CRUISE System in Flight

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.

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Key information

Conditions

Shock Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All adult patients with signs of shock evaluated, treated, and/or transported by Emergency Medical Services under medical oversight of UPMC EMS Medical Directors and/or arriving at UPMC facilities with which the PI and Co-investigators routinely have access to the records.

Exclusion criteria

Age < 18 years
Active atrial fibrillation or irregular rhythm
Open chest
Known right ventricular failure

Treatment and study plan

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).

Device

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

Primary outcomes

CRUISE system decisions Versus Standard Care by Transport decisions - total time to resuscitate

Time frame: Up to 4 hours of monitoring

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hernando Gomez, MD

CONTACT

[email protected]

Howard R Stein, MS

CONTACT

[email protected]

412-874-9992

Sponsors and collaborators

Lead sponsor

Hernando Gomez

Other

Collaborators

United States Department of Defense

Registry information

Official study title

CRUISE Blinded STAT Helicopter Study

Acronym: CRUISE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 9, 2026
Registry last updated: Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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Completed