Acute Heart FailureDYVICNCT03241069
Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)
A study testing Reference position, sitting position and Valsalva maneuver in people with Acute Heart Failure, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Reference position, sitting position and Valsalva maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteTunisia
- Study dates
- Jul 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year old or above
- non traumatic acute dyspnea
Who cannot join
- age <18 years,
- cardio respiratory arrest,
- coma,
- shock,
- need for inotropic or vasoactive drugs,
- mechanical ventilation,
Show all 10Show fewer
- severe and sustained rhythm disorders,
- severe mitral valve disease,
- severe pulmonary arterial hypertension
- renal insufficiency with creatinine>150 μmol/l.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Reference position, sitting position, Valsalva maneuver, a passive leg rising maneuver
- Keywords
- bio-impedance, BIOPAC system, dyspnea, acute heart failure
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference positionOther
Also called baseline position
patient is put in a 30 degree supine position during 5 minutes
sitting positionOther
patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured
Valsalva maneuverOther
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 maneuverOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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.) Receives: 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.) Receives: Other: Reference position; Other: sitting position; Other: a passive leg rising maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours
Secondary outcomes (1)
In hospital death
survivor or ,ot
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startJul 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Samir, Profesor, Principal investigator, University hospital of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241069
- Sponsor's protocol ID
- DYVIC
- Acronym
- DYVIC
- Status last verified
- Oct 2020
- First submitted
- 7 Sep 2013
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03241069
- Acronym / sponsor ID
- DYVIC / DYVIC
- Conditions
- Acute Heart Failure
- Keywords
- bio-impedance, BIOPAC system, dyspnea, acute heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients with acute dyspnea | Experimental | Other: Reference positionpatients 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 sitting position | Experimental | Other: Reference position, Other: Valsalva maneuver, Other: a passive leg rising maneuverthe 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) |
| a passive leg rising maneuver | Experimental | Other: Reference position, Other: sitting position, Other: Valsalva maneuverwe 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.) |
| Valsalva maneuver | Experimental | Other: Reference position, Other: sitting position, Other: a passive leg rising maneuverthe 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 year old or above
- non traumatic acute dyspnea
Key exclusion criteria (10 listed)
- age <18 years,
- cardio respiratory arrest,
- coma,
- shock,
- need for inotropic or vasoactive drugs,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reference positionAlso: baseline positionpatient is put in a 30 degree supine position during 5 minutes | Other | Valsalva maneuver, a passive leg rising maneuver, patients with acute dyspnea, the sitting position |
| sitting positionpatient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured | Other | Valsalva maneuver, a passive leg rising maneuver |
| Valsalva maneuverpatients 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 | a passive leg rising maneuver, the sitting position |
| a passive leg rising maneuverwe 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.) | Other | Valsalva maneuver, the sitting position |
Primary outcome
Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups
Time frame: 12 hours
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.
1 secondary outcome
In hospital death
Time frame: up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- official department websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira Samir, Profesor principal investigator
University hospital of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference position, sitting position and Valsalva maneuver in people with Acute Heart Failure, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.