Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.

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Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 31, 2018

Estimated Primary Completion Date

July 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Time to extubation.[ Time Frame: 24 hours post admission to intensive care unit. ]
Time from admission to time of extubation.
Coagulopathy as measured by need for transfusion of blood product.[ Time Frame: 24 hours post admission to intensive care unit. ]
Assessed via number of transfusions of PRBC, FFP, Platelets, cryoprecipitate.
Metabolic Derangement as measured by time to normal PH (7.35-7.45)[ Time Frame: 24 hours post admission to intensive care unit. ]
Assessed via blood gas analysis.
Coagulopathy as measured by laboratory assessment of Prothrombin Time.[ Time Frame: 24 hours post admission to intensive care unit. ]
Laboratory assessment of Prothrombin Time with normal 9.5-13.1 seconds.
Coagulopathy as measured by laboratory assessment of INR.[ Time Frame: 24 hours post admission to intensive care unit ]
Laboratory assessment INR with normal 0.9-1.1.
Coagulopathy as measured by laboratory assessment of Act Partial Thromboplastin Time.[ Time Frame: 24 hours post admission to intensive care unit. ]
Laboratory assessment of Act Partial Thromboplastin Time with normal 26.8-37.1 seconds.
Coagulopathy as measured by laboratory assessment of fibrinogen.[ Time Frame: 24 hours post admission to intensive care unit. ]
Laboratory assessment of fibrinogen levels normal defined as 213-435 mg/dL.
Coagulopathy as measured by laboratory assessment of platelet count.[ Time Frame: 24 hours post admission to intensive care unit. ]
Laboratory assessment of platelet count with normal 150 - 450 x10ˆ9/L.

Descriptive Information

Brief Title ^ICMJE

Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.

Official Title ^ICMJE

Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.

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. 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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: 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).
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Device: Heated Humidified Breathing Circuit and Forced Air Blanket
Heated humidified breathing circuits (ANAPOD) will be set up and managed by respiratory therapist in standard fashion defined by the manufacturer. Temperate will be set at 41C. Forced air warming blankets will be set at 42C for duration of rewarming.

Study Arms

Experimental: HHBC and Forced Air Warming
Patients admitted to intensive care unit hypothermic (≤ 35 C) following surgical procedures involving cardiopulmonary bypass. Will be rewarmed with heated humidified breathing circuits (ANAPOD) and standard forced air warming blankets.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 1, 2019

Estimated Primary Completion Date

July 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Negmeldeen Mamoun, MD Duke Univeristy Hospital Anesthesia Department

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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