CRUISE System in Flight (CRUISE)

CRUISE Blinded STAT Helicopter Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shock
• Intervention / Treatment: 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).

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Howard R Stein, MS; Phone Number: 412-874-9992; Email: hos12@pitt.edu
• Study Contact Backup: Name: Hernando Gomez, MD; Email: gomezh@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critical ill patients being transported to the hospital by EMS to the core tertiary UPMC hospitals (UPMC Presbyterian, Shadyside, Mercy, and Passavant).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational Blinded Group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 4 hours of monitoring

Collaborators and Investigators

• Sponsor: Hernando Gomez
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Hernando Gomez, MD, University of Pittsburgh

Publications and helpful links

General Publications

• Michard F, Boussat S, Chemla D, Anguel N, Mercat A, Lecarpentier Y, Richard C, Pinsky MR, Teboul JL. Relation between respiratory changes in arterial pulse pressure and fluid responsiveness in septic patients with acute circulatory failure. Am J Respir Crit Care Med. 2000 Jul;162(1):134-8. doi: 10.1164/ajrccm.162.1.9903035.
• Michard F, Chemla D, Richard C, Wysocki M, Pinsky MR, Lecarpentier Y, Teboul JL. Clinical use of respiratory changes in arterial pulse pressure to monitor the hemodynamic effects of PEEP. Am J Respir Crit Care Med. 1999 Mar;159(3):935-9. doi: 10.1164/ajrccm.159.3.9805077.
• Lamia B, Kim HK, Severyn DA, Pinsky MR. Cross-comparisons of trending accuracies of continuous cardiac-output measurements: pulse contour analysis, bioreactance, and pulmonary-artery catheter. J Clin Monit Comput. 2018 Feb;32(1):33-43. doi: 10.1007/s10877-017-9983-4. Epub 2017 Feb 10.
• Ramsey SD, Saint S, Sullivan SD, Dey L, Kelley K, Bowdle A. Clinical and economic effects of pulmonary artery catheterization in nonemergent coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2000 Apr;14(2):113-8. doi: 10.1016/s1053-0770(00)90001-6.
• Food and Drug Administration. "Guidance for industry: oversight of clinical investigations-a risk-based approach to monitoring." Silver Spring, MD: FDA (2013).
• Summers RL, Kolb JC, Woodward LH, Galli RL. Differentiating systolic from diastolic heart failure using impedance cardiography. Acad Emerg Med. 1999 Jul;6(7):693-9. doi: 10.1111/j.1553-2712.1999.tb00437.x.
• Summers RL, Kolb JC, Woodward LH, Galli RL. Diagnostic uses for thoracic electrical bioimpedance in the emergency department: clinical case series. Eur J Emerg Med. 1999 Sep;6(3):193-9. doi: 10.1097/00063110-199909000-00004.
• Siegel LC, Shafer SL, Martinez GM, Ream AK, Scott JC. Simultaneous measurements of cardiac output by thermodilution, esophageal Doppler, and electrical impedance in anesthetized patients. J Cardiothorac Anesth. 1988 Oct;2(5):590-5. doi: 10.1016/0888-6296(88)90049-x.
• Connors AF Jr, Speroff T, Dawson NV, Thomas C, Harrell FE Jr, Wagner D, Desbiens N, Goldman L, Wu AW, Califf RM, Fulkerson WJ Jr, Vidaillet H, Broste S, Bellamy P, Lynn J, Knaus WA. The effectiveness of right heart catheterization in the initial care of critically ill patients. SUPPORT Investigators. JAMA. 1996 Sep 18;276(11):889-97. doi: 10.1001/jama.276.11.889.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Shock; Device; Emergency; Medical; Trauma; Resuscitation; Transport; Helicopter; STAT Medvec
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Wounds and Injuries; Shock
• Other Study ID Numbers: STUDY25080077; HT942524C0121 (Other Grant/Funding Number: Combat Casualty Care Research Program (CCCRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No