Evaluating Heat Transfer With the Esophageal Cooling Device

NCT02743884 | Completed

• 1 other identifier: 16-124
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be heat transfer, determined from inflow and outflow temperatures and fluid flow rate for cooling and warming modes.

Conditions

Non-cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• Mean heat transfer at cooling, kcal/h

  Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water

  15-60 minutes after intubation during elective non-cardiac surgery

• Mean heat transfer at warming, kcal/h

  Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water

  15-60 minutes after intubation during elective non-cardiac surgery

Study Arms (2)

Esophageal Cooling Device

EXPERIMENTAL

Esophageal cooling

Device: Esophageal Cooling

Esophageal Warming

EXPERIMENTAL

Esophageal warming

Device: Esophageal Warming

Interventions

Esophageal Warming DEVICE

30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.

Esophageal Warming

Esophageal Cooling DEVICE

30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.

Esophageal Cooling Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective non-cardiac surgery;
• Age 18-80 years;
• Surgery expected to last \>2 hours;
• General anesthesia with endotracheal Intubation;
• Volatile anesthesia;
• BMI \< 38 kg/m2;
• ASA physical status 1-3.

You may not qualify if:

• Weight \< 45 kg;
• Unstable blood pressure;
• Known esophageal deformity or evidence of esophageal trauma or esophageal disease that in the opinion of the attending anesthesiologist precludes safe use of ECD.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Daniel Sessler, M.D.

  Dept Chairman

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Department of Outcomes Research

Model Details: Cross-over.

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)