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Completed

NCT Number: NCT03241069

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reference position

Other

patient is put in a 30 degree supine position during 5 minutes

Other names: baseline position

sitting position

Other

patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured

Valsalva maneuver

Other

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

Other

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.)

Primary outcomes

  1. 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.

Secondary outcomes

  1. In hospital death

    Time frame: up to 10 days

    survivor or ,ot

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: DYVIC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2017
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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