Perioperative HypothermiaPhase 4NCT01626690

Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients

A Phase 4 study testing Bair-Paws Warming Device and Bair-Hugger Warming Device in people with Perioperative Hypothermia, run by University of Wisconsin, Madison at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine if placement of a forced-air warming device prior to institution of regional anesthesia improves perioperative temperature control in patients undergoing total hip arthroplasty. Read more about this study

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Perioperative Hypothermia
What is being tested?: Bair-Paws Warming Device and Bair-Hugger Warming Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: May 2012to Dec 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients undergoing total hip arthroplasty under neuraxial anesthesia,
age 55-85,
BMI 18-40

Who cannot join

allergy to local anesthetics,
patients electing to have general anesthesia for their total hip arthroplasty,
pregnancy,
prisoners,
patients unable to give informed consent,
English as a second language,
active infectious or febrile illness (measured temperature > 37.5 degrees Celsius).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Prospective Randomized Control Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients

Conditions: Perioperative Hypothermia
Being tested: Bair-Paws Warming Device, Bair-Hugger Warming Device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bair-Paws Warming DeviceDevice
Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
Bair-Hugger Warming DeviceDevice
Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).

Study groups in NCT01626690
Study group	Role	What they receive
Pre-Warming	Experimental	Not described Receives: Device: Bair-Paws Warming Device
Control	Active comparator	Not described Receives: Device: Bair-Hugger Warming Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.
Measured: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).

Secondary outcomes (7)

Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.
Measured: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.
Measured: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.
Measured: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Incidence of Postoperative Shivering in Recovery Room.
Measured: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Intraoperative Blood Loss.
Intraoperative blood loss in mL's.
Measured: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Incidence of Perioperative Cardiac Events.
Incidence of perioperative arrhythmias or myocardial ischemia.
Measured: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Temporal Artery Verus SpotOn (3M) Temperature Readings.
Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.
Measured: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Dec 2014

First posted25 Jun 2012 (estimated)
Study startMay 2012
Primary completionDec 2014
Study completionDec 2014

Why it stopped: Surgeons change in preference for perioperative warming.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Perioperative HypothermiaStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01626690
Sponsor's protocol ID: 2011-0823
Status last verified: Jul 2016
First submitted: 12 Jun 2012
Last updated: 15 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Prewarming Duration on Blood Flow After Colon Resection Surgery
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Goal-Directed Temperature Management During Prolonged Abdominal Surgery
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Agreement Among Three Methods of Intraoperative Core Temperature Monitoring: Nasopharyngeal Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Skin Sensor
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All Perioperative Hypothermia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Control Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
ClinicalTrials.gov ID: NCT01626690
Acronym / sponsor ID: 2011-0823
Conditions: Perioperative Hypothermia
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Surgeons change in preference for perioperative warming.
Enrolment: 100 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: May 2012
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 25 Jun 2012 (estimated)
Results: Posted 15 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pre-Warming	Experimental	Device: Bair-Paws Warming Device
Control	Active comparator	Device: Bair-Hugger Warming Device

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

patients undergoing total hip arthroplasty under neuraxial anesthesia,
age 55-85,
BMI 18-40

Key exclusion criteria (7 listed)

allergy to local anesthetics,
patients electing to have general anesthesia for their total hip arthroplasty,
pregnancy,
prisoners,
patients unable to give informed consent,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bair-Paws Warming DeviceBair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.	Device	Pre-Warming
Bair-Hugger Warming DeviceBair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).	Device	Control

Primary outcome

Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.

7 secondary outcomes

Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Incidence of Postoperative Shivering in Recovery Room.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Intraoperative Blood Loss.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Incidence of Perioperative Cardiac Events.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Temporal Artery Verus SpotOn (3M) Temperature Readings.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).

Results and safety

Results posted to the registry on 15 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-Warming	49	47
Control	51	51

Primary outcome: Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..

Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).. Mean (Standard Deviation). Unit: Degrees Celsius

Measure	Pre-Warming n = 47	Control n = 51
Value	35.7 (0.47)	35.4 (0.49)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-Warming	0 of 47 (0%)	0 of 47 (0%)	Not reported
Control	0 of 51 (0%)	0 of 51 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Perioperative Hypothermia

Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
Not yet recruiting
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, Inadvertent Perioperative Hypothermia
Not yet recruiting
Effect of Prewarming Duration on Blood Flow After Colon Resection Surgery
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Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
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Not yet recruitingObservational study
Agreement Among Three Methods of Intraoperative Core Temperature Monitoring: Nasopharyngeal Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Skin Sensor
Intraoperative Temperature Monitoring, Body Temperature

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bair-Paws Warming Device and Bair-Hugger Warming Device in people with Perioperative Hypothermia, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System.. (time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01626690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.