Trial Outcomes & Findings for Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients. (NCT NCT03697122)

NCT ID: NCT03697122

Last Updated: 2020-07-15

Results Overview

Core temperature normothermia defined as \>=36.5 C.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: up to 24 hours post admission to intensive care unit
• Results posted on: 2020-07-15

Participant Flow

Participant milestones

Measure	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. 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.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	HHBC and Forced Air Warming n=14 Participants 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. 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.
Age, Continuous	65.4 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants
Temperature at ICU admission	34 Degrees Celsius n=5 Participants

PRIMARY outcome

Timeframe: up to 24 hours post admission to intensive care unit

Core temperature normothermia defined as >=36.5 C.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Time to Normothermia

4.4 hours Interval 3.5 to 5.5

SECONDARY outcome

Timeframe: up to 24 hours post admission to intensive care unit

Time from admission to time of extubation. Followup was truncated at 24 hours and if patient had not been extubated at that time they were assigned a value of 24 hours.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Time to Extubation

5.4 hours Interval 4.9 to 8.0

SECONDARY outcome

Timeframe: 24 hours post admission to intensive care unit

Assessed via number of transfusions of red blood cells, fresh frozen plasma, platelets, cryoprecipitate.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Coagulopathy as Measured by Need for Transfusion of Blood Product

0 Units transfused Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: up to 24 hours post admission to intensive care unit

Assessed via blood gas analysis. Normal pH defined as 7.35-7.45.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Metabolic Derangement as Measured by Time to Normal pH

0.4 hours Interval 0.2 to 4.8

SECONDARY outcome

Timeframe: 24 hours post admission to intensive care unit

Laboratory assessment of Prothrombin Time with normal defined as 9.5-13.1 seconds.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Prothrombin Time

12 Participants

SECONDARY outcome

Timeframe: 24 hours post admission to intensive care unit

Laboratory assessment of international normalised ratio (INR) with normal defined as 0.9-1.1.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of INR

12 Participants

SECONDARY outcome

Timeframe: 24 hours post admission to intensive care unit

Laboratory assessment of Act Partial Thromboplastin Time with normal defined as 26.8-37.1 seconds.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Act Partial Thromboplastin Time

10 Participants

SECONDARY outcome

Timeframe: 24 hours post admission to intensive care unit

Laboratory assessment of fibrinogen levels with normal defined as 213-435 mg/dL.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Fibrinogen.

5 Participants

SECONDARY outcome

Timeframe: 24 hours post admission to intensive care unit

Laboratory assessment of platelet count with normal defined as 150 - 450 x10ˆ9/L.

Outcome measures

Measure

HHBC and Forced Air Warming n=14 Participants 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. 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.

Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Platelet Count

7 Participants

Adverse Events

HHBC and Forced Air Warming

Serious events: 2 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	HHBC and Forced Air Warming n=14 participants at risk 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. 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.
Cardiac disorders Complete Heart Block	7.1% 1/14 • Number of events 1 • From ICU admission to hospital discharge (ranged between 5 and 9 days)
Vascular disorders Hemorrhagic Stroke	7.1% 1/14 • Number of events 1 • From ICU admission to hospital discharge (ranged between 5 and 9 days)
Renal and urinary disorders Acute Kidney Injury	7.1% 1/14 • Number of events 1 • From ICU admission to hospital discharge (ranged between 5 and 9 days)

Other adverse events

Measure	HHBC and Forced Air Warming n=14 participants at risk 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. 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.
Cardiac disorders Atrial Fibrillation	35.7% 5/14 • Number of events 5 • From ICU admission to hospital discharge (ranged between 5 and 9 days)
Renal and urinary disorders Urinary Tract Infection	7.1% 1/14 • Number of events 1 • From ICU admission to hospital discharge (ranged between 5 and 9 days)
Cardiac disorders Complete Heart Block	7.1% 1/14 • Number of events 1 • From ICU admission to hospital discharge (ranged between 5 and 9 days)
Respiratory, thoracic and mediastinal disorders COPD exacerbation	7.1% 1/14 • Number of events 1 • From ICU admission to hospital discharge (ranged between 5 and 9 days)

Additional Information

Negmeldeen Mamoun, M.D.

Duke University

Phone: 919-681-3551

Email: negmeldeen.mamoun@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place