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

NCT03790683 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-02-21

Study results available
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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.

Conditions

  • Hypothermia Following Anesthesia
  • Hypothermia
  • Surgery

Interventions

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.

DEVICE

Surface Warming

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

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER

  • Advanced Cooling Therapy, Inc., d/b/a Attune Medical

    lead INDUSTRY

Principal Investigators

  • Coleen Vernick, DO · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2021-08-01
Completion
2021-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790683 on ClinicalTrials.gov