Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

NCT00410969 | Completed Phase 1 DMC

• 1 other identifier: LRS-01-05-02
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Arrest; Coma

Keywords

resuscitation; hypothermia

Outcome Measures

Primary Outcomes (7)

• Time from collapse to achieving desired range of cooling (32.0 to 34.0°C)

  Day of treatment

• Time from deployment of the ThermoSuit™ (start of cooled water flow to patient) to core temperature < 34.0°C

  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.

  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.

  First day after treatment

• Ease of use of the TSS (evaluated by clinical staff using the Product Performance Assessment questionnaire, Appendix 7)

  Day of treatment

• Duration of maintenance of hypothermia without supplemental cooling

  First day after treatment

• Ease of maintenance of hypothermia for 24 hours (whether or not supplemental cooling is needed)

  First day after treatment

Secondary Outcomes (8)

• Total number of days in ICU

  Time that patient is in ICU

• Barriers to compliance

  First day after treatment

• Neurologic and physical status during in-hospital recovery

  Time that patient is in hospital

• Neurologic and physical status at discharge

  Time that patient is discharged from hospital

• Neurologic and physical status at 30 ± 7 days follow-up for surviving patients

  30 ± 7 days after hospital discharge

Interventions

ThermoSuit(R) System DEVICE

The LRS ThermoSuit System is used to cool patients using direct contact of the skin with cold water.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[GCS ≤ 8\].

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Life Recovery Systems: lead
• Unity Health Toronto: collaborator
• Kingston Health Sciences Centre: collaborator

Study Sites (2)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Links

• Website for Life Recovery Systems

MeSH Terms

Conditions

Heart Arrest; Coma; Hypothermia

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Dorian Paul, MD

  St. Michael's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

• Daniel Howes, M.D.

  Kingston Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Start: December 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 29, 2008

Record last verified: 2008-09

Locations

CA (2)