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

NCT00384319 | Completed Phase 1

• 1 other identifier: LRS-01-06-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Cardiac Arrest; Comatose

Keywords

resuscitation; hypothermia

Outcome Measures

Primary Outcomes (7)

• Primary: 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 12 hours (whether or not supplemental cooling is needed)

  First 12 hours after treatment

Secondary Outcomes (6)

• Secondary: Total number of days in ICU;

  Time while patient is in ICU

• Barriers to compliance;

  First day after treatment

• Neurologic and physical status during in-hospital recovery;

  Time while patient is hospitalized

• Neurologic and physical status at discharge;

  Time at which patient is discharged for 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 ThermoSuit device 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).
• 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 \[GCS ≤ 8\].

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 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).
• 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).

Sponsors & Collaborators

• Life Recovery Systems: lead
• Medical University of Vienna: collaborator

Study Sites (1)

General Hospital, University of Vienna

Vienna, A-1090, Austria

Location

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

• Michael Holzer, MD

  General Hospital, University of Vienna

  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: October 4, 2006
• First Posted: October 6, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 4, 2008

Record last verified: 2007-12

Locations

AU (1)