StrokeCryoCollarNCT02703675
Effectiveness, Safety and Ease of Application of Excel Cryo Cooling Collar to Rapidly Reduce Core Brain Temperature
A study testing Excel Cryo Cooling Collar in people with Stroke, run by Michel Torbey at 1 site in United States.
Trial summary
Research has shown that lowering brain temperature may have good results in heart attack patients. Lowering brain temperature may be a promising treatment for stroke patients. The Excel Cryo Cooling device drops brain temperature by cooling the blood in arteries in the neck. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Excel Cryo Cooling Collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 12 Jun 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18-60 years of age
- Computed Tomography Angiography (CTA) image results show no narrow in carotid artery (not applied to healthy volunteers)
- Be able to accept cooling procedure at least 2 hours
- Provide informed consent.
Who cannot join
- Patients with increased intracerebral pressure (ICP), intracerebral hemorrhage (ICH) and carotid artery stenosis
- Receiving external ventricular drainage
- Taking anti-febrile medications within 4 hours
- Females who are pregnant or breastfeeding
- Subjects who have arrhythmia, other serious cardiac disease, or low blood pressure
- Subject has a higher body mass index (BMI>35)
- Receiving jugular IV catheter
- Skin wound around the neck
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Research has shown that lowering brain temperature may have good results in heart attack patients. Lowering brain temperature may be a promising treatment for stroke patients. The Excel Cryo Cooling device drops brain temperature by cooling the blood in arteries in the neck. The device is a neck collar with a cooling pack which when shaken can reach low temperature within seconds. The collar is placed around the patient's neck and the cooling pack is applied to the front of the neck and held in place. This device provides stable cooling irrespective of participant size or weight. The objective of this study is to test the value of using Excel Cryo Cooling device in dropping brain temperature in 3 different groups of adult participants:
- Healthy adult volunteers, ii. Adult participants with normal body temperature in intensive care unit iii. Adult participants with fever in intensive care unit
Read the detailed description
To investigate effectiveness, safety and ease of application of Cryo Collar to rapidly reduce core brain temperature, the study will recruit 8 healthy volunteers, 10 adult normothermic participants and 10 adult sick febrile participants from Neurocritical Care ICU in The Ohio State University Wexner Medical Center. Before placing the collar around participant's neck, the investigators will record the participant's ear temperature and heart rate as a baseline. An Excel Cryo Collar will be placed around the participant's neck. After activating the cooling element, the investigators will place it within the neck collar.
The participant's ear temperature will be recorded every 5 minutes. The investigators will replace the cooling element every 20 minutes and continue to record the participant's ear temperature every 5 minutes. A total of 6 cooling elements will be used over 2 hours. The heart rate and blood pressure of the participant will be checked and recorded every 20 minutes when cooling element is replaced. The participant's bedside shivering assessment scale (BSAS) will also be recorded during the study.
Five adult sick febrile participants will receive 2 rounds of cooling procedure each 2 hours long.
The investigators will analyze data gathered from the study in 2 different ways:
First, the investigators will run descriptive statistics in three groups of participant to find out the following variable: Average temperature drop, average time to mild therapeutic hypothermia and change in temperature at the end of study.
Second, the investigators will compare the difference in achieving temperature drop among three groups by comparing mean values of temperature drop in three groups.
- Conditions
- Stroke
- Being tested
- Excel Cryo Cooling Collar
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excel Cryo Cooling CollarDevice
Therapeutic hypothermia in the study will be initiated by The Excel Cryo Cooling system consisting of a unique cervical immobilization collar and a cooling element. Once activated, the cooling element achieves a temperature of -3.0 °C to -5.0 °C within seconds. The collar is fitted around the subject's neck and the cooling element is applied the the front of the neck over the carotid arteries and secured in place by the collar. The Excel System provides consistent cooling regardless of patient size or weight, by cooling of the blood traveling through the carotid triangles.
| Study group | Role | What they receive |
|---|---|---|
| adult healthy volunteer | Experimental | Adult healthy volunteers will be recruited from staff in Dept. Neurology, medical students. They will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours. Receives: Device: Excel Cryo Cooling Collar |
| adult normothermic patient | Experimental | Adult normothermic patients will be recruited from Neurocritical Care ICU in The Ohio State University Wexner Medical Center.
They will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours. Receives: Device: Excel Cryo Cooling Collar |
| adult sick febrile patient | Experimental | Adult sick febrile patients will be enrolled from Neurocritical Care ICU in The Ohio State University Wexner Medical Center.
Five of the patients will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours.
Other five patients will received 2 rounds of cooling process each 2 hours long Receives: Device: Excel Cryo Cooling Collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic hypothermia measured by tympanic temperature
The tympanic temperature in Celsius will be detected in adult healthy volunteers, adult normothermic patients and adult sick febrile patients after receiving one or two rounds of cooling process.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michel Torbey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michel Torbey, Ohio State University
- Investigators
- Michel Torbey, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703675
- Sponsor's protocol ID
- 2015H0207
- Acronym
- CryoCollar
- Status last verified
- Jun 2018
- First submitted
- 15 Jan 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety and Ease of Application of Excel Cryo Cooling Collar to Rapidly Reduce Core Brain Temperature
- ClinicalTrials.gov ID
- NCT02703675
- Acronym / sponsor ID
- CryoCollar / 2015H0207
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Michel TorbeyUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 9 Mar 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.
Research has shown that lowering brain temperature may have good results in heart attack patients. Lowering brain temperature may be a promising treatment for stroke patients. The Excel Cryo Cooling device drops brain temperature by cooling the blood in arteries in the neck. The device is a neck collar with a cooling pack which when shaken can reach low temperature within seconds. The collar is placed around the patient's neck and the cooling pack is applied to the front of the neck and held in place. This device provides stable cooling irrespective of participant size or weight. The objective of this study is to test the value of using Excel Cryo Cooling device in dropping brain temperature in 3 different groups of adult participants:
- Healthy adult volunteers, ii. Adult participants with normal body temperature in intensive care unit iii. Adult participants with fever in intensive care unit
Detailed description
To investigate effectiveness, safety and ease of application of Cryo Collar to rapidly reduce core brain temperature, the study will recruit 8 healthy volunteers, 10 adult normothermic participants and 10 adult sick febrile participants from Neurocritical Care ICU in The Ohio State University Wexner Medical Center. Before placing the collar around participant's neck, the investigators will record the participant's ear temperature and heart rate as a baseline. An Excel Cryo Collar will be placed around the participant's neck. After activating the cooling element, the investigators will place it within the neck collar.
The participant's ear temperature will be recorded every 5 minutes. The investigators will replace the cooling element every 20 minutes and continue to record the participant's ear temperature every 5 minutes. A total of 6 cooling elements will be used over 2 hours. The heart rate and blood pressure of the participant will be checked and recorded every 20 minutes when cooling element is replaced. The participant's bedside shivering assessment scale (BSAS) will also be recorded during the study.
Five adult sick febrile participants will receive 2 rounds of cooling procedure each 2 hours long.
The investigators will analyze data gathered from the study in 2 different ways:
First, the investigators will run descriptive statistics in three groups of participant to find out the following variable: Average temperature drop, average time to mild therapeutic hypothermia and change in temperature at the end of study.
Second, the investigators will compare the difference in achieving temperature drop among three groups by comparing mean values of temperature drop in three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adult healthy volunteer | Experimental | Device: Excel Cryo Cooling CollarAdult healthy volunteers will be recruited from staff in Dept. Neurology, medical students. They will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours. |
| adult normothermic patient | Experimental | Device: Excel Cryo Cooling CollarAdult normothermic patients will be recruited from Neurocritical Care ICU in The Ohio State University Wexner Medical Center. They will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours. |
| adult sick febrile patient | Experimental | Device: Excel Cryo Cooling CollarAdult sick febrile patients will be enrolled from Neurocritical Care ICU in The Ohio State University Wexner Medical Center. Five of the patients will receive a cooling procedure by using the Excel Cryo Cooling Collar around their neck and fitted with activated cooling element for 2 hours. Other five patients will received 2 rounds of cooling process each 2 hours long |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female 18-60 years of age
- Computed Tomography Angiography (CTA) image results show no narrow in carotid artery (not applied to healthy volunteers)
- Be able to accept cooling procedure at least 2 hours
- Provide informed consent.
Key exclusion criteria (8 listed)
- Patients with increased intracerebral pressure (ICP), intracerebral hemorrhage (ICH) and carotid artery stenosis
- Receiving external ventricular drainage
- Taking anti-febrile medications within 4 hours
- Females who are pregnant or breastfeeding
- Subjects who have arrhythmia, other serious cardiac disease, or low blood pressure
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 |
|---|---|---|
| Excel Cryo Cooling CollarTherapeutic hypothermia in the study will be initiated by The Excel Cryo Cooling system consisting of a unique cervical immobilization collar and a cooling element. Once activated, the cooling element achieves a temperature of -3.0 °C to -5.0 °C within seconds. The collar is fitted around the subject's neck and the cooling element is applied the the front of the neck over the carotid arteries and secured in place by the collar. The Excel System provides consistent cooling regardless of patient size or weight, by cooling of the blood traveling through the carotid triangles. | Device | adult healthy volunteer, adult normothermic patient, adult sick febrile patient |
Primary outcome
Therapeutic hypothermia measured by tympanic temperature
Time frame: 6 hours
The tympanic temperature in Celsius will be detected in adult healthy volunteers, adult normothermic patients and adult sick febrile patients after receiving one or two rounds of cooling process.
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 2 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Michel Torbey, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excel Cryo Cooling Collar in people with Stroke, run by Michel Torbey 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 4 inclusion and 8 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 2 Jul 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?
Therapeutic hypothermia measured by tympanic temperature (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2018.