Use of Non Invasive Hemodynamic Cardiovascular Monitoring to Evaluate Emergency Department Patients
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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 |
- 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 ]
- 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 |
Acutely ill or injured Emergency Department patients
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| United States, Michigan | |
| Henry Ford Hospital Emergency Department | |
| Detroit, Michigan, United States, 48202 | |
| 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:
|
Emergencies Heart Failure Sepsis Stroke Disease Attributes Pathologic Processes Heart Diseases Cardiovascular Diseases |
Infection Systemic Inflammatory Response Syndrome Inflammation Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013