UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15216, United States
NCT Number: NCT03889340
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.
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Notify Me18 year and older
All sexes
Observational
Pittsburgh, Pennsylvania, 15216, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will undergo hypothermia therapy with the IQool system
Time frame: Up to 12 hours
Induction of hypothermia will occur at a rate of at least 1C/hr
Time frame: 24 hours
The IQool system will maintain temperature within 0.5C of goal temperature for 75% of the maintenance phase
Time frame: Up to16 hours
When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming
Time frame: 72 hours
Clinicians will be asked if they agree that the IQool system provides effective temperature management >90% of the time
Adam Frisch
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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