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

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ClinicalTrials.gov Identifier: NCT03790683
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Advanced Cooling Therapy, LLC

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
Hypothermia Following Anesthesia Hypothermia Surgery Device: EnsoETM Device: Surface Warming Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, 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 : February 11, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

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 Name: ECD02, Esophageal Cooling Device

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




Primary Outcome Measures :
  1. Inadvertent hypothermia prevention [ Time Frame: 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 [ Time Frame: perioperative, approximately 3-12 hours ]
    Units of blood transfused during the procedure

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

  3. PACU Temperature [ Time Frame: From approximately 10-30 minutes after patient is transferred from the OR ]
    Patient core temperature reading on arrival in PACU

  4. Patient Comfort [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790683


Contacts
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Contact: Melissa I Naiman, PhD 773-615-0855 mnaiman@attune-medical.com
Contact: Erik B Kulstad, MD 708-651-0736 ekulstad@attune-medical.com

Locations
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United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Marc Torjman, PhD       marc.torjman@jefferson.edu   
Contact: Jennifer Lessin, BA, RN, CCRC       jennifer.lessin@jefferson.edu   
Principal Investigator: Coleen Vernick, DO         
Sub-Investigator: Eric Schwenk, MD         
Sub-Investigator: Michael Mahla, MD         
Sub-Investigator: Mark Berguson, MD         
Sub-Investigator: Marc C Torjman, MD         
Sponsors and Collaborators
Advanced Cooling Therapy, LLC
Thomas Jefferson University
Investigators
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Principal Investigator: Coleen Vernick, DO Thomas Jefferson University

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Responsible Party: Advanced Cooling Therapy, LLC
ClinicalTrials.gov Identifier: NCT03790683     History of Changes
Other Study ID Numbers: TJ Intraoperative warming
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Advanced Cooling Therapy, LLC:
intraoperative hypothermia
inadvertent hypothermia
perioperative hypothermia

Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms