CRUISE System in Flight

NCT07637240 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: STUDY25080077HT942524C0121
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Helicopter; Shock; Transport; Resuscitation; Trauma; Medical; Device; STAT Medvec; Emergency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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).

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). 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

Observational Blinded Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hernando Gomez: lead
• United States Department of Defense: collaborator

Related Publications (9)

• Food and Drug Administration. "Guidance for industry: oversight of clinical investigations-a risk-based approach to monitoring." Silver Spring, MD: FDA (2013).

  BACKGROUND

• 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.

  PMID: 28188408 BACKGROUND

• 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.

  PMID: 10433528 BACKGROUND

• 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.

  PMID: 10622382 BACKGROUND

• 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.

  PMID: 17171947 BACKGROUND

• 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.

  PMID: 10051276 BACKGROUND

• 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.

  PMID: 10903232 BACKGROUND

• 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.

  PMID: 10794325 BACKGROUND

• 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.

  PMID: 8782638 BACKGROUND

MeSH Terms

Conditions

Shock; Wounds and Injuries; Emergencies

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Hernando Gomez, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Howard R Stein, MS

CONTACT

412-874-9992; hos12@pitt.edu

Hernando Gomez, MD

CONTACT

gomezh@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share