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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Reference position patient is put in a 30 degree supine position during 5 minutes
nitroglucerin
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Emergency department of fattouma bourguiba university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

reference group

TRINITRINE

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.

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.

Outcomes

Primary Outcome Measures

Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups
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
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.
Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2020
Last Updated
March 26, 2021
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT04484298
Brief Title
Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)
Acronym
dyvic2
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
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
March 1, 2020 (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
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
reference group
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
TRINITRINE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Reference position patient is put in a 30 degree supine position during 5 minutes
Intervention Description
Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO)
Intervention Type
Diagnostic Test
Intervention Name(s)
nitroglucerin
Intervention Description
0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.
Primary Outcome Measure Information:
Title
Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups
Description
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.
Time Frame
24 hours
Title
roc curve
Description
Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.
Time Frame
24
Title
Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.
Description
Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nouira semir, MD
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency department of fattouma bourguiba university hospital
City
Monastir
ZIP/Postal Code
5020
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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