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.

Study Overview

• Status: Completed
• Conditions: Stroke; Sepsis; Trauma; COPD; Congestive Heart Failure
• Intervention / Treatment: Device: NexfinHD Monitor

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acutely ill or injured Emergency Department patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: Transcient Ischemic Attack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To elucidate the hemodynamics of the cohort of four different groups of patients in the early hours of their presentation	Emergency Department (ED) arrival to 2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of clinical estimation of hemodynamics and values estimated by the NexfinHD on arrival and for up to 6 hours	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	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	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	ED arrival to 2 hours

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: BMEYE, Amsterdam The Netherlands

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: February 24, 2009
• First Submitted That Met QC Criteria: February 24, 2009
• First Posted (Estimate): February 25, 2009

Study Record Updates

• Last Update Posted (Estimate): February 18, 2010
• Last Update Submitted That Met QC Criteria: February 17, 2010
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Non-invasive hemodynamic monitoring; Emergency Department patients; trauma with an ISS>15; Non-invasive continuous hemodynamic monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Heart Failure; Emergencies
• Other Study ID Numbers: HFH DEM 001