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

This study has been completed.
Sponsor:
Collaborator:
BMEYE, Amsterdam The Netherlands
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00851214
First received: February 24, 2009
Last updated: February 17, 2010
Last verified: March 2009
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Henry Ford Health System

Additional 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
Study First Received: February 24, 2009
Last Updated: February 17, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014