Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Time to Normothermia
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Time to Normothermia
Time Frame: up to 24 hours post admission to intensive care unit
Core temperature normothermia defined as \>=36.5 C.
Secondary Outcomes
- Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Act Partial Thromboplastin Time(24 hours post admission to intensive care unit)
- Time to Extubation(up to 24 hours post admission to intensive care unit)
- Coagulopathy as Measured by Need for Transfusion of Blood Product(24 hours post admission to intensive care unit)
- Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Prothrombin Time(24 hours post admission to intensive care unit)
- Metabolic Derangement as Measured by Time to Normal pH(up to 24 hours post admission to intensive care unit)
- Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of INR(24 hours post admission to intensive care unit)
- Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Fibrinogen.(24 hours post admission to intensive care unit)
- Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Platelet Count(24 hours post admission to intensive care unit)