Hypothermia Clinical Trial
Official title:
Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.
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.
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.
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