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OpenTrials
Completed

NCT Number: NCT00815191

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

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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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a forced-air warming cover

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.

vital HEAT (vH2) Temperature Management System

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.

Primary outcomes

  1. Intraoperative Distal Esophageal (Core) Temperature

    Time frame: at 1 hour

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 29, 2008
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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