ShockCRUISENCT07637240
CRUISE System in Flight
An observational study of Shock, run by Hernando Gomez.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shock
- What is being tested?
- 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).
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical ill patients being transported to the hospital by EMS to the core tertiary UPMC hospitals (UPMC Presbyterian, Shadyside, Mercy, and Passavant).
Who may be able to join
- 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.
Who cannot join
- Age < 18 years
- Active atrial fibrillation or irregular rhythm
- Open chest
- Known right ventricular failure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hernando Gomez, MD contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Shock
- Being tested
- 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).
- Keywords
- Helicopter, Shock, Transport, Resuscitation, Trauma, Medical, Device, STAT Medvec, Emergency
- Medical subject headings
- Shock, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Observational Blinded Group | Not described Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 4 hours of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hernando Gomez
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Hernando Gomez, University of Pittsburgh
- Investigators
- Hernando Gomez, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637240
- Sponsor's protocol ID
- STUDY25080077
- Other IDs
- HT942524C0121
- Acronym
- CRUISE
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
Food and Drug Administration. "Guidance for industry: oversight of clinical investigations-a risk-based approach to monitoring." Silver Spring, MD: FDA (2013).
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.
PubMed 28188408Summers 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.
PubMed 10433528Summers 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.
PubMed 10622382Siegel 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.
PubMed 17171947Michard 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.
PubMed 10051276Michard 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.
PubMed 10903232Ramsey 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.
PubMed 10794325Connors 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.
PubMed 8782638
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRUISE Blinded STAT Helicopter Study
- ClinicalTrials.gov ID
- NCT07637240
- Acronym / sponsor ID
- CRUISE / STUDY25080077
- Conditions
- Shock
- Keywords
- Helicopter, Shock, Transport, Resuscitation, Trauma, Medical, Device, STAT Medvec
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hernando GomezUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical ill patients being transported to the hospital by EMS to the core tertiary UPMC hospitals (UPMC Presbyterian, Shadyside, Mercy, and Passavant).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Age < 18 years
- Active atrial fibrillation or irregular rhythm
- Open chest
- Known right ventricular failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Observational Blinded Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- BackgroundFood and Drug Administration. "Guidance for industry: oversight of clinical investigations-a risk-based approach to monitoring." Silver Spring, MD: FDA (2013).
- Background: PubMed 28188408Lamia 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.
- Background: PubMed 10433528Summers 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.
- Background: PubMed 10622382Summers 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.
- Background: PubMed 17171947Siegel 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.
- Background: PubMed 10051276Michard 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.
- Background: PubMed 10903232Michard 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.
- Background: PubMed 10794325Ramsey 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.
- Background: PubMed 8782638Connors 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hernando Gomez, MD contact
Hernando Gomez, MD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Hernando Gomez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Howard R Stein, MS (412-874-9992, hos12@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRUISE system decisions Versus Standard Care by Transport decisions - total time to resuscitate (time frame: Up to 4 hours of monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07637240, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.