Efficacy of Warming Garment in the Perioperative Period With Integrated Chemical Heat Packs to Maintain Normothermia

NCT ID: NCT02905708

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2017-08-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Forced Air Warming Device

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.

Group Type: ACTIVE_COMPARATOR

Forced Air Warming Device

Intervention Type: DEVICE

forced air-warming inflatable device applied according to standard hospital protocol.

Air-Activated heating packs

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.

Group Type: ACTIVE_COMPARATOR

Air-Activated heating packs

Intervention Type: DEVICE

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.

Interventions

Air-Activated heating packs

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.

Intervention Type: DEVICE

Forced Air Warming Device

forced air-warming inflatable device applied according to standard hospital protocol.

Intervention Type: DEVICE

Other Intervention Names

Garment with heat packs - iron powder and activated charcoal; forced air-warming device

Eligibility Criteria

Inclusion Criteria

Male Female ASA physical status classification system Class I ASA physical status classification system Class II Age 18-80

Exclusion Criteria

ASA physical status classification system Class III -VI Body Mass Index greater than 37.0

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr K Services PC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence A Kirwan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dr. K. Services P.C.

Locations

Norwalk Hospital

Norwalk, Connecticut, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20042442 (View on PubMed)

Other Identifiers

DrKirwan IRB#16-11

Identifier Type: -

Identifier Source: org_study_id