Status:
TERMINATED
Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System
Lead Sponsor:
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Collaborating Sponsors:
Thomas Jefferson University
Conditions:
Hypothermia Following Anesthesia
Hypothermia
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03790683
Start Date
February 11 2019
End Date
December 1 2021
Last Update
February 21 2023
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107