完成日期 | July 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Admission to intensive care unit following surgical procedure involving cardiopulmonary bypass. - Admission temperature ≤ 35.0 C. Exclusion Criteria: - Patients placed on extracorporeal membrane oxygenation intra-operatively, or during first 24 hours after ICU admission. - Any additional surgical procedures in the first 24 hours days after initial surgery e.g. Chest exploration for bleeding, Open Chest, Non-cardiac surgery such as colectomy for ischemic gut, etc. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Duke University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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