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| Name | Class |
|---|---|
| BMEYE, Amsterdam The Netherlands | UNKNOWN |
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This study is an observational prospective pilot trial that utilizes finger cuff non invasive hemodynamic monitoring (NexfinHD Monitor) to assess 4 different groups (CHF/COPD, Trauma, Sepsis, Stroke) of patients on arrival to the Emergency Department and to document the changes seen in these hemodynamics with acute therapies.
There has been little very early (after Emergency Department presentation) hemodynamic monitoring of acutely ill or injured patients secondary to the lack of non invasive technologies that could be reliably applied to this patient population.Thus all assessments of hemodynamics have been made by physicians on clinical information including intermittent pulse and blood pressure measurements. It is not known what the underlying continuous cardiac output, systemic vascular resistance, etc are in these patients and how these change with current Emergency Medicine therapeutic interventions. Currently there is available a finger cuff devise (NexfinHD Monitor, BMEYE, Amsterdam) that can measure these hemodynamics on a beat to beat basis and that can be easily applied to acutely ill individuals. This prospective pilot study of 48 patients (4 groups of 12 each) will document the hemodynamics of patients on arrival and continuously for 2 hours, blinded to the treating physician. Treating physicians will be asked to estimate these hemodynamic parameters at various time points. The study will characterize the hemodynamics of patients, compare them to the estimates of treating physicians and determine whether they predict the need for life saving interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute CHF/COPD | Patients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD |
| |
| Acute Trauma | Acute trauma patients with a trauma ISS>15 |
| |
| Sepsis | Patients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea) |
| |
| Stroke | Patients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NexfinHD Monitor | Device | Finger cuff device (NexfinHD Monitor, BMEYE, Amsterdam) that can measure hemodynamics on a beat to beat basis and that can be easily applied to acutely ill individuals. |
| Measure | Description | Time Frame |
|---|---|---|
| To elucidate the hemodynamics of the cohort of four different groups of patients in the early hours of their presentation | Emergency Department (ED) arrival to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of clinical estimation of hemodynamics and values estimated by the NexfinHD on arrival and for up to 6 hours | ED arrival to 6 hours | |
| To compare if abnormal hemodynamics as measured by the NexfinHD and clinical assessment after arrival to the ED in the 4 groups predicts life saving interventions within 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Acutely ill or injured Emergency Department patients
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Nowak, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital Emergency Department | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21802881 | Derived | Nowak RM, Sen A, Garcia AJ, Wilkie H, Yang JJ, Nowak MR, Moyer ML. Noninvasive continuous or intermittent blood pressure and heart rate patient monitoring in the ED. Am J Emerg Med. 2011 Sep;29(7):782-9. doi: 10.1016/j.ajem.2011.05.014. Epub 2011 Jul 29. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| D014947 | Wounds and Injuries |
| D018805 | Sepsis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| ED arrival to 2 hours |
| To calculate short term hemodynamic variability parameters and their prediction of life saving interventions within 2 hours and subjective/objective estimation of clinical improvement | ED arrival to 2 hours |
| Estimation of bias and precision of the non invasive hemodynamic trends in unselected patient group by assessing the validity of measurements with invasive measurements if used | ED arrival to 2 hours |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |