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

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
EnsoETM	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.
EnsoETM	Surface Warming	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.
Standard of Care	Surface Warming	Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.

Primary Outcome Measures

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

Secondary Outcome Measures