Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming

A Comparison Study of the Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming in Patients Undergoing Open Abdominal Surgery Under General Anesthesia

The primary objective of this study is to determine if the intraoperative distal esophageal (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in patients undergoing open colectomy under general anesthesia. This is a randomized study.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: vital HEAT (vH2) Temperature Management System; Device: a forced-air warming cover

Detailed Description

Participants will be randomized into one of two groups. Patients assigned to vitalHEAT warming will have the circulating-water sleeve applied to an arm that will not require intravenous access. An esophageal temperature probe will be inserted and connected to the anesthesia machine monitoring system. Intravenous fluids will be warmed to 40-42°C.

As soon as practical after induction, the vitalHEAT warmer will be activated in the appropriate patients and set to "high" which is 42°C

An upper-body forced-air warmer will be positioned over the upper body and exposed arms on patients assigned to forced-air heating. The forced air blower will be set to "high" which is 43°C and activated as soon as practical, usually after prepping and draping.

Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Active warming will be maintained until just before extubation. The esophageal temperature probe will be removed, and the patient extubated after emergence from anesthesia. This will conclude the study and subsequent management will be at the discretion of the attending anesthesiologist

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body-mass index 20-36 kg/m2;
• Age 18-75 yrs;
• ASA Physical Status 1-3.

Exclusion Criteria:

• Patient requires an intravenous or arterial catheter distal to the elbow on both arms;
• Serious skin lesions on the hands or arms;
• History of serious vascular disease in the arms;
• Pre-operative fever;
• Contraindication to sevoflurane endotracheal anesthesia.
• Pre-existing neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vital Heat; Vital HEAT (vH2) Temperature Management System	Device: vital HEAT (vH2) Temperature Management System; The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery.
Active Comparator: Forced air; Forced-air warming	Device: a forced-air warming cover; A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative Distal Esophageal (Core) Temperature	at 1 hour

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 24, 2008
• First Submitted That Met QC Criteria: December 24, 2008
• First Posted (Estimate): December 29, 2008

Study Record Updates

• Last Update Posted (Estimate): July 18, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: surgery; temperature; heating device
• Other Study ID Numbers: 07-1042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No