Heart ArrestPhase 1NCT00410969
Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients
A Phase 1 study testing ThermoSuit(R) System in people with Heart Arrest and Coma, run by Life Recovery Systems at 2 sites in Canada.
Trial summary
The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Coma
- What is being tested?
- ThermoSuit(R) System
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2006to Sep 2008
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
- Cardiac arrest of presumed cardiac origin.
- Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole.
- Estimated or known age > 18 years.
- Intubation, ventilation and placement of esophageal probe.
- Estimated time from collapse to the initiation of Advanced Cardiac Life Support (ACLS) < 15 minutes and return of spontaneous circulation with defibrillation within 60 minutes of collapse.
- Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS ≤ 8].
Who cannot join
- Height greater than 188 cm.
- Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
- Core temperature less than 34°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space, nasopharynx, or central blood vessel).
- Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
- Known pregnancy.
- Response to verbal commands after ROSC (but before enrollment).
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- Known terminal illness that preceded the arrest.
- Known enrollment in another study of a device, drug, or biologic.
- Major trauma or other co-morbidity requiring urgent surgery.
- Improving neurologic status.
- > 8 hours since return of spontaneous circulation.
- Unknown time of arrest.
- Severe or known coagulopathy (with active bleeding).
- Hemodynamic instability despite vasopressors (SBP < 90 mmHg or MAP < 60 mmHg for > 30 minutes after ROSC and before enrollment).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.
Read the detailed description
The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.
- Conditions
- Heart Arrest, Coma
- Being tested
- ThermoSuit(R) System
- Keywords
- resuscitation, hypothermia
- Medical subject headings
- Heart Arrest, Coma, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoSuit(R) SystemDevice
The LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from collapse to achieving desired range of cooling (32.0 to 34.0°C)
Measured: Day of treatment
Time from deployment of the ThermoSuit™ (start of cooled water flow to patient) to core temperature < 34.0°C
Measured: Day of treatment
Total time during the first 24 hours after cooling is initiated that the core temperature is between 32.0 and 34.0°C.
Measured: First day after treatment
Protocol compliance: This is defined as the proportion of patients in whom compliance (i.e. target temperature range) is achieved 85% of the time.
Measured: First day after treatment
Ease of use of the TSS (evaluated by clinical staff using the Product Performance Assessment questionnaire, Appendix 7)
Measured: Day of treatment
Duration of maintenance of hypothermia without supplemental cooling
Measured: First day after treatment
Ease of maintenance of hypothermia for 24 hours (whether or not supplemental cooling is needed)
Measured: First day after treatment
Secondary outcomes (8)
Total number of days in ICU
Measured: Time that patient is in ICU
Barriers to compliance
Measured: First day after treatment
Neurologic and physical status during in-hospital recovery
Measured: Time that patient is in hospital
Neurologic and physical status at discharge
Measured: Time that patient is discharged from hospital
Neurologic and physical status at 30 ± 7 days follow-up for surviving patients
Measured: 30 ± 7 days after hospital discharge
Incidence of shivering during cooling and maintenance of hypothermia
Measured: First day after treatment
Requirements for use of paralysis to control shivering
Measured: First day after treatment
Neurologic and physical status at 6 month ± 15 days follow-up.
Measured: 6 months ± 15 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life Recovery Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Kingston Health Sciences Centre
- Investigators
- Dorian Paul, MD, Principal investigator, St. Michael's Hospital, University of TorontoDaniel Howes, M.D., Principal investigator, Kingston Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410969
- Sponsor's protocol ID
- LRS-01-05-02
- Status last verified
- Sep 2008
- First submitted
- 12 Dec 2006
- Last updated
- 29 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients
- ClinicalTrials.gov ID
- NCT00410969
- Acronym / sponsor ID
- LRS-01-05-02
- Conditions
- Heart Arrest, Coma
- Keywords
- resuscitation, hypothermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Life Recovery SystemsUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Kingston Health Sciences Centre
- Study start
- Dec 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Dec 2006 (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.
The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.
Detailed description
The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
- Cardiac arrest of presumed cardiac origin.
- Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole.
- Estimated or known age > 18 years.
- Intubation, ventilation and placement of esophageal probe.
Key exclusion criteria (14 listed)
- Height greater than 188 cm.
- Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
- Core temperature less than 34°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space, nasopharynx, or central blood vessel).
- Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
- Known pregnancy.
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 |
|---|---|---|
| ThermoSuit(R) SystemThe LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water. | Device | – |
Primary outcome
Time from collapse to achieving desired range of cooling (32.0 to 34.0°C)
Time frame: Day of treatment
Time from deployment of the ThermoSuit™ (start of cooled water flow to patient) to core temperature < 34.0°C
Time frame: Day of treatment
Total time during the first 24 hours after cooling is initiated that the core temperature is between 32.0 and 34.0°C.
Time frame: First day after treatment
Protocol compliance: This is defined as the proportion of patients in whom compliance (i.e. target temperature range) is achieved 85% of the time.
Time frame: First day after treatment
Ease of use of the TSS (evaluated by clinical staff using the Product Performance Assessment questionnaire, Appendix 7)
Time frame: Day of treatment
Duration of maintenance of hypothermia without supplemental cooling
Time frame: First day after treatment
Ease of maintenance of hypothermia for 24 hours (whether or not supplemental cooling is needed)
Time frame: First day after treatment
8 secondary outcomes
Total number of days in ICU
Time frame: Time that patient is in ICU
Barriers to compliance
Time frame: First day after treatment
Neurologic and physical status during in-hospital recovery
Time frame: Time that patient is in hospital
Neurologic and physical status at discharge
Time frame: Time that patient is discharged from hospital
Neurologic and physical status at 30 ± 7 days follow-up for surviving patients
Time frame: 30 ± 7 days after hospital discharge
Incidence of shivering during cooling and maintenance of hypothermia
Time frame: First day after treatment
Requirements for use of paralysis to control shivering
Time frame: First day after treatment
Neurologic and physical status at 6 month ± 15 days follow-up.
Time frame: 6 months ± 15 days after hospital discharge
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 29 Sep 2008.
- Website for Life Recovery SystemsLink provided by the sponsor.
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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.
Dorian Paul, MD principal investigator
St. Michael's Hospital, University of Toronto
Daniel Howes, M.D. principal investigator
Kingston Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ThermoSuit(R) System in people with Heart Arrest and Coma, run by Life Recovery Systems at 2 sites in Canada.
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 7 inclusion and 14 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 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time from collapse to achieving desired range of cooling (32.0 to 34.0°C) (time frame: Day of treatment). The study lists 7 primary outcomes in all. 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 29 Sep 2008.