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NCT Number: NCT00851214

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

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.

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Key information

Conditions

COPD Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Congestive Heart Failure Disease Attributes Heart Diseases Heart Failure Infections Inflammation Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Sepsis Stroke Systemic Inflammatory Response Syndrome Trauma Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Hospital Emergency Department

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Transcient Ischemic Attack

Primary outcomes

  1. To elucidate the hemodynamics of the cohort of four different groups of patients in the early hours of their presentation

    Time frame: Emergency Department (ED) arrival to 2 hours

Secondary outcomes

  1. Comparison of clinical estimation of hemodynamics and values estimated by the NexfinHD on arrival and for up to 6 hours

    Time frame: ED arrival to 6 hours

  2. 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

    Time frame: ED arrival to 2 hours

  3. To calculate short term hemodynamic variability parameters and their prediction of life saving interventions within 2 hours and subjective/objective estimation of clinical improvement

    Time frame: ED arrival to 2 hours

  4. 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

    Time frame: ED arrival to 2 hours

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • BMEYE, Amsterdam The Netherlands

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 25, 2009
Registry last updated
Feb 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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