COPDNCT00851214
Use of Non Invasive Hemodynamic Cardiovascular Monitoring to Evaluate Emergency Department Patients
An observational study of COPD and Congestive Heart Failure, run by Henry Ford Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Congestive Heart Failure, Trauma
- What is being tested?
- NexfinHD Monitor
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acutely ill or injured Emergency Department patients
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Hospital Emergency Department
Detroit, Michigan, 48202
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Congestive Heart Failure, Trauma, Sepsis, Stroke
- Being tested
- NexfinHD Monitor
- Keywords
- Non-invasive hemodynamic monitoring, Emergency Department patients, trauma with an ISS>15, Non-invasive continuous hemodynamic monitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure, Wounds and Injuries, Sepsis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexfinHD MonitorDevice
Also called Transcient Ischemic Attack
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute CHF/COPD | Patients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD Receives: Device: NexfinHD Monitor | |
| Acute Trauma | Acute trauma patients with a trauma ISS>15 Receives: Device: NexfinHD Monitor | |
| Sepsis | Patients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea) Receives: Device: NexfinHD Monitor | |
| Stroke | Patients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic) Receives: Device: NexfinHD Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To elucidate the hemodynamics of the cohort of four different groups of patients in the early hours of their presentation
Measured: Emergency Department (ED) arrival to 2 hours
Secondary outcomes (4)
Comparison of clinical estimation of hemodynamics and values estimated by the NexfinHD on arrival and for up to 6 hours
Measured: 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
Measured: 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
Measured: 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
Measured: ED arrival to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- BMEYE, Amsterdam The Netherlands
- Investigators
- Richard M Nowak, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851214
- Sponsor's protocol ID
- HFH DEM 001
- Status last verified
- Mar 2009
- First submitted
- 24 Feb 2009
- Last updated
- 18 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21802881
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments of Early Hemodynamics in Emergency Department Patients and Evaluation of Trends and Variability in Prediction of Life-saving Interventions
- ClinicalTrials.gov ID
- NCT00851214
- Acronym / sponsor ID
- HFH DEM 001
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- BMEYE, Amsterdam The Netherlands
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute CHF/COPD | – | Device: NexfinHD MonitorPatients presenting with shortness of breath secondary to acute exacerbation of CHF/COPD |
| Acute Trauma | – | Device: NexfinHD MonitorAcute trauma patients with a trauma ISS>15 |
| Sepsis | – | Device: NexfinHD MonitorPatients presenting with a suspicion of acute sepsis (fever, tachycardia, tachypnea) |
| Stroke | – | Device: NexfinHD MonitorPatients presenting with symptoms and signs of acute stroke (thrombotic or hemorrhagic) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acutely ill or injured Emergency Department patients
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- Patients in cardiopulmonary arrest
- patients with STEMI
- Patients with known peripheral vascular disease
- Pregnant patients
- Age<18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NexfinHD MonitorAlso: Transcient Ischemic AttackFinger 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. | Device | Acute CHF/COPD, Acute Trauma, Sepsis, Stroke |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
- Derived from this study: PubMed 21802881Nowak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard M Nowak, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Congestive Heart Failure, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00851214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010.