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Comparison of Intraoperative Warming Devices

Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00711867
Enrollment
55
Registered
2008-07-09
Start date
2008-07-31
Completion date
2008-12-31
Last updated
2009-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Brief summary

The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients warmed with the Arizant Bair Hugger System.

Interventions

DEVICEVH2

Dynatherm vitalHeat2 (VH2) temperature management system.

DEVICEBair Hugger

Arizant Bair Hugger temperature management system.

Sponsors

Dynatherm Medical Inc.
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Initial total knee arthroplasty. * Expected duration of surgery at least 2 hours. * General anesthesia. * American Society of Anesthesiologists (ASA) classification I-III. * Age \>= 18 years.

Exclusion criteria

* Skin abrasion at the device application site. * History of peripheral vascular disease. * History of allergic skin conditions of the upper extremities. * History of malignant hyperthermia.

Design outcomes

Primary

MeasureTime frame
Sublingual Temperature.Within 10 minutes of arrival in PACU

Countries

United States

Participant flow

Recruitment details

Patients were recruited sequentially and assigned to vitalHeat2 (VH2) or Bair Hugger temperature management at random in a 1:1 ratio.

Pre-assignment details

75 consented. 9 cancelled surgery or were rescheduled. 36 assigned to VH2 and 30 assigned to Bair Hugger. 6 excluded from VH2 group after randomization (2 vacuum not established, 2 research staff not available, 2 arterial line used). 5 excluded from Bair Hugger group after randomization (4 laryngeal mask airway used, 1 epidural anesthesia used).

Participants by arm

ArmCount
VH2 Temperature Management
Dynatherm vitalHeat2 (VH2) temperature management system.
30
Bair Hugger Temperature Management
Arizant Bair Hugger temperature management system.
25
Total55

Baseline characteristics

CharacteristicVH2 Temperature ManagementBair Hugger Temperature ManagementTotal
Age Continuous68.9 years
STANDARD_DEVIATION 11.4
67.0 years
STANDARD_DEVIATION 9.4
68.0 years
STANDARD_DEVIATION 10.5
Sex: Female, Male
Female
18 Participants13 Participants31 Participants
Sex: Female, Male
Male
12 Participants12 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 25
serious
Total, serious adverse events
0 / 300 / 25

Outcome results

Primary

Sublingual Temperature.

Time frame: Within 10 minutes of arrival in PACU

Population: Per protocol.

ArmMeasureValue (MEAN)Dispersion
VH2 Temperature ManagementSublingual Temperature.36.38 CStandard Deviation 0.38
Bair Hugger Temperature ManagementSublingual Temperature.36.73 CStandard Deviation 0.29
Comparison: H0: Mu\_VH - Mu\_BH \<= -0.5 C.95% CI: [-0.55, -0.14]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026