Cardiac ArrestPhase 1NCT00384319
Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients
A Phase 1 study testing ThermoSuit(R) System in people with Cardiac Arrest and Comatose, run by Life Recovery Systems at 1 site in Austria.
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
- Cardiac Arrest, Comatose
- What is being tested?
- ThermoSuit(R) System
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2006to Dec 2007
- 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).
- 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.
- 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 35°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.
- > 4 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
1 site in 1 country.
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
- Cardiac Arrest, Comatose
- 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 ThermoSuit device 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.
Primary: 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 12 hours (whether or not supplemental cooling is needed)
Measured: First 12 hours after treatment
Secondary outcomes (6)
Secondary: Total number of days in ICU;
Measured: Time while patient is in ICU
Barriers to compliance;
Measured: First day after treatment
Neurologic and physical status during in-hospital recovery;
Measured: Time while patient is hospitalized
Neurologic and physical status at discharge;
Measured: Time at which patient is discharged for hospital
Neurologic and physical status at 30 ± 7 days follow-up for surviving patients;
Measured: 30 ± 7 days after hospital discharge
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 posted6 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionDec 2007
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.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life Recovery Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Investigators
- Michael Holzer, MD, Principal investigator, General Hospital, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384319
- Sponsor's protocol ID
- LRS-01-06-01
- Status last verified
- Dec 2007
- First submitted
- 4 Oct 2006
- Last updated
- 4 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 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
- NCT00384319
- Acronym / sponsor ID
- LRS-01-06-01
- Conditions
- Cardiac Arrest, Comatose
- Keywords
- resuscitation, hypothermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Life Recovery SystemsUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Oct 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 (5 listed)
- Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
- 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.
- Persistent neurologic dysfunction i.e. comatose upon enrollment [GCS ≤ 8].
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 35°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 ThermoSuit device is used to cool patients using direct contact of the skin with cold water. | Device | – |
Primary outcome
Primary: 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 12 hours (whether or not supplemental cooling is needed)
Time frame: First 12 hours after treatment
6 secondary outcomes
Secondary: Total number of days in ICU;
Time frame: Time while patient is in ICU
Barriers to compliance;
Time frame: First day after treatment
Neurologic and physical status during in-hospital recovery;
Time frame: Time while patient is hospitalized
Neurologic and physical status at discharge;
Time frame: Time at which patient is discharged for hospital
Neurologic and physical status at 30 ± 7 days follow-up for surviving patients;
Time frame: 30 ± 7 days after hospital discharge
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 4 Jan 2008.
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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.
Michael Holzer, MD principal investigator
General Hospital, University of Vienna
1 site 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 Cardiac Arrest and Comatose, run by Life Recovery Systems at 1 site in Austria.
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 5 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 4 Jan 2008. 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 Austria. 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?
Primary: 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 4 Jan 2008.