An observational study in Shock, sponsored by Hernando Gomez. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Hernando Gomez · Observational
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.
The objective is to compare the performance of the CRUISE system compared to the actions executed by the critical care transport teams during the resuscitation of patients with shock or in need of active resuscitation while being transported from the field or outside hospitals to all core hospitals in the UPMC system (Presbyterian, Shadyside, Mercy and Passavant Hospitals). Specifically, focus on safety, which will define in several domains including (i) a comparison of the recommendations of the CRUISE system and the actions executed by the transport team, (ii) the differences in dose of blood, crystalloids and vasopressors between the two, (iii) the presence of artifacts in the monitoring systems leading to false positives or false negatives with both the CRUISE system and medical team, and (iv) the difference in time to intervention between the medic team and CRUISE recommendations. Researchers hypothesize that the recommendations provided by the CRUISE system will lead to faster interventions, with less fluid and lower levels of norepinephrine than the resuscitation driven by the transport teams.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 247 observational studies indexed under Shock.
Browse Shock studies →Hernando Gomez is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critical ill patients being transported to the hospital by EMS to the core tertiary UPMC hospitals (UPMC Presbyterian, Shadyside, Mercy, and Passavant).
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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
CRUISE system decisions Versus Standard Care by Transport decisions - total time to resuscitate
Measurable Outcome Description: 1.Overall comparison between CRUISE GEN system \& Standard Care by Transport paramedics in amount of time spent on resuscitating acute ill adult critically ill patients in shock. Name of Measurement: Total Length of time to resuscitate Measurement Tool: CRUISE Device clock data collected Versus Standard Care Device Clock data collected
Time frame: Up to 4 hours of monitoring
No study locations are listed for this record.
Plan to share: No — The plan is not to share any data outside the study team. The DOD requires all vendors to sign NDAs and commit to the rules of the study. Any party that may have access to the data will be part of the study team and committed thru NDAs \& subcontracts.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hernando Gomez