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

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: vital HEAT (vH2) Temperature Management System; Device: a forced-air warming cover

• Registration Number: NCT00815191
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2008-12-24
• Study First Posted: 2008-12-29
• Results First Submitted: 2016-02-27
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-07
• Last Update Submitted: 2016-06-07
• Results First Posted: 2016-07-18
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vital Heat	vital HEAT (vH2) Temperature Management System	Vital HEAT (vH2) Temperature Management System
Forced air	a forced-air warming cover	Forced-air warming

Primary Outcome Measures

Name	Time	Method
Intraoperative Distal Esophageal (Core) Temperature	at 1 hour

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States