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

Heart Failure Clinical Trial

— dyvic2  

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: NCT04484298
• Other study ID #: DYVIC2
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2021
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• Reference 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)
• nitroglucerin
0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.

Locations

Country	Name	City	State
Tunisia	Emergency department of fattouma bourguiba university hospital	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 variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups	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.	24 hours
Primary	roc curve	Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.	24
Primary	Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of 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 hours