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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03790683
• Other study ID #: TJ Intraoperative warming
• Status: Terminated
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2023
• Source: Advanced Cooling Therapy, Inc., d/b/a Attune Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Following Anesthesia
• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Cooling Therapy, Inc., d/b/a Attune Medical	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time From Intubation Until Extubation	Time from intubation until extubation	perioperative, approximately 3-12 hours