Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries

• Sponsor: Fox Valley Orthopedic Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02467777
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 50.7

Study Details

Study Description

Brief Summary

Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia	Device: Bair Hugger; Device: VitaHeat	N/A

Detailed Description

Patients will be randomized into either the Forced Air group (FA) or Conductive Heat group (CH). Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. Fifty patients will be recruited with 25 patients being randomized into each group.

In patients assigned to the FA group, a Bair Hugger (Arizant Medical, Inc., Eden Prairie, Minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). The forced-air blower will be set and activated per standard practice usually after prepping and draping.

In patients assigned to the CH group, a VitaHeat (VitaHeat, Inc, Aurora, IL) conductive heating device will be placed under the torso of the patient. The device will be set and activated per standard practice usually just after positioning of the patient on the operating table.

Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Temperatures will be recorded using a temporal artery thermometer.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Forced Air Bair Hugger	Device: Bair Hugger
Active Comparator: Conductive Warming VitaHeat	Device: VitaHeat

Outcome Measures

Primary Outcome Measures

1. Temperature [Intra-Operative]

   Measured by temporal artery thermometer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients undergoing orthopaedic outpatient surgeries over 18 years old

Exclusion Criteria:

• allergic to material of bair hugger

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fox Valley Orthopedics	Geneva	Illinois	United States	60134

Sponsors and Collaborators

• Fox Valley Orthopedic Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vishal Mehta, Orthopaedic Surgeon, Fox Valley Orthopedic Institute
• ClinicalTrials.gov Identifier: NCT02467777
• Other Study ID Numbers: 15-025
• First Posted: Jun 10, 2015
• Last Update Posted: May 11, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Vishal Mehta, Orthopaedic Surgeon, Fox Valley Orthopedic Institute: orthopaedics; post-operative warming
• Additional relevant MeSH terms: Hypothermia

Study Results

Participant Flow

Arm/Group Title	Forced Air	Conductive Warming
Arm/Group Description	Bair Hugger Bair Hugger	VitaHeat VitaHeat
Period Title: Overall Study
STARTED	23	27
COMPLETED	23	27
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Forced Air	Conductive Warming	Total
Arm/Group Description	Bair Hugger Bair Hugger	VitaHeat VitaHeat	Total of all reporting groups
Overall Participants	23	27	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 82.6%	20 74.1%	39 78%
>=65 years	4 17.4%	7 25.9%	11 22%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (11.52)	50.4 (16.15)	51.6 (14.41)
Sex: Female, Male (Count of Participants)
Female	7 30.4%	11 40.7%	18 36%
Male	16 69.6%	16 59.3%	32 64%
Region of Enrollment (participants) [Number]
United States	23 100%	27 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Temperature
Description	Measured by temporal artery thermometer
Time Frame	Intra-Operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Forced Air	Conductive Warming
Arm/Group Description	Bair Hugger Bair Hugger	VitaHeat VitaHeat
Measure Participants	23	27
Mean (Standard Deviation) [degrees celsius]	97.95 (.60)	97.64 (.58)

Adverse Events

Time Frame	1 year
Arm/Group Title	Forced Air		Conductive Warming
Arm/Group Description	Bair Hugger Bair Hugger		VitaHeat VitaHeat
All Cause Mortality
	Forced Air		Conductive Warming
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/27 (0%)
Serious Adverse Events
	Forced Air		Conductive Warming
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Forced Air		Conductive Warming
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.