Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming
|Surgery||Device: a forced-air warming cover Device: vital HEAT (vH2) Temperature Management System|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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|
- Intraoperative Distal Esophageal (Core) Temperature [ Time Frame: at 1 hour ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Vital Heat
Vital HEAT (vH2) Temperature Management System
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: Forced air
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815191
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|