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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • NexfinHD Monitor Device
    Other Names: Transcient Ischemic Attack
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Acute CHF/COPD
    Description: Patients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD
    ARM 2: Kind: Experimental
    Label: Acute Trauma
    Description: Acute trauma patients with a trauma ISS>15
    ARM 3: Kind: Experimental
    Label: Sepsis
    Description: Patients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea)
    ARM 4: Kind: Experimental
    Label: Stroke
    Description: Patients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic)

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Acutely ill or injured Emergency Department patients

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No

Sponsors