Clinical trial NCT03790683: Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System
Official title: Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypothermia Following Anesthesia
Hypothermia
Surgery
Keywords: intraoperative hypothermia
inadvertent hypothermia
perioperative hypothermia
Lead sponsor: Advanced Cooling Therapy LLC, d/b/a Attune Medical
Sponsor class: INDUSTRY
Collaborators: name: Thomas Jefferson University
First posted: 2019-01-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized interventional study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inadvertent Hypothermia Prevention
timeFrame: Time from intubation until extubation, approximately 3-12 hours
Secondary outcomes:
measure: Time From Intubation Until Extubation
timeFrame: perioperative, approximately 3-12 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Coleen Vernick, DO
role: PRINCIPAL_INVESTIGATOR
References: