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CRUISE System in Flight

NCT07637240 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Shock

Interventions

DEVICE

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Hernando Gomez

    lead OTHER

Principal Investigators

  • Hernando Gomez, MD · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-07-31
Completion
2027-09-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07637240 on ClinicalTrials.gov