NCT02467777

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 23, 2017

Completed
Last Updated

May 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1 month

First QC Date

April 23, 2015

Results QC Date

August 17, 2016

Last Update Submit

April 5, 2017

Conditions

Keywords

orthopaedicspost-operative warming

Outcome Measures

Primary Outcomes (1)

  • Temperature

    Measured by temporal artery thermometer

    Intra-Operative

Study Arms (2)

Forced Air

ACTIVE COMPARATOR

Bair Hugger

Device: Bair Hugger

Conductive Warming

ACTIVE COMPARATOR

VitaHeat

Device: VitaHeat

Interventions

Forced Air
VitaHeatDEVICE
Conductive Warming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing orthopaedic outpatient surgeries over 18 years old

You may not qualify if:

  • allergic to material of bair hugger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Valley Orthopedics

Geneva, Illinois, 60134, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Vishal Mehta
Organization
Fox Valley Orthopaedic Institute

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

April 23, 2015

First Posted

June 10, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 11, 2017

Results First Posted

March 23, 2017

Record last verified: 2017-04

Locations