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

NCT ID: NCT03790683

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2021-12-01

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.

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.

Conditions

Hypothermia Following Anesthesia; Hypothermia; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EnsoETM

Intervention Type: 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.

Surface Warming

Intervention Type: DEVICE

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

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Surface Warming

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Surface Warming

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

Intervention Type: DEVICE

Other Intervention Names

ECD02, Esophageal Cooling Device; Bair Hugger, forced air blanket

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

Advanced Cooling Therapy, Inc., d/b/a Attune Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Coleen Vernick, DO

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TJ Intraoperative warming

Identifier Type: -

Identifier Source: org_study_id