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Completed

NCT Number: NCT04484298

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

the study aimed to evaluate the diagnostic performance of cardiac output (CO) change after the use of trinitrine in the diagnosis of heart failure patients with acute 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 of fattouma bourguiba university hospital

Monastir, 5020, Tunisia

About this study

Acute heart failure (AHF) is a frequent condition in emergency department and is responsible of high number of admissions, complications, and deaths.

despite advances in diagnostic techniques, AHF diagnosis still be challenging .

Measurement of cardiac output (CO) is used to evaluate global cardiac function and changes in CO may be used to identify a change in the hemodynamic status of patient.

the gold standard of measuring CO is thermodilution catheterization, however it is an invasive technique with high risks.

Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by applying small electrical current to the chest 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.

Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO). NTG (0.6 mg) is then given to the patient sublingually and CO measurement was repeated. CO is calculated by averaging three measurements at one minute intervals at baseline and after NTG administration. DeltaCO was defined as the percent of change of baseline CO after NTG test.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 year old or above non traumatic acute dyspnea

Exclusion criteria

  • ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours,
  • pericardial effusion ,
  • chest wall deformity suspected of causing dyspnea,
  • coma,
  • need for mechanical ventilation or vasopressor drugs,
  • serious and sustained arrhythmia,
  • pace maker,
  • severe mitral valve disease, severe pulmonary arterial hypertension,
  • renal failure (creatinine >350µmol/l.

Treatment and study plan

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

Diagnostic Test

Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO)

nitroglucerin

Diagnostic Test

0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.

Primary outcomes

  1. Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups

    Time frame: 24 hours

    the diagnostic performance 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.

  2. roc curve

    Time frame: 24

    Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.

  3. Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.

    Time frame: 24 hours

    Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.

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: dyvic2

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2020
Registry last updated
Mar 29, 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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