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

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00815191
First received: December 24, 2008
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Surgery
Device: a forced-air warming cover
Device: vital HEAT (vH2) Temperature Management System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • To determine if intraoperative distal esophageal (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in patients undergoing open abdominal procedures [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.
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: 2
Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815191

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
  More Information

No publications provided

Responsible Party: Daniel I. Sessler, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00815191     History of Changes
Other Study ID Numbers: 07-1042
Study First Received: December 24, 2008
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
temperature
surgery
heating device

ClinicalTrials.gov processed this record on November 25, 2014