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

NCT03790683 | Terminated Results DMC FDA Device

• 1 other identifier: TJ Intraoperative warming
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia Following Anesthesia; Hypothermia; Surgery

Keywords

intraoperative hypothermia; inadvertent hypothermia; perioperative hypothermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time From Intubation Until Extubation

  perioperative, approximately 3-12 hours

Study Arms (2)

EnsoETM

EXPERIMENTAL

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; Device: Surface Warming

Standard of Care

ACTIVE COMPARATOR

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

Device: Surface Warming

Interventions

EnsoETM DEVICE

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.

Also known as: ECD02, Esophageal Cooling Device

EnsoETM

Surface Warming DEVICE

Forced air warming device will be placed on the patient according to standard practice.

Also known as: Bair Hugger, forced air blanket

EnsoETM; Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, 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: Marc C. Torjman, Ph.D.
• Organization: Sidney Kimmel Medical College, Thomas Jefferson University and Hospitals

Marc.Torjman@Jefferson.edu

(215) 955-5275

Study Officials

• Coleen Vernick, DO

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, randomized interventional study

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 2, 2019
• Study Start: February 11, 2019
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 21, 2023
• Results First Posted: October 27, 2022

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)