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

Completed
Conditions
Trauma
Sepsis
COPD
Stroke
Congestive Heart Failure
Interventions
Device: NexfinHD Monitor
Registration Number
NCT00851214
Lead Sponsor
Henry Ford Health System
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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)
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
SepsisNexfinHD MonitorPatients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea)
StrokeNexfinHD MonitorPatients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic)
Acute CHF/COPDNexfinHD MonitorPatients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD
Acute TraumaNexfinHD MonitorAcute trauma patients with a trauma ISS\>15
Primary Outcome Measures
NameTimeMethod
To elucidate the hemodynamics of the cohort of four different groups of patients in the early hours of their presentationEmergency Department (ED) arrival to 2 hours
Secondary Outcome Measures
NameTimeMethod
To calculate short term hemodynamic variability parameters and their prediction of life saving interventions within 2 hours and subjective/objective estimation of clinical improvementED 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 usedED arrival to 2 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 hoursED arrival to 2 hours
Comparison of clinical estimation of hemodynamics and values estimated by the NexfinHD on arrival and for up to 6 hoursED arrival to 6 hours

Trial Locations

Locations (1)

Henry Ford Hospital Emergency Department

🇺🇸

Detroit, Michigan, United States

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