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

Surgery Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Following Anesthesia
• Surgery

• NCT number: NCT03790683
• Study type: Interventional
• Source: Advanced Cooling Therapy, Inc., d/b/a Attune Medical
• Status: Terminated
• Phase: N/A
• Start date: February 11, 2019
• Completion date: December 1, 2021