Trial Outcomes & Findings for Comparison of Intraoperative Warming Devices (NCT NCT00711867)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

55 participants

Primary outcome timeframe

Within 10 minutes of arrival in PACU

Results posted on

2009-12-15

Participant Flow

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

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).

Participant milestones

Participant milestones
Measure	VH2 Temperature Management Dynatherm vitalHeat2 (VH2) temperature management system.	Bair Hugger Temperature Management Arizant Bair Hugger temperature management system.
Overall Study STARTED	30	25
Overall Study COMPLETED	25	21
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Intraoperative Warming Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VH2 Temperature Management n=30 Participants Dynatherm vitalHeat2 (VH2) temperature management system.	Bair Hugger Temperature Management n=25 Participants Arizant Bair Hugger temperature management system.	Total n=55 Participants Total of all reporting groups
Age Continuous	68.9 years STANDARD_DEVIATION 11.4 • n=5 Participants	67.0 years STANDARD_DEVIATION 9.4 • n=7 Participants	68.0 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 10 minutes of arrival in PACU

Population: Per protocol.

Outcome measures

Outcome measures
Measure	VH2 Temperature Management n=25 Participants Dynatherm vitalHeat2 (VH2) temperature management system.	Bair Hugger Temperature Management n=21 Participants Arizant Bair Hugger temperature management system.
Sublingual Temperature.	36.38 C Standard Deviation 0.38	36.73 C Standard Deviation 0.29

Adverse Events

VH2 Temperature Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bair Hugger Temperature Management

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

Terrence L Trentman MD

Mayo Clinic

Phone: 480-301-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60