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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothermia Following Anesthesia, Hypothermia, Surgery

Intervention / Treatment
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* Device: EnsoETM
* Device: Surface Warming


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EnsoETM<br>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<br>* 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.<br>* Other names: ECD02, Esophageal Cooling Device;Device: Surface Warming<br>* Forced air warming device will be placed on the patient according to standard practice.<br>* Other names: Bair Hugger, forced air blanket;|
| Active Comparator: Standard of Care<br>Participants receive standard of care surface warming from the time they enter the OR until released to the PACU. | Device: Surface Warming<br>* Forced air warming device will be placed on the patient according to standard practice.<br>* Other names: Bair Hugger, forced air blanket;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative hypothermia, inadvertent hypothermia, perioperative hypothermia