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

NCT03241069 | Completed DMC

• 1 other identifier: DYVIC
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure

Keywords

bio-impedance; BIOPAC system; dyspnea; acute heart failure

Outcome Measures

Primary Outcomes (1)

• Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups

  The diagnostic performance of each maneuver 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. The diagnosis of AHF is based on clinical, biological (BNP levels), radiological (chest X-ray) and cardiac ultrasound data.

  12 hours

Secondary Outcomes (1)

• In hospital death

  up to 10 days

Study Arms (4)

patients with acute dyspnea

EXPERIMENTAL

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.

Other: Reference position

the sitting position

EXPERIMENTAL

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)

Other: Reference position; Other: Valsalva maneuver; Other: a passive leg rising maneuver

a passive leg rising maneuver

EXPERIMENTAL

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.)

Other: Reference position; Other: sitting position; Other: Valsalva maneuver

Valsalva maneuver

EXPERIMENTAL

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.)

Other: Reference position; Other: sitting position; Other: a passive leg rising maneuver

Interventions

Reference position OTHER

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

Also known as: baseline position

Valsalva maneuver; a passive leg rising maneuver; patients with acute dyspnea; the sitting position

sitting position OTHER

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

Valsalva maneuver; a passive leg rising maneuver

Valsalva maneuver 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; the sitting position

a passive leg rising maneuver 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.)

Valsalva maneuver; the sitting position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old or above
• non traumatic acute dyspnea

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Emergency Department

Monastir, 5000, Tunisia

Location

Related Links

• official department website

MeSH Terms

Conditions

Dyspnea

Interventions

Sitting Position; Valsalva Maneuver

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Respiratory Physiological Phenomena

Study Officials

• Nouira Samir, Profesor

  University hospital of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2013
• First Posted: August 7, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 2, 2021

Record last verified: 2020-10

Locations

TU (1)