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

NCT03697122 | Completed Results FDA Device

• 1 other identifier: Pro00100711
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Rewarming

Keywords

Cardiopulmonary bypass; Afterdrop; Deep Hypothermic Circulatory Arrest; Heated Humidified Breathing Circuit

Outcome Measures

Primary Outcomes (1)

• Time to Normothermia

  Core temperature normothermia defined as \>=36.5 C.

  up to 24 hours post admission to intensive care unit

Secondary Outcomes (8)

• 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

• 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 Prothrombin Time

  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

Study Arms (1)

HHBC and Forced Air Warming

EXPERIMENTAL

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.

Device: Heated Humidified Breathing Circuit and Forced Air Blanket

Interventions

Heated Humidified Breathing Circuit and Forced Air Blanket DEVICE

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.

Also known as: ANAPOD

HHBC and Forced Air Warming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to intensive care unit following surgical procedure involving cardiopulmonary bypass.
• Admission temperature ≤ 35.0 C.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Negmeldeen Mamoun, M.D.
• Organization: Duke University

negmeldeen.mamoun@duke.edu

919-681-3551

Study Officials

• Negmeldeen Mamoun, MD

  Duke Univeristy Hospital Anesthesia Department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 5, 2018
• Study Start: April 1, 2019
• Primary Completion: June 15, 2019
• Study Completion: June 15, 2019
• Last Updated: July 15, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-07

Locations

US (1)