Use of Non Invasive Hemodynamic Cardiovascular Monitoring to Evaluate Emergency Department Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessments of Early Hemodynamics in Emergency Department Patients and Evaluation of Trends and Variability in Prediction of Life-saving Interventions

Conditions
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COPD, Congestive Heart Failure, Trauma, Sepsis, Stroke

Intervention / Treatment
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* Device: NexfinHD Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute CHF/COPD (n=12) Patients with acute trauma and a trauma ISS>15 (n=12) Patients with acute sepsis (n=12) Patients with acute stroke (n=12) Exclusion Criteria: Patients in cardiopulmonary arrest patients with STEMI Patients with known peripheral vascular disease Pregnant patients Age<18 Excessively agitated patients Interference with current standard of acre

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute CHF/COPD<br>Patients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD | Device: NexfinHD Monitor<br>* 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.<br>* Other names: Transcient Ischemic Attack;|
| Acute Trauma<br>Acute trauma patients with a trauma ISS>15 | Device: NexfinHD Monitor<br>* 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.<br>* Other names: Transcient Ischemic Attack;|
| Sepsis<br>Patients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea) | Device: NexfinHD Monitor<br>* 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.<br>* Other names: Transcient Ischemic Attack;|
| Stroke<br>Patients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic) | Device: NexfinHD Monitor<br>* 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.<br>* Other names: Transcient Ischemic Attack;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive hemodynamic monitoring, Emergency Department patients, trauma with an ISS>15, Non-invasive continuous hemodynamic monitoring