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| ID | Type | Description | Link |
|---|---|---|---|
| HT942524C0121 | Other Grant/Funding Number | Combat Casualty Care Research Program (CCCRP) |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Blinded Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male Female
Critical ill patients being transported to the hospital by EMS to the core tertiary UPMC hospitals (UPMC Presbyterian, Shadyside, Mercy, and Passavant).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Howard R Stein, MS | Contact | 412-874-9992 | hos12@pitt.edu | |
| Hernando Gomez, MD | Contact | gomezh@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hernando Gomez, MD | University of Pittsburgh | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Food and Drug Administration. "Guidance for industry: oversight of clinical investigations-a risk-based approach to monitoring." Silver Spring, MD: FDA (2013). | ||
| 28188408 | 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. | |
| 10433528 |
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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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| ID | Term |
|---|---|
| D012769 | Shock |
| D014947 | Wounds and Injuries |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| 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. |
| 10622382 | 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. |
| 17171947 | 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. |
| 10051276 | 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. |
| 10903232 | 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. |
| 10794325 | 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. |
| 8782638 | 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. |