Cardiac Arrest With Successful Resuscitation
Conditions
Keywords
resuscitation, cardiac arrest, coma
Brief summary
This submission is a pilot in which the new IQool Warming System device will be used to maintain the temperature of adult patients in cardiac arrest within a range of within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQool Warming System has received a 510 K Clearance by the FDA.
Detailed description
Subjects will receive temperature management using the IQool. This is an FDA approved device. Managing temperature is part of standard care for this population and surface cooling is commonly employed. The following phases will be conducted as standard of care, and will be reviewed for this study: Induction phase: When a subject is included in the study, the IQool will be connected to the patient and activated. The induction period will continue until the patient has reached the upper limit of the target temperature range (defined as 0.5°C above the target temperature). Maintenance phase: Set target temperature will be maintained for 24 hours. The maintenance phase begins when the subject temperature is within 0.5°C of goal temperature. The maintenance phase is completed 24 hours after first reaching below the upper limit of the target temperature range. Rewarming phase: After 24 hours of maintenance, gradual rewarming at 0.25 °C/h will commence. When the subject reaches 37°C the TTM period is completed and the IQool will continue to provide fever control. Post TTM fever control: The subject will be kept at a body temperature of 37°C until 72 hours after the cardiac arrest or earlier if the subject regains consciousness.
Interventions
DEVICEIQool
Subjects will undergo hypothermia therapy with the IQool system
Sponsors
BrainCool
Adam Frisch
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* In- or out-of-hospital cardiac arrest of all initial rhythms * Adult patients (18 years of age and older) * Unconscious on admission to hospital, defined as not following commands * Indication for targeted temperature management
Exclusion criteria
* Pregnancy * Prisoner * Active do not resuscitate order * Any patient not expected to survive 72 hours * Skin infection * Skin wound affecting site of temperature exchange pads
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hypothermia induction | Up to 12 hours | Induction of hypothermia will occur at a rate of at least 1C/hr |
| Maintenance of hypothermia | 24 hours | The IQool system will maintain temperature within 0.5C of goal temperature for 75% of the maintenance phase |
| Rewarming rate | Up to16 hours | When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of physicians that recommend the IQool system for temperature management | 72 hours | Clinicians will be asked if they agree that the IQool system provides effective temperature management \>90% of the time |
Countries
United States
Outcome results
None listed