CRUISE System in Flight
ConditionShock
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorHernando Gomez
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age < 18 years
Active atrial fibrillation or irregular rhythm
Open chest
Known right ventricular failure
Trial population
Critical ill patients being transported to the hospital by EMS to the core tertiary UPMC hospitals (UPMC Presbyterian, Shadyside, Mercy, and Passavant).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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).
DeviceThe 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
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Observational Blinded Group1 intervention
Trial outcomes
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
Time frame
Up to 4 hours of monitoringLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hernando Gomez
Lead sponsor
University of Pittsburgh
Sponsor institution
United States Department of Defense
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: