NCT03790683

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Advanced Cooling Therapy, Inc., d/b/a Attune Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Surface Warming	Forced air warming device will be placed on the patient according to standard practice.

Timeline

• Start date: 2019-02-11
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2019-01-02
• Last updated: 2023-02-21
• Results posted: 2022-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study