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

History of Changes

Tracking Information
First Received Date ^ICMJE	December 24, 2008
Last Updated Date	February 16, 2011
Start Date ^ICMJE	January 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 24, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00815191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming
Official Title ^ICMJE	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
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Surgery
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	66
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00815191
Other Study ID Numbers ^ICMJE	07-1042
Has Data Monitoring Committee	No
Responsible Party	Daniel I. Sessler, Cleveland Clinic
Study Sponsor ^ICMJE	Outcomes Research Consortium
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Outcomes Research Consortium
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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