NCT02905708

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

September 6, 2016

Last Update Submit

September 13, 2017

Conditions

Hypothermia

Keywords

normothermiahypothermia

Outcome Measures

Primary Outcomes (1)

  • Core body temperature, degrees Centigrade

    Measurement of core body temperature, degrees Centigrade, 15 minutes intervals during above time frame.

    Peri-operative period - 15 minutes before surgery to 4 hours after termination of surgery.

Study Arms (2)

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.

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.

Device: Air-Activated heating packs

Interventions

Air-Activated heating packsDEVICE

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.

Also known as: Garment with heat packs - iron powder and activated charcoal
Air-Activated heating packs
Forced Air Warming DeviceDEVICE

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

Also known as: forced air-warming device
Forced Air Warming Device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Related Publications (1)

  • 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.

    PMID: 20042442RESULT

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laurence A Kirwan, M.D.

    Dr. K. Services P.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 19, 2016

Study Start

December 1, 2016

Primary Completion

June 29, 2017

Study Completion

August 31, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(1)