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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

December 24, 2008
February 16, 2011
January 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00815191 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Surgery
  • 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.
  • 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: 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.
    Intervention: Device: vital HEAT (vH2) Temperature Management System
  • 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.
    Intervention: Device: a forced-air warming cover
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00815191
07-1042
No
Daniel I. Sessler, Cleveland Clinic
Outcomes Research Consortium
Not Provided
Not Provided
Outcomes Research Consortium
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP