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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04484298
Acronym
dyvic2
Enrollment
100
Registered
2020-07-23
Start date
2019-01-02
Completion date
2020-03-01
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

dyspnea, acute, heart failure, bio-impedance, biopac system

Brief summary

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.

Detailed description

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.

Interventions

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

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

DIAGNOSTIC_TESTnitroglucerin

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

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups24 hoursthe 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.
roc curve24Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.
Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.24 hoursSensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026