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

NCT ID: NCT00851214

Last Updated: 2010-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COPD Congestive Heart Failure Trauma Sepsis Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute CHF/COPD

Patients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD

NexfinHD Monitor

Intervention Type DEVICE

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.

Acute Trauma

Acute trauma patients with a trauma ISS\>15

NexfinHD Monitor

Intervention Type DEVICE

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.

Sepsis

Patients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea)

NexfinHD Monitor

Intervention Type DEVICE

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.

Stroke

Patients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic)

NexfinHD Monitor

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Transcient Ischemic Attack

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BMEYE, Amsterdam The Netherlands

UNKNOWN

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Henry Ford Hospital

Principal Investigators

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Richard M Nowak, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Hospital Emergency Department

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21802881 (View on PubMed)

Other Identifiers

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HFH DEM 001

Identifier Type: -

Identifier Source: org_study_id

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