SurgeryNCT00715728

Efficacy of Warming Device During Surgery

An observational study of Surgery, run by The Cleveland Clinic at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will test the hypothesis that an electric heating device, the Hot Dog warming system is as effective as the Bair Hugger forced air heating system. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgery
What is being tested?: Intraoperative warming with Bair Hugger forced air system and Intraoperative warming with Hotdog resistive heating system
Type of treatment: Medical device
How many people: 28 participants
Where: 1 siteAustria
Study dates: Jun 2008to Dec 2009
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing major plastic surgery lasting approximately 5 hours.

Who may be able to join

Plastic surgery lasting approximately 5 hours
Subjects over the age of 18 years
Patient signed Informed Consent

Who cannot join

Plastic surgery lasting less than 5 hours
Individuals under the age of 18 years

Trial locations and contacts

1 site in 1 country.

Austria1 site

Vienna General Hospital/University of Vienna
Vienna

Other trials in Austria

About this study

Official title: Efficacy of a New Intraoperative Resistive Warming Device

This study will test the hypothesis that an electric heating device, the Hot Dog warming system is as effective as the Bair Hugger forced air heating system.

Read the detailed description

Subjects undergoing major plastic surgery lasting approximately 5 hours will be randomized to either the Hot Dog resistive heating system or the Bair Hugger forced air heating system. Core temperature will be measured using a distal esophagus and mean skin temperature. Warming will continue until the subjects' core temperature reaches 37°C. Subsequent temperature will be adjusted as clinically necessary. Data will be recorded at 15 minute intervals. Core temperature will be first measured after intubation when the esophageal temperature probe is inserted. The primary outcome will be the rate of core rewarming over the range of 35°C to 37°C.

Conditions: Surgery
Being tested: Intraoperative warming with Bair Hugger forced air system, Intraoperative warming with Hotdog resistive heating system
Keywords: Plastic surgery, Warming, Core temperature, Bair Hugger, Hot Dog heating system

What participants receive

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

Intraoperative warming with Bair Hugger forced air systemDevice
Intraoperative warming with Bair Hugger forced air system
Intraoperative warming with Hotdog resistive heating systemDevice
Intraoperative warming with Hotdog resistive heating system

Study groups in NCT00715728
Study group	Role	What they receive
1: Bair Hugger		Intraoperative warming with Bair Hugger forced air system Receives: Device: Intraoperative warming with Bair Hugger forced air system
2: Hot Dog		Intraoperative warming with Hot Dog resistive heating system Receives: Device: Intraoperative warming with Hotdog resistive heating system

What is being measured

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

The Rate of Core Rewarming Over the Range From 35°C to 37°C.
The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.
Measured: Until the end of surgery, up to 5 hour
Intraoperative Time Weighted Average Core Temperature
Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.
Measured: Until the end of surgery, up to 5 hour

Timeline

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

Jun 2008Dec 2009

First posted15 Jul 2008 (estimated)
Study startJun 2008
Primary completionDec 2009
Study completionDec 2009

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 SurgeryStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00715728
Sponsor's protocol ID: IRWS
Status last verified: Apr 2017
First submitted: 11 Jul 2008
Last updated: 16 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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All Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of a New Intraoperative Resistive Warming Device
ClinicalTrials.gov ID: NCT00715728
Acronym / sponsor ID: IRWS
Conditions: Surgery
Keywords: Plastic surgery, Warming, Core temperature, Bair Hugger, Hot Dog heating system
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: Jun 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 15 Jul 2008 (estimated)
Results: Posted 16 Jul 2018

Clinical summary

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

This study will test the hypothesis that an electric heating device, the Hot Dog warming system is as effective as the Bair Hugger forced air heating system.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
1: Bair Hugger	–	Device: Intraoperative warming with Bair Hugger forced air systemIntraoperative warming with Bair Hugger forced air system
2: Hot Dog	–	Device: Intraoperative warming with Hotdog resistive heating systemIntraoperative warming with Hot Dog resistive heating system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing major plastic surgery lasting approximately 5 hours.

Key inclusion criteria (3 listed)

Plastic surgery lasting approximately 5 hours
Subjects over the age of 18 years
Patient signed Informed Consent

Key exclusion criteria (2 listed)

Plastic surgery lasting less than 5 hours
Individuals under the age of 18 years

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
Intraoperative warming with Bair Hugger forced air systemIntraoperative warming with Bair Hugger forced air system	Device	1: Bair Hugger
Intraoperative warming with Hotdog resistive heating systemIntraoperative warming with Hotdog resistive heating system	Device	2: Hot Dog

Primary outcome

The Rate of Core Rewarming Over the Range From 35°C to 37°C.
Time frame: Until the end of surgery, up to 5 hour
The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.
Intraoperative Time Weighted Average Core Temperature
Time frame: Until the end of surgery, up to 5 hour
Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.

Results and safety

Results posted to the registry on 16 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intra-operative Rewarming With Bair Hugger Heating	14	14
Intraoperative Rewarming With Hot Dog Resistive Heating	14	14

Primary outcome: The Rate of Core Rewarming Over the Range From 35°C to 37°C.

Time frame: Until the end of surgery, up to 5 hour. Mean (Standard Error). Unit: degrees Celcius / hr

Measure	Intra-operative Rewarming With Hot Dog n = 14	Intra-operative Rewarming With Forced-air Heating n = 14
Value	.24 (.025)	.49 (.027)

Intra-operative Rewarming With Hot Dog vs Intra-operative Rewarming With Forced-air Heating: p = 0.91, t-test, 1 sided
Intra-operative Rewarming With Hot Dog vs Intra-operative Rewarming With Forced-air Heating: p <0.001, t-test, 1 sided

Primary outcome: Intraoperative Time Weighted Average Core Temperature

Time frame: Until the end of surgery, up to 5 hour. Mean (Standard Error). Unit: degrees as measured in Celcius

Measure	Intraoperative Warming With Bair Hugger Forced Air System n = 14	Intraoperative Warming With Hot Dog Resistive Heating System n = 14
Value	36.24 (0.27)	36.12 (0.25)

Intraoperative Warming With Bair Hugger Forced Air System vs Intraoperative Warming With Hot Dog Resistive Heating System: Mean Difference (Final Values): -0.12 (95% CI -0.37 to 0.14), p = 0.018, t-test, 1 sided

Population analysed: Medical University of Vienna adults having major maxillary-facial reconstructive surgery expected to last about 5 h. Most had pectoral flap reconstructions after extensive cancer debridement. We did not study patients with Reynaud's disease, thyroid dysfunction, insulin-dependent diabetes mellitus, or who were of ASA physical status \> 3.

Adverse events

Time frame: From the beginning of the surgery until the end of surgery, up to 24 hour.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bair Hugger Forced Air System	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Hot Dog Resistive Heating System	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): Unable to evaluate safety with small sample size. Smaller-than-expected sample size had enough power but confidence intervals for treatment effect wider than desired.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Surgery

RecruitingPhase 4
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Laparoscopic Surgery, Visceral Pain, Postoperative
RecruitingPhase 1
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Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruitingObservational study
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Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
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Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
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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.

Olga Plattner, MD principal investigator

Medical University of Vienna

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

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery, run by The Cleveland Clinic at 1 site in Austria.

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 2 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: finished, as of the sponsor's last update on 16 Jul 2018. 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 Austria. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2018). 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?

The Rate of Core Rewarming Over the Range From 35°C to 37°C. (time frame: Until the end of surgery, up to 5 hour). The study lists 2 primary outcomes in all. 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 NCT00715728.

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 16 Jul 2018.