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

Advanced Cooling Therapy, Inc., d/b/a Attune Medical28 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hypothermia Following Anesthesia Hypothermia Surgery

Interventions

EnsoETMDEVICE

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 WarmingDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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 frame: Time from intubation until extubation, approximately 3-12 hours

Secondary Outcomes

Time From Intubation Until Extubation

Time from intubation until extubation

Time frame: perioperative, approximately 3-12 hours

Data from ClinicalTrials.gov

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