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CRUISE System in Flight
Sponsor: Hernando Gomez
Summary
This is a prospective, observational, blinded clinical study with the purpose of assessing the safety of a non-invasive decision support system for the identification and management of shock (the CRUISE system). Researchers will compare the recommendations provided by the CRUISE system with those executed as part of the standard of care by transport paramedics and medics in acute ill adult critically ill patients in shock or requiring active resuscitation being transported by helicopter (STAT MedEvac) to Presbyterian Hospital. Planned total enrollment is 60 patients.
Official title: CRUISE Blinded STAT Helicopter Study
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-09
Completion Date
2027-09
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
Observation blinded group with the purpose of assessing the safety of a non-invasive decision support system for the identification and management of shock (the CRUISE system).
The sensor device will be removed either by STAT MedEvac personnel or by the investigator after arrival at the hospital. The patient will receive their standard care upon hospital arrival. The sensor device will be manually retrieved by the investigator, and deidentified physiological, and waveform data will be loaded to a research server. Maintain a linkage list to connect this deidentified data back to the original patient. Prehospital XMLs are downloaded from SQL database as XMLs, they are then processed and appended to STATA tables. The primary key (PRID) is then linked to the noninvasive monitors with the same key and temporally matched if key is not present. EHR is linked through secondary keys (MRN and FIN). Further EHR linkage is done by perfectly matching Protected Health Information (PHI) patient name and date of admission from trauma registry. An arbitrary study ID variable is created for each subject, and a linkage list is saved along with all other PHI information