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

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.

Study Overview

• Status: Terminated
• Conditions: Surgery; Hypothermia; Hypothermia Following Anesthesia
• Intervention / Treatment: Device: EnsoETM; Device: Surface Warming

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EnsoETM; Participants receive esophageal warming. Original study design anticipated esophageal warming in addition to standard of care surface warming from the time they enter the OR until released to the PACU. After 7 patients, protocol was adjusted to specify only esophageal warming unless addition of surface warming was warranted.	Device: EnsoETM; Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia. Addition of standard of care surface warming was specified as optional after first 7 patients.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inadvertent Hypothermia Prevention	Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.	Time from intubation until extubation, approximately 3-12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Intubation Until Extubation	Time from intubation until extubation	perioperative, approximately 3-12 hours

Collaborators and Investigators

• Sponsor: Advanced Cooling Therapy, Inc., d/b/a Attune Medical
• Collaborators: Thomas Jefferson University
• Investigators: Principal Investigator: Coleen Vernick, DO, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: perioperative hypothermia; intraoperative hypothermia; inadvertent hypothermia
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: TJ Intraoperative warming

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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