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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vital Heat

Vital HEAT (vH2) Temperature Management System

Group Type ACTIVE_COMPARATOR

vital HEAT (vH2) Temperature Management System

Intervention Type DEVICE

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.

Forced air

Forced-air warming

Group Type ACTIVE_COMPARATOR

a forced-air warming cover

Intervention Type DEVICE

A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No