Trial Outcomes & Findings for Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming (NCT NCT00815191)

NCT ID: NCT00815191

Last Updated: 2016-07-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 73 participants
• Primary outcome timeframe: at 1 hour
• Results posted on: 2016-07-18

Participant Flow

Participant milestones

Measure	Warm-water Sleeve 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. 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.	Forced Air 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. 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.
Overall Study STARTED	38	35
Overall Study COMPLETED	37	34
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Warm-water Sleeve 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. 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.	Forced Air 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. 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.
Overall Study Protocol Violation	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Warm-water Sleeve n=37 Participants 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. 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.	Forced Air n=34 Participants 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. 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.	Total n=71 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 15 • n=5 Participants	50 years STANDARD_DEVIATION 15 • n=7 Participants	49 years STANDARD_DEVIATION 15 • n=5 Participants
Sex/Gender, Customized Female	11 participants n=5 Participants	14 participants n=7 Participants	25 participants n=5 Participants
Sex/Gender, Customized Male	23 participants n=5 Participants	18 participants n=7 Participants	41 participants n=5 Participants
Sex/Gender, Customized Missing	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized White	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants
Race/Ethnicity, Customized African American	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Unknown	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Body mass index	26.1 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants	26.3 kg/m^2 STANDARD_DEVIATION 5.3 • n=7 Participants	26.2 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants

PRIMARY outcome

Timeframe: at 1 hour

Outcome measures

Measure	Warm-water Sleeve n=37 Participants 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. 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.	Forced Air n=34 Participants 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. 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.
Intraoperative Distal Esophageal (Core) Temperature	35.96 °C Standard Error 0.081	35.87 °C Standard Error 0.085

Adverse Events

Warm-water Sleeve

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Forced Air

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Sessler

Cleveland Clinic Foundation

Phone: 216-444-4900

Email: DS@OR.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place