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Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System

Sponsor
Advanced Cooling Therapy, Inc., d/b/a Attune Medical (Industry)
Overall Status
Terminated
CT.gov ID
NCT03790683
Collaborator
Thomas Jefferson University (Other)
28
Enrollment
1
Location
2
Arms
33.6
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess the effectiveness of EnsoETM as a supplemental warming device compared to the standard of care warming practice in patients having major surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: EnsoETM
  • Device: Surface Warming
 N/A

Detailed Description

Maintaining patient's body temperature is of major importance in patients undergoing surgical procedures and existing methods to warm patients to maintain perioperative normothermia have limitations. This results in as many as half of patients undergoing surgery developing inadvertent hypothermia during and/or after their procedure. The EnsoETM is an Esophageal Temperature Management (ETM) device consisting of a multi-chambered silicone tube connected to a heat exchanger and placed in the esophagus, providing highly efficient heat transfer to a patient. The EnsoETM potentially improves the ability to control patient temperature by eliminating the disadvantages of existing methods while maintaining the functionality of the orogastric tube that it replaces.

The primary objective of this study is to measure the number of degree-hours spent below 37°C intraoperatively and until recovery in the PACU. This measure will be compared between patients having standard management of body temperature to patients having the EnsoETM placed as an additional warming device.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective, randomized interventional studyprospective, randomized interventional study
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System
Actual Study Start Date :
Feb 11, 2019
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: EnsoETM + Standard of Care

Participants receive esophageal warming in addition to standard of care surface warming from the time they enter the OR until released to the PACU.

Device: EnsoETM
Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia in addition to standard of care surface warming.
Other Names:
  • ECD02, Esophageal Cooling Device

    • Device: Surface Warming
    Forced air warming device will be placed on the patient according to standard practice.
    Other Names:
  • Bair Hugger, forced air blanket

    		•
    Active Comparator: Standard of Care

    Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.

    Device: Surface Warming
    Forced air warming device will be placed on the patient according to standard practice.
    Other Names:
  • Bair Hugger, forced air blanket

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Inadvertent hypothermia prevention [Time from intubation until extubation, approximately 3-12 hours]

      Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.

    Secondary Outcome Measures

    1. Units of blood transfused [perioperative, approximately 3-12 hours]

      Units of blood transfused during the procedure

    2. Time from intubation until extubation [perioperative, approximately 3-12 hours]

      Time from intubation until extubation

    3. PACU Temperature [From approximately 10-30 minutes after patient is transferred from the OR]

      Patient core temperature reading on arrival in PACU

    4. Patient Comfort [From PACU admission until PACU discharge, approximately 2-4 hours]

      Routine pain score measured on the Numerical Rating Pain Scale from 1-10, with 10 being most intense pain possible. Collected approximately every 30 minutes, or more frequently if patient reports severe pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Provision of signed and dated informed consent form

    • Male or female, ages 18 years and older

    • Scheduled for major surgical procedures requiring general anesthesia and with no known contraindication to having an orogastric tube placed for the duration of the surgery

    • The time in the OR is expected to last at least 180 minutes

    Exclusion Criteria:

    • Esophageal strictures (risk of perforation)

    • Patients with known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia, etc.)

    • Known ingestion of acidic or caustic poisons within the prior 24 hours.

    • Patients with <40 kg of body mass

    • Coagulopathy

    • Severe facial trauma

    • Surgical procedures lasting less than 3 hours

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Advanced Cooling Therapy, Inc., d/b/a Attune Medical
    • Thomas Jefferson University

    Investigators

    • Principal Investigator: Coleen Vernick, DO, Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Advanced Cooling Therapy, Inc., d/b/a Attune Medical
    ClinicalTrials.gov Identifier:
    NCT03790683
    Other Study ID Numbers:
    • TJ Intraoperative warming
    First Posted:
    Jan 2, 2019
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Advanced Cooling Therapy, Inc., d/b/a Attune Medical
    intraoperative hypothermia
    inadvertent hypothermia
    perioperative hypothermia
    Additional relevant MeSH terms:
    Hypothermia

    Study Results

    No Results Posted as of Feb 1, 2022