Heat Stroke, Heat ExhaustionNCT01694290
Chemical Ice Packs for Cooling Hyperthermic Patients
A study testing Chemical Cold Pack in people with Heat Stroke, Heat Exhaustion, run by Stanford University at 1 site in United States.
Trial summary
A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Stroke, Heat Exhaustion
- What is being tested?
- Chemical Cold Pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2013
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- young healthy males > 18 years old with no active medical problems and able to run 10 km.
Who cannot join
- Active medical problems or inability to exercise for 45 minutes in a heated room.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Assessing Effectiveness of Chemical Cold Packs Used on Various Skin Surfaces for Cooling Hyperthermic Patients
A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.
The ability of these to cool a person has never been quantified, the efficiency and extent of cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of this study is to determine whether strategically placed chemical ice packs will provide benefit to individuals subjected to heat stress.
- Conditions
- Heat Stroke, Heat Exhaustion
- Being tested
- Chemical Cold Pack
- Medical subject headings
- Heat Stroke, Heat Exhaustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemical Cold PackOther
| Study group | Role | What they receive |
|---|---|---|
| Chemical Ice packs to neck, groin, axillae | Experimental | Chemical ice packs will be changed out every 9 minutes Receives: Other: Chemical Cold Pack |
| Chemical Ice Packs to cheeks, palms, soles | Experimental | Chemical Ice packs will be changed out every 9 minutes Receives: Other: Chemical Cold Pack |
| no chemical ice packs | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature cooling
Measured: 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
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 Heat Stroke, Heat ExhaustionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant S Lipman, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694290
- Sponsor's protocol ID
- 24308
- Status last verified
- Nov 2018
- First submitted
- 24 Sep 2012
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lissoway JB, Lipman GS, Grahn DA, Cao VH, Shaheen M, Phan S, Weiss EA, Heller HC. Novel application of chemical cold packs for treatment of exercise-induced hyperthermia: a randomized controlled trial. Wilderness Environ Med. 2015 Jun;26(2):173-9. doi: 10.1016/j.wem.2014.11.006. Epub 2015 Mar 12.
PubMed 25771030
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Assessing Effectiveness of Chemical Cold Packs Used on Various Skin Surfaces for Cooling Hyperthermic Patients
- ClinicalTrials.gov ID
- NCT01694290
- Acronym / sponsor ID
- 24308
- Conditions
- Heat Stroke, Heat Exhaustion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Sep 2012 (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.
A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.
The ability of these to cool a person has never been quantified, the efficiency and extent of cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of this study is to determine whether strategically placed chemical ice packs will provide benefit to individuals subjected to heat stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemical Ice packs to neck, groin, axillae | Experimental | Other: Chemical Cold PackChemical ice packs will be changed out every 9 minutes |
| Chemical Ice Packs to cheeks, palms, soles | Experimental | Other: Chemical Cold PackChemical Ice packs will be changed out every 9 minutes |
| no chemical ice packs | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- young healthy males > 18 years old with no active medical problems and able to run 10 km.
Key exclusion criteria (1 listed)
- Active medical problems or inability to exercise for 45 minutes in a heated room.
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 |
|---|---|---|
| Chemical Cold Pack | Other | Chemical Ice Packs to cheeks, palms, soles, Chemical Ice packs to neck, groin, axillae |
Primary outcome
Core body temperature cooling
Time frame: 35 minutes
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 26 Nov 2018.
- Results publication: PubMed 25771030Lissoway JB, Lipman GS, Grahn DA, Cao VH, Shaheen M, Phan S, Weiss EA, Heller HC. Novel application of chemical cold packs for treatment of exercise-induced hyperthermia: a randomized controlled trial. Wilderness Environ Med. 2015 Jun;26(2):173-9. doi: 10.1016/j.wem.2014.11.006. Epub 2015 Mar 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemical Cold Pack in people with Heat Stroke, Heat Exhaustion, run by Stanford University 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 26 Nov 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 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 cooling (time frame: 35 minutes). 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 NCT01694290, 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 26 Nov 2018.