HypothermiaNCT02905708
Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia
A study testing Air-Activated heating packs and Forced Air Warming Device in people with Hypothermia, run by Dr K Services PC at 1 site in United States.
Trial summary
Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative, Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack Construction, With a View to Maintaining Normothermia During the Peri-operative Period Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Air-Activated heating packs and Forced Air Warming Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male Female ASA physical status classification system Class I ASA physical status classification system Class II Age 18-80
Who cannot join
- ASA physical status classification system Class III -VI Body Mass Index greater than 37.0
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Warming Garment to Maintain Normothermia Using Integrated Chemical Heat Pack Construction, in the Perioperative Period, for Surgery Less Than 12 Hours Duration
Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative, Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack Construction, With a View to Maintaining Normothermia During the Peri-operative Period
Read the detailed description
Subjects will be randomized into two groups. The first group will have the standard warming devices currently used which consists of a forced air warming device. This will be applied in the form of a gown in the pre-operative area. The device is called the Bair Paws. (Subjects will either continue with this or have a separate forced air warming device applied in the operating room called a Bair Hugger.) This device is non experimental and is FDA approved and used within the hospital to keep patients warm. They will then have their temperature taken and documented by the staff at various prescribed times.
The second group will receive the warming devices being studied which consist of a jacket, pants, gloves and socks with integrated air-activated chemical heat packs. The garment is applied at least twenty minutes prior to surgery. The same warming device will be maintained in place throughout the surgery and the period of post-anesthesia.
Intraoperative period: The participants temperature will be monitored and documented at prescribed times.
Postoperative period: The participants will have temperature monitored in the post anesthesia care area. Your part in this study will last until you are admitted to your room after surgery or you change into your own clothes prior to discharge.
- Conditions
- Hypothermia
- Being tested
- Air-Activated heating packs, Forced Air Warming Device
- Keywords
- normothermia, hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-Activated heating packsDevice
Also called Garment with heat packs - iron powder and activated charcoal
The subject disrobe and will dress in a jacket, pants, gloves and socks (ensemble) which will be removed from a vacuum pack. He will be assisted by the nurse in pre-operative area. The ensemble will remain in place until the subject is fully recovered from anesthesia.
Forced Air Warming DeviceDevice
Also called forced air-warming device
forced air-warming inflatable device applied according to standard hospital protocol.
| Study group | Role | What they receive |
|---|---|---|
| Forced Air Warming Device | Active comparator | Active Comparator: Forced Air Warming Device first group will have the warming devices started in the pre-operative area. You will receive a full body forced air warming. Device is non experimental and FDA approved, used within the hospital to keep patients warm.You will then have your temperature taken and documented by the staff at various prescribed times.
Warming in the operating room: You will receive the same or a similar warming device known as a Bair Hugger and warmed IV fluids once you are in the operating room. Bair Paws or Bair Hugger will also be used in the post-anesthesia care area. Receives: Device: Forced Air Warming Device |
| Air-Activated heating packs | Active comparator | The second group will receive the study warming device which consists of a jacket, pants, gloves and socks with integrated Air-Activated heating packs. Device is supplied vacuum packed, heat packs of iron powder/activated charcoal activated by air. Device applied at least twenty minutes prior to surgery. The same device will be maintained in place throughout the surgery and the post-anesthesia period. Receives: Device: Air-Activated heating packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature, degrees Centigrade
Measurement of core body temperature, degrees Centigrade, 15 minutes intervals during above time frame.
Measured: Peri-operative period - 15 minutes before surgery to 4 hours after termination of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start1 Dec 2016
- Primary completion29 Jun 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr K Services PC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence A Kirwan, M.D., Principal investigator, Dr. K. Services P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905708
- Sponsor's protocol ID
- DrKirwan IRB#16-11
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Brandt S, Oguz R, Huttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 Dec 30.
PubMed 20042442
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Warming Garment to Maintain Normothermia Using Integrated Chemical Heat Pack Construction, in the Perioperative Period, for Surgery Less Than 12 Hours Duration
- ClinicalTrials.gov ID
- NCT02905708
- Acronym / sponsor ID
- DrKirwan IRB#16-11
- Conditions
- Hypothermia
- Keywords
- normothermia, hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr K Services PCUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of Stand-alone, Non-tethered, Self-applying Warming Garment in the Preoperative, Intraoperative and Postoperative Recovery Period; Using an Integrated Chemical Heat Pack Construction, With a View to Maintaining Normothermia During the Peri-operative Period
Detailed description
Subjects will be randomized into two groups. The first group will have the standard warming devices currently used which consists of a forced air warming device. This will be applied in the form of a gown in the pre-operative area. The device is called the Bair Paws. (Subjects will either continue with this or have a separate forced air warming device applied in the operating room called a Bair Hugger.) This device is non experimental and is FDA approved and used within the hospital to keep patients warm. They will then have their temperature taken and documented by the staff at various prescribed times.
The second group will receive the warming devices being studied which consist of a jacket, pants, gloves and socks with integrated air-activated chemical heat packs. The garment is applied at least twenty minutes prior to surgery. The same warming device will be maintained in place throughout the surgery and the period of post-anesthesia.
Intraoperative period: The participants temperature will be monitored and documented at prescribed times.
Postoperative period: The participants will have temperature monitored in the post anesthesia care area. Your part in this study will last until you are admitted to your room after surgery or you change into your own clothes prior to discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forced Air Warming Device | Active comparator | Device: Forced Air Warming DeviceActive Comparator: Forced Air Warming Device first group will have the warming devices started in the pre-operative area. You will receive a full body forced air warming. Device is non experimental and FDA approved, used within the hospital to keep patients warm.You will then have your temperature taken and documented by the staff at various prescribed times. Warming in the operating room: You will receive the same or a similar warming device known as a Bair Hugger and warmed IV fluids once you are in the operating room. Bair Paws or Bair Hugger will also be used in the post-anesthesia care area. |
| Air-Activated heating packs | Active comparator | Device: Air-Activated heating packsThe second group will receive the study warming device which consists of a jacket, pants, gloves and socks with integrated Air-Activated heating packs. Device is supplied vacuum packed, heat packs of iron powder/activated charcoal activated by air. Device applied at least twenty minutes prior to surgery. The same device will be maintained in place throughout the surgery and the post-anesthesia period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male Female ASA physical status classification system Class I ASA physical status classification system Class II Age 18-80
Key exclusion criteria (1 listed)
- ASA physical status classification system Class III -VI Body Mass Index greater than 37.0
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 |
|---|---|---|
| Air-Activated heating packsAlso: Garment with heat packs - iron powder and activated charcoalThe subject disrobe and will dress in a jacket, pants, gloves and socks (ensemble) which will be removed from a vacuum pack. He will be assisted by the nurse in pre-operative area. The ensemble will remain in place until the subject is fully recovered from anesthesia. | Device | Air-Activated heating packs |
| Forced Air Warming DeviceAlso: forced air-warming deviceforced air-warming inflatable device applied according to standard hospital protocol. | Device | Forced Air Warming Device |
Primary outcome
Core body temperature, degrees Centigrade
Time frame: Peri-operative period - 15 minutes before surgery to 4 hours after termination of surgery.
Measurement of core body temperature, degrees Centigrade, 15 minutes intervals during above time frame.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Results publication: PubMed 20042442Brandt S, Oguz R, Huttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 Dec 30.
- Individual participant dataSharing planned: Undecided
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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.
Laurence A Kirwan, M.D. principal investigator
Dr. K. Services P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air-Activated heating packs and Forced Air Warming Device in people with Hypothermia, run by Dr K Services PC 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 1 inclusion and 1 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 14 Sep 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Core body temperature, degrees Centigrade (time frame: Peri-operative period - 15 minutes before surgery to 4 hours after termination of surgery.). 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 NCT02905708, which also lists 1 linked publication.
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 14 Sep 2017.