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

NCT ID: NCT03241069

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-12-31

Brief Summary

Dynamic variations of bio-impedance measured cardiac output using non pharmacologic intervention (sitting position, passive leg rising and valsalva maneuver) could be used to detect acute heart failure in patients admitted to the ED for dyspnea.

Detailed Description

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

despite advances in diagnostic techniques, AHF diagnosis still difficult and cost not effective.

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

the gold standard of measuring CO is thermodilution catheterization, however this is an invasive technique that poses a risk to the patient.

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

The various curves are displayed simultaneously and stored for analysis. Subjects were first placed in the semi sitting position 30°, and after 5 minutes had cardiac output measurements performed. (CO1)

A second cardiac output measurement was performed after 5 min of seated position. (C02)

Patients were then placed in the initial position, and after an additional 5 minutes had cardiac output measurements performed. (CO1')

A third set of measurement was obtained during 45° passive leg raising at 1 to 2 minutes.(CO3)

Patients were then placed in the initial position, and after an additional 5 minutes had cardiac output measurements performed. (CO1'')

During a Valsalva maneuver the investigators took the fourth cardiac output measurement. (CO4)

Patients were then placed in the initial position, and after an additional 5 minutes had cardiac output measurements performed. (CO1''')

Dynamic variations on bio-impedance measured CO using non pharmacologic intervention (sitting position, passive leg rising and Valsalva maneuver) could be used to detect AHF in patients admitted to the ED for dyspnea.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

patients with acute dyspnea

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

Intervention Type: OTHER

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

the sitting position

the patient is put at the sitting position and we measure the cardiac output by BIOPAC system (patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured 5 minutes later)

Group Type: EXPERIMENTAL

Reference position

Intervention Type: OTHER

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

Valsalva maneuver

Intervention Type: OTHER

patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.

a passive leg rising maneuver

Intervention Type: OTHER

we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver.)

a passive leg rising maneuver

we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver 5minutes later.)

Group Type: EXPERIMENTAL

Reference position

Intervention Type: OTHER

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

sitting position

Intervention Type: OTHER

patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured

Valsalva maneuver

Intervention Type: OTHER

patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.

Valsalva maneuver

the patient was asked to perform the Valsalva maneuver and we measure the cardiac output by BIOPAC system(patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.)

Group Type: EXPERIMENTAL

Reference position

Intervention Type: OTHER

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

sitting position

Intervention Type: OTHER

patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured

a passive leg rising maneuver

Intervention Type: OTHER

we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver.)

Interventions

Reference position

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

Intervention Type: OTHER

sitting position

patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured

Intervention Type: OTHER

Valsalva maneuver

patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.

Intervention Type: OTHER

a passive leg rising maneuver

we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver.)

Intervention Type: OTHER

Other Intervention Names

baseline position

Eligibility Criteria

Inclusion Criteria

• 18 year old or above
• non traumatic acute dyspnea

Exclusion Criteria

• age <18 years,
• cardio respiratory arrest,
• coma,
• shock,
• need for inotropic or vasoactive drugs,
• mechanical ventilation,
• severe and sustained rhythm disorders,
• severe mitral valve disease,
• severe pulmonary arterial hypertension
• renal insufficiency with creatinine>150 μmol/l.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nouira Samir, Profesor

Role: PRINCIPAL_INVESTIGATOR

University hospital of Monastir

Locations

Emergency Department

Monastir, , Tunisia

Countries

Tunisia

Related Links

http://www.urgencemonastir.com

official department website

Other Identifiers

DYVIC

Identifier Type: -

Identifier Source: org_study_id