Study of Heat and Intravenous Fluids for Exogenous Rewarming

NCT ID: NCT02339103

Last Updated: 2018-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to compare two novel active rewarming techniques in mildly hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14 degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will prove to provide significantly superior rewarming rates than shivering alone.

Detailed Description

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Conditions

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Hypothermia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shivering only

Pt placed in sleeping bag and warmed by shivering only

Group Type NO_INTERVENTION

No interventions assigned to this group

Warmed IV fluids

2 Liter of 42 degree celsius normal saline

Group Type EXPERIMENTAL

Warmed IV fluids

Intervention Type OTHER

1 Liter of warmed IV fluids at 42 degrees celsius

Warmed perfusion pads

Warmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses

Group Type EXPERIMENTAL

Warmed perfusion pads

Intervention Type OTHER

Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses

Interventions

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Warmed IV fluids

1 Liter of warmed IV fluids at 42 degrees celsius

Intervention Type OTHER

Warmed perfusion pads

Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any healthy male or female over 18 years of age

Exclusion Criteria

* No heart/blood pressure/cholesterol medications.
* No history of Raynaud's disease or any other condition (including asthma) that could be aggravated by cold-water immersion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Grant S Lipman

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Christensen ML, Lipman GS, Grahn DA, Shea KM, Einhorn J, Heller HC. A Novel Cooling Method and Comparison of Active Rewarming of Mildly Hypothermic Subjects. Wilderness Environ Med. 2017 Jun;28(2):108-115. doi: 10.1016/j.wem.2017.02.009. Epub 2017 May 12.

Reference Type RESULT
PMID: 28506514 (View on PubMed)

Other Identifiers

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31036

Identifier Type: -

Identifier Source: org_study_id

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