dyvic2: Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)

Sponsor

University of Monastir (Other)

Overall Status

Completed

CT.gov ID

NCT04484298

Collaborator

(none)

100

Enrollment

Location

Arms

13.9

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Diagnostic Test: Reference position patient is put in a 30 degree supine position during 5 minutes Diagnostic Test: nitroglucerin	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jan 2, 2019

Actual Primary Completion Date :

Feb 29, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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)
Experimental: 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.	Diagnostic Test: nitroglucerin 0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.

Arm

Intervention/Treatment

Experimental: 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.

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)

Experimental: 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.

Diagnostic Test: nitroglucerin

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

Outcome Measures

Primary Outcome Measures

Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups [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.
roc curve [24]
Receiver 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.