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

Primary Purpose

Acute Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Reference position
sitting position
Valsalva maneuver
a passive leg rising maneuver
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Heart Failure focused on measuring bio-impedance, BIOPAC system, dyspnea, acute heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

patients with acute dyspnea

the sitting position

a passive leg rising maneuver

Valsalva maneuver

Arm Description

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.

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)

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.)

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.)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

In hospital death
survivor or ,ot

Full Information

First Posted
September 7, 2013
Last Updated
July 25, 2021
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT03241069
Brief Title
Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)
Acronym
DYVIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
bio-impedance, BIOPAC system, dyspnea, acute heart failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with acute dyspnea
Arm Type
Experimental
Arm Description
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.
Arm Title
the sitting position
Arm Type
Experimental
Arm Description
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)
Arm Title
a passive leg rising maneuver
Arm Type
Experimental
Arm Description
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.)
Arm Title
Valsalva maneuver
Arm Type
Experimental
Arm Description
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.)
Intervention Type
Other
Intervention Name(s)
Reference position
Other Intervention Name(s)
baseline position
Intervention Description
patient is put in a 30 degree supine position during 5 minutes
Intervention Type
Other
Intervention Name(s)
sitting position
Intervention Description
patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured
Intervention Type
Other
Intervention Name(s)
Valsalva maneuver
Intervention Description
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
Intervention Name(s)
a passive leg rising maneuver
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups
Description
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.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
In hospital death
Description
survivor or ,ot
Time Frame
up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Samir, Profesor
Organizational Affiliation
University hospital of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.urgencemonastir.com
Description
official department website

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

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