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

February 24, 2009
February 17, 2010
March 2009
June 2009   (final data collection date for primary outcome measure)
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 ]
To elucidate the hemodynamics of the cohort of four different groups of patients in the early hours of their presentation [ Time Frame: Emergenct Department (ED) arrival to 2 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00851214 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Use of Non Invasive Hemodynamic Cardiovascular Monitoring to Evaluate Emergency Department Patients
Assessments of Early Hemodynamics in Emergency Department Patients and Evaluation of Trends and Variability in Prediction of Life-saving Interventions

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Acutely ill or injured Emergency Department patients

  • COPD
  • Congestive Heart Failure
  • Trauma
  • Sepsis
  • Stroke
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 CHF/COPD
    Patients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD
    Intervention: Device: NexfinHD Monitor
  • Acute Trauma
    Acute trauma patients with a trauma ISS>15
    Intervention: Device: NexfinHD Monitor
  • Sepsis
    Patients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea)
    Intervention: Device: NexfinHD Monitor
  • Stroke
    Patients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic)
    Intervention: Device: NexfinHD Monitor
Nowak RM, Sen A, Garcia AJ, Wilkie H, Yang JJ, Nowak MR, Moyer ML. Noninvasive continuous or intermittent blood pressure and heart rate patient monitoring in the ED. Am J Emerg Med. 2011 Sep;29(7):782-9. doi: 10.1016/j.ajem.2011.05.014. Epub 2011 Jul 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00851214
HFH DEM 001
No
Richard M. Nowak MD, Henry Ford Hospital
Henry Ford Health System
BMEYE, Amsterdam The Netherlands
Principal Investigator: Richard M Nowak, MD Henry Ford Health System
Henry Ford Health System
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP