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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851214
First Posted: February 25, 2009
Last Update Posted: February 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BMEYE, Amsterdam The Netherlands
Information provided by:
Henry Ford Health System
  Purpose
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.

Condition Intervention
COPD Congestive Heart Failure Trauma Sepsis Stroke Device: NexfinHD Monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessments of Early Hemodynamics in Emergency Department Patients and Evaluation of Trends and Variability in Prediction of Life-saving Interventions

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 40
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute CHF/COPD
Patients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD
Device: NexfinHD 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.
Other Name: Transcient Ischemic Attack
Acute Trauma
Acute trauma patients with a trauma ISS>15
Device: NexfinHD 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.
Other Name: Transcient Ischemic Attack
Sepsis
Patients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea)
Device: NexfinHD 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.
Other Name: Transcient Ischemic Attack
Stroke
Patients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic)
Device: NexfinHD 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.
Other Name: Transcient Ischemic Attack

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acutely ill or injured Emergency Department patients
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851214


Locations
United States, Michigan
Henry Ford Hospital Emergency Department
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
BMEYE, Amsterdam The Netherlands
Investigators
Principal Investigator: Richard M Nowak, MD Henry Ford Health System
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard M. Nowak MD, Henry Ford Hospital
ClinicalTrials.gov Identifier: NCT00851214     History of Changes
Other Study ID Numbers: HFH DEM 001
First Submitted: February 24, 2009
First Posted: February 25, 2009
Last Update Posted: February 18, 2010
Last Verified: March 2009

Keywords provided by Henry Ford Health System:
Non-invasive hemodynamic monitoring
Emergency Department patients
trauma with an ISS>15
Non-invasive continuous hemodynamic monitoring

Additional relevant MeSH terms:
Heart Failure
Emergencies
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes