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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851214
• Other study ID #: HFH DEM 001
• Status: Completed
• Phase: N/A
• First received: February 24, 2009
• Last updated: February 17, 2010
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: March 2009
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• COPD
• Emergencies
• Heart Failure
• Sepsis
• Stroke
• Trauma

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Hospital Emergency Department	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	BMEYE, Amsterdam The Netherlands

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No