Clinical trial NCT00851214: Use of Non Invasive Hemodynamic Cardiovascular Monitoring to Evaluate Emergency Department Patients
Official title: Assessments of Early Hemodynamics in Emergency Department Patients and Evaluation of Trends and Variability in Prediction of Life-saving Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Congestive Heart Failure
Trauma
Sepsis
Stroke
Keywords: Non-invasive hemodynamic monitoring
Emergency Department patients
trauma with an ISS>15
Non-invasive continuous hemodynamic monitoring
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: BMEYE, Amsterdam The Netherlands
First posted: 2009-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acutely ill or injured Emergency Department patients

Brief 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.

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 criteria: 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

Primary outcomes:
measure: To elucidate the hemodynamics of the cohort of four different groups of patients in the early hours of their presentation
timeFrame: Emergency Department (ED) arrival to 2 hours
Secondary outcomes:
measure: Comparison of clinical estimation of hemodynamics and values estimated by the NexfinHD on arrival and for up to 6 hours
timeFrame: ED arrival to 6 hours
measure: 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
timeFrame: ED arrival to 2 hours
measure: To calculate short term hemodynamic variability parameters and their prediction of life saving interventions within 2 hours and subjective/objective estimation of clinical improvement
timeFrame: ED arrival to 2 hours
measure: 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
timeFrame: ED arrival to 2 hours
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital Emergency Department
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Richard M Nowak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.