CRUISE System in Flight (CRUISE)
5. august 2026 oppdatert av: Hernando Gomez
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
60
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Howard R Stein, MS
- Telefonnummer: 412-874-9992
- E-post: hos12@pitt.edu
Studer Kontakt Backup
- Navn: Hernando Gomez, MD
- E-post: gomezh@upmc.edu
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Critical ill patients being transported to the hospital by EMS to the core tertiary UPMC hospitals (UPMC Presbyterian, Shadyside, Mercy, and Passavant).
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Observational Blinded Group
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
CRUISE system decisions Versus Standard Care by Transport decisions - total time to resuscitate
Tidsramme: 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 |
Up to 4 hours of monitoring
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hernando Gomez, MD, University of Pittsburgh
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. september 2027
Datoer for studieregistrering
Først innsendt
3. april 2026
Først innsendt som oppfylte QC-kriteriene
5. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY25080077
- HT942524C0121 (Annet stipend/finansieringsnummer: Combat Casualty Care Research Program (CCCRP))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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