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

Advanced Cooling Therapy (Attune Medical)

Status: Terminated

Conditions: Hypothermia Following Anesthesia; Surgery; Hypothermia

Treatments: Device: EnsoETM; Device: Surface Warming

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03790683

TJ Intraoperative warming

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

EnsoETM

Experimental group

Description:

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.

Treatment:

Device: Surface Warming

Device: EnsoETM

Standard of Care

Active Comparator group

Description:

Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.

Treatment:

Device: Surface Warming