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

NCT ID: NCT04484298

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-03-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

reference group

patients presenting to the emergency department with acute onset dyspnea are assessed for acute heart failure using the bio impedance technology (BIOPAC system) to measure the cardiac output in different clinical situations.

FIRST: the cardiac output (CO) is measured at the reference position. Inbetween each step the patient was put in the reference position during 5 minutes.

Group Type: EXPERIMENTAL

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

Intervention Type: DIAGNOSTIC_TEST

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

TRINITRINE

0.6 mg of nitroglycerin was given to the patient sublingual and we measure the cardiac output by BIOPAC system(0.6 mg of Nitroglycerin was administered sublingually and CO was evaluated.

Group Type: EXPERIMENTAL

nitroglucerin

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

nitroglucerin

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

professor semir nouira

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nouira semir, MD

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

Emergency department of fattouma bourguiba university hospital

Monastir, , Tunisia

Countries

Tunisia

Other Identifiers

DYVIC2

Identifier Type: -

Identifier Source: org_study_id