Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)

Acute Heart Failure Clinical Trial

— DYVIC  

Official title:

Dynamic Variation of Impedance Cardiography (ICG) a Diagnostic Tool of Acute Heart Failure (AHF) in Emergency Department (ED) Patients Admitted for Acute Dyspnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241069
• Other study ID #: DYVIC
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2020
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dynamic variations of bio-impedance measured cardiac output using non pharmacologic intervention (sitting position, passive leg rising and valsalva maneuver) could be used to detect acute heart failure in patients admitted to the ED for dyspnea.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Other:
• Reference position
patient is put in a 30 degree supine position during 5 minutes
• sitting position
patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured
• Valsalva maneuver
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.
• 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.)

Locations

Country	Name	City	State
Tunisia	Emergency Department	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups	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	In hospital death	survivor or ,ot	up to 10 days

External Links

•   official department website