Congestive Heart Failure, COPD, Sepsis, Stroke, Trauma
Conditions
Keywords
Non-invasive hemodynamic monitoring, Emergency Department patients, trauma with an ISS>15, Non-invasive continuous hemodynamic monitoring
Brief summary
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
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.
Interventions
DEVICENexfinHD Monitor
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.
Sponsors
BMEYE, Amsterdam The Netherlands
Henry Ford Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed