Cardiac ArrestCOOLCAMRINCT02179060
Prehospital Resuscitation Intranasal Cooling Effects Seen in MRI of the Brain After Cardiac Arrest
An observational study of Cardiac Arrest, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Therapeutic hypothermia improves the neurologically-intact survival rates in those patients resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible might be beneficial to those victims. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2014to 1 Apr 2016
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects will be derived from the prehospital cardiac arrest patients from Tampere area treated by the Tampere Area Emergency Medical Service (EMS) led by physician. The study population (N=10) is from Pirkanmaa area. The paramedics are allowed to start intra-arrest cooling by RhinoChill whenever they meet an adult SCA patient in VF/VT. The third group of control subjects are same as used in "Effect of Xenon, in Combination with Therapeutic Hypothermia, on the Brain and on Neurological Outcome following Brain Ischemia in Cardiac Arrest Patients (EudraCT number 2009-009505-25)" -study running in Turku and Helsinki, Finland. They are the prehospital cardiac arrest patients from Turku and Helsinki area treated by the Turku or Helsinki Area Emergency Medical Service.
Who may be able to join
- Ventricular fibrillation or non-perfusive ventricular tachycardia as initial cardiac rhythm.
- The 1st attempt at resuscitation by emergency medical personnel must appear within 15 minutes after the collapse.
- The cause for collapse should be considered primary as cardiogenic and the return of spontaneous circulation (ROSC) should have been gained in 45 minutes after the collapse.
- Patient should be still unconscious in the emergency room.
- Age: 18 - 80 years
- Obtained consent after arrival to the hospital, and before MRI scan.
Who cannot join
- Hypothermia (< 30°C core temperature)
- Arrival of EMS after 15 minutes from collapse
- Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral haemorrhages, intoxications etc.)
- Terminal phase of a chronic disease, or known limitations in therapy and Do Not Resuscitate-order or known pre-arrest Cerebral Performance Category 3 or 4
- Factors making participation in follow-up unlikely
- Factors making the RhinoChill cooling contraindicated: patients with known contraindications to hypothermia (Raynaud's disease, Cryoglobulinemia, Sickle Cell disease), have specific temperature-sensitive pathologies (e.g., serum cold agglutinins, Buerger's disease), intranasal obstruction, or known skull base fracture.
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- Pregnancy
- Coagulopathy
- Response to verbal commands after the return of spontaneous circulation (ROSC)
- Systolic arterial pressure < 80 mmHg or mean arterial pressure < 60 mmHg for over 30 min period after ROSC
- Evidence of hypoxemia (arterial oxygen saturation < 85%) for > 15 minutes after ROSC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehospital Resuscitation Intranasal Cooling Effects Seen in Magnetic Resonance Imaging of the Brain After Cardiac Arrest
Therapeutic hypothermia improves the neurologically-intact survival rates in those patients resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible might be beneficial to those victims. Diffusion Tensor Imaging and diffusion-weighted magnetic resonance imaging have recently shown to be able to identify early ischemia-related changes within the brain three days after cardiac arrest, among sudden cardiac arrest patients cooled in hospital. The physical changes seen within the brain may be able to distinguish survivors at very early phase.
This study aims to assess early ischemia-related changes of the brain seen in MRI approximately three days after cardiac arrest. The hypotheses is that MRI will differ in the groups of patients treated with early intra-arrest cooling with the RhinoChill device and in hospital hypothermia in 36 Celsius, in the group of patients treated with normal in hospital hypothermia in 36 Celsius only, in the group of patients treated with normal in hospital hypothermia in 33 Celsius only (The historical Xenon study patients). The primary endpoint is the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI, and secondary endpoints are total survival at 90 days, and time to reach a target temperature (≤36/33 Celsius).
Read the detailed description
Medical personnel (e.g,. nurses or physicians) responding to a cardiac arrest will assess each patient for study inclusion. During resuscitation patients will receive standard ALS (advanced life support) according to European Resuscitation Council (ERC) guidelines with cooling with the RhinoChill upon determining that the patient is in cardiac arrest. The RhinoChill catheters should be placed and cooling initiated immediately after airway management (i.e. laryngeal mask or intubation). The aim is that cooling should be started within 15 minutes from the call to the dispatch centre. Specifically, cooling with chilled saline or cold packs in the field or ambulance will not be permitted. Resuscitation attempts should be continued for at least 45 minutes after the collapse in all patients having venticular fibrillation (VF) or non-perfusive venticular tachycardia (VT) as initial cardiac rhythm before deciding that further interventions are futile.
Automated external defibrillator (AEDs) with the capability to record data will be used in each resuscitation attempt, and the quality of cardio pulmonary resuscitation (CPR) is followed.
RhinoChill cooling will be continued in those subjects that achieve ROSC and remain comatose. Bolus doses of sedation and analgesia will be administered for their transport to the hospital according to local protocol. RhinoChill cooling will be continued at the hospital until the subject can be successfully transitioned to the standard institutional cooling protocol.
Clinical assessments and clinically relevant adverse events will be documented from the time the patient is enrolled to the study until the first of the following two events occur: death or MRI scan.
Patients that regain consciousness following ROSC and prior to hospital transport will be excluded. Patient's still unconscious in the emergency room are admitted to ICU and therapeutic cooling is continued for 24 to 36 hours. The MRI scan will take place within 16 hours after rewarming. After that the sedation is stopped and patient extubated if possible. The study is finished at that point and normal patient care continues.
The study continues until 10 patients with MRI scan are enrolled in Tampere University Hospital (TAUH).
- Conditions
- Cardiac Arrest
- Keywords
- Sudden cardiac arrest, RhinoChill -cooling, MRI
- Medical subject headings
- Heart Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cooling group | The RhinoChill® cooling is started as soon as possible to the patients with Cardiac arrest, and before the return of spontaneous circulation | |
| Control group | Standard care, no cooling during pre-hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI
Measured: 36-49 hours after cardiac arrest
Secondary outcomes (1)
the total survival at 90 days
Measured: 90 days after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJun 2014
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
Why it stopped: Lack of study funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Helsinki University Central Hospital, BeneChill, Inc
- Responsible party
- Sponsor
- Investigators
- Sanna Hoppu, MD, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179060
- Sponsor's protocol ID
- R14025
- Acronym
- COOLCAMRI
- Status last verified
- Mar 2018
- First submitted
- 2 Jun 2014
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Resuscitation Intranasal Cooling Effects Seen in Magnetic Resonance Imaging of the Brain After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02179060
- Acronym / sponsor ID
- COOLCAMRI / R14025
- Conditions
- Cardiac Arrest
- Keywords
- Sudden cardiac arrest, RhinoChill -cooling, MRI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of study funding
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Helsinki University Central Hospital, BeneChill, Inc
- Study start
- Jun 2014
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 1 Jul 2014 (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.
Therapeutic hypothermia improves the neurologically-intact survival rates in those patients resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible might be beneficial to those victims. Diffusion Tensor Imaging and diffusion-weighted magnetic resonance imaging have recently shown to be able to identify early ischemia-related changes within the brain three days after cardiac arrest, among sudden cardiac arrest patients cooled in hospital. The physical changes seen within the brain may be able to distinguish survivors at very early phase.
This study aims to assess early ischemia-related changes of the brain seen in MRI approximately three days after cardiac arrest. The hypotheses is that MRI will differ in the groups of patients treated with early intra-arrest cooling with the RhinoChill device and in hospital hypothermia in 36 Celsius, in the group of patients treated with normal in hospital hypothermia in 36 Celsius only, in the group of patients treated with normal in hospital hypothermia in 33 Celsius only (The historical Xenon study patients). The primary endpoint is the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI, and secondary endpoints are total survival at 90 days, and time to reach a target temperature (≤36/33 Celsius).
Detailed description
Medical personnel (e.g,. nurses or physicians) responding to a cardiac arrest will assess each patient for study inclusion. During resuscitation patients will receive standard ALS (advanced life support) according to European Resuscitation Council (ERC) guidelines with cooling with the RhinoChill upon determining that the patient is in cardiac arrest. The RhinoChill catheters should be placed and cooling initiated immediately after airway management (i.e. laryngeal mask or intubation). The aim is that cooling should be started within 15 minutes from the call to the dispatch centre. Specifically, cooling with chilled saline or cold packs in the field or ambulance will not be permitted. Resuscitation attempts should be continued for at least 45 minutes after the collapse in all patients having venticular fibrillation (VF) or non-perfusive venticular tachycardia (VT) as initial cardiac rhythm before deciding that further interventions are futile.
Automated external defibrillator (AEDs) with the capability to record data will be used in each resuscitation attempt, and the quality of cardio pulmonary resuscitation (CPR) is followed.
RhinoChill cooling will be continued in those subjects that achieve ROSC and remain comatose. Bolus doses of sedation and analgesia will be administered for their transport to the hospital according to local protocol. RhinoChill cooling will be continued at the hospital until the subject can be successfully transitioned to the standard institutional cooling protocol.
Clinical assessments and clinically relevant adverse events will be documented from the time the patient is enrolled to the study until the first of the following two events occur: death or MRI scan.
Patients that regain consciousness following ROSC and prior to hospital transport will be excluded. Patient's still unconscious in the emergency room are admitted to ICU and therapeutic cooling is continued for 24 to 36 hours. The MRI scan will take place within 16 hours after rewarming. After that the sedation is stopped and patient extubated if possible. The study is finished at that point and normal patient care continues.
The study continues until 10 patients with MRI scan are enrolled in Tampere University Hospital (TAUH).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling group | – | –The RhinoChill® cooling is started as soon as possible to the patients with Cardiac arrest, and before the return of spontaneous circulation |
| Control group | – | –Standard care, no cooling during pre-hospital care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects will be derived from the prehospital cardiac arrest patients from Tampere area treated by the Tampere Area Emergency Medical Service (EMS) led by physician. The study population (N=10) is from Pirkanmaa area. The paramedics are allowed to start intra-arrest cooling by RhinoChill whenever they meet an adult SCA patient in VF/VT. The third group of control subjects are same as used in "Effect of Xenon, in Combination with Therapeutic Hypothermia, on the Brain and on Neurological Outcome following Brain Ischemia in Cardiac Arrest Patients (EudraCT number 2009-009505-25)" -study running in Turku and Helsinki, Finland. They are the prehospital cardiac arrest patients from Turku and Helsinki area treated by the Turku or Helsinki Area Emergency Medical Service.
Key inclusion criteria (6 listed)
- Ventricular fibrillation or non-perfusive ventricular tachycardia as initial cardiac rhythm.
- The 1st attempt at resuscitation by emergency medical personnel must appear within 15 minutes after the collapse.
- The cause for collapse should be considered primary as cardiogenic and the return of spontaneous circulation (ROSC) should have been gained in 45 minutes after the collapse.
- Patient should be still unconscious in the emergency room.
- Age: 18 - 80 years
Key exclusion criteria (11 listed)
- Hypothermia (< 30°C core temperature)
- Arrival of EMS after 15 minutes from collapse
- Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral haemorrhages, intoxications etc.)
- Terminal phase of a chronic disease, or known limitations in therapy and Do Not Resuscitate-order or known pre-arrest Cerebral Performance Category 3 or 4
- Factors making participation in follow-up unlikely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI
Time frame: 36-49 hours after cardiac arrest
1 secondary outcome
the total survival at 90 days
Time frame: 90 days after cardiac arrest
Results and safety
The study was stopped early (reason given: Lack of study funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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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.
Sanna Hoppu, MD, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Tampere University Hospital at 1 site in Finland.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Mar 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 Finland. 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 was stopped early (reason given: Lack of study funding). Results are not available in the source record.
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?
the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI (time frame: 36-49 hours after cardiac arrest). 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 21 Mar 2018.