- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03241069
Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF) (DYVIC)
Dynamic Variation of Impedance Cardiography (ICG) a Diagnostic Tool of Acute Heart Failure (AHF) in Emergency Department (ED) Patients Admitted for Acute Dyspnea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acute heart failure (AHF) is a frequent condition in emergency basis and is responsible of a big number of admissions, complications, and deaths.
despite advances in diagnostic techniques, AHF diagnosis still difficult and cost not effective.
Measurement of cardiac output (CO) is used as a way to evaluate global cardiac function and changes in CO may be used to identify a change in the hemodynamic status of a patient.
the gold standard of measuring CO is thermodilution catheterization, however this is an invasive technique that poses a risk to the patient.
Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by applying small electrical current to the chest, and through electrodes placed on the neck and sides.
the pulsatile flow of blood causes fluctuations in the current, and the device calculates CO from the impedance waveform.
In practice, the investigators connect the device "BIOPAC" by using four electrodes which the investigators place on the base of the neck (posterior face) and on the base of the thorax (posterior face).
The ECG recording is taken simultaneously with two other electrodes placed at the right upper limb and left lower limb.
In addition to detecting the electric current and the ECG, heart sounds are recorded using a sensor that is placed at the mitral site.
The various curves are displayed simultaneously and stored for analysis. Subjects were first placed in the semi sitting position 30°, and after 5 minutes had cardiac output measurements performed. (CO1)
A second cardiac output measurement was performed after 5 min of seated position. (C02)
Patients were then placed in the initial position, and after an additional 5 minutes had cardiac output measurements performed. (CO1')
A third set of measurement was obtained during 45° passive leg raising at 1 to 2 minutes.(CO3)
Patients were then placed in the initial position, and after an additional 5 minutes had cardiac output measurements performed. (CO1'')
During a Valsalva maneuver the investigators took the fourth cardiac output measurement. (CO4)
Patients were then placed in the initial position, and after an additional 5 minutes had cardiac output measurements performed. (CO1''')
Dynamic variations on bio-impedance measured CO using non pharmacologic intervention (sitting position, passive leg rising and Valsalva maneuver) could be used to detect AHF in patients admitted to the ED for dyspnea.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Monastir, Tunisia, 5000
- Emergency department
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 year old or above
- non traumatic acute dyspnea
Exclusion Criteria:
- age <18 years,
- cardio respiratory arrest,
- coma,
- shock,
- need for inotropic or vasoactive drugs,
- mechanical ventilation,
- severe and sustained rhythm disorders,
- severe mitral valve disease,
- severe pulmonary arterial hypertension
- renal insufficiency with creatinine>150 μmol/l.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients with acute dyspnea
patients presenting to the emergency department with acute onset dyspnea are assessed for acute heart failure using the bio impedance technology (BIOPAC system) to measure the cardiac output in different clinical situations. FIRST: the cardiac output (CO) is measured at the reference position. Inbetween each step the patient was put in the reference position during 5 minutes. |
patient is put in a 30 degree supine position during 5 minutes
Other Names:
|
Experimental: the sitting position
the patient is put at the sitting position and we measure the cardiac output by BIOPAC system (patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured 5 minutes later)
|
patient is put in a 30 degree supine position during 5 minutes
Other Names:
patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.
we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver.)
|
Experimental: a passive leg rising maneuver
we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver 5minutes later.)
|
patient is put in a 30 degree supine position during 5 minutes
Other Names:
patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.
patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured
|
Experimental: Valsalva maneuver
the patient was asked to perform the Valsalva maneuver and we measure the cardiac output by BIOPAC system(patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.)
|
patient is put in a 30 degree supine position during 5 minutes
Other Names:
we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver.)
patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups
Time Frame: 12 hours
|
The diagnostic performance of each maneuver is evaluated by calculating the CO in ml/min by bio-impedance technique and compare the values between patients with and without AHF and between baseline. The diagnosis of AHF is based on clinical, biological (BNP levels), radiological (chest X-ray) and cardiac ultrasound data. |
12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In hospital death
Time Frame: up to 10 days
|
survivor or ,ot
|
up to 10 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nouira Samir, Profesor, University Hospital of Monastir
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DYVIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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