Non-Invasive Shunt Quantification in Interatrial Communication (NISQIC)

October 7, 2022 updated by: University Hospital, Clermont-Ferrand

Shunt Quantification in Atrial Septal Defect Using Inert Gas Rebreathing and Thoracic Bioimpedance: Comparison With the Gold Standard Method

Shunt quantification in atrial septal defect (ASD) is estimated by Echocardiography-Doppler, with the pulmonary-to-systemic blood flow ratio: Qp/Qs. Higher is the ratio, more important is the shunt, and the consequence on right ventricular function. A value higher than 1.5 is one of the criteria for percutaneous closure of Secundum ASD. Maatouk and al. have demonstrated that a shunt fraction (Qp/Qs) over 3 is a predictive factor of an incomplete reversibility of the right ventricular remodeling [1]. Even if the accuracy of Doppler echocardiography is admitted for Qp/Qs measurement, there is still some technical difficulties. Thus, the right cardiac catheterization for O2 consumption measurement by the direct Fick method is used. The major inconvenient is the potential risk of adverse effects. Non-invasive methods have been developed using physical properties (as the thoracic bioimpedance) or inert gas rebreathing technique. Thoracic Bioimpedance (TB) and inert gas rebreathing (IGR) techniques have been studies on healthy individual and different respiratory or cardiac diseases to evaluate the cardiac output (CO). TB and IGR measure the systemic and pulmonary blood flow respectively. Without shunt the pulmonary blood flow is equal to the systemic blood flow.

Thus, Investigator suppose that combine the two techniques in disease with shunt, will allow a quantification of the shunt fraction Qp/Qs as accurate as with the gold standard technique (Fick method and Echocardiography Doppler).

The purpose of the study is to evaluate the feasibility and the accuracy of the non-invasive measurement of the Qp/Qs ratio in secundum ASD using the IGR technique and the TB versus the two gold standard techniques: the Fick method and the Echocardiography-Doppler.

The study hypothesizes that the values of Qp et Qs determined by IGR et TB respectively are in the same range of values that the one determined by gold standard techniques.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Shunt quantification and their hemodynamic consequences have a major importance in the evaluation of heart diseases. Atrial septal defect (ASD) has an intracardiac left-to right shunt, leading to an over pulmonary output with ventricular and pulmonary effects. Measurements of the LTR in ASD requires the determination of the pulmonary blood flow (Qp) and the systemic blood flow (Qs).

Two gold standard techniques are usually used to measure the pulmonary to systemic blood flow ratio (Qp/Qs): either invasive by performing a right heart catheterization, with the direct Fick method, or non-invasive by using the Echocardiography-Doppler (ED) First determine by ED by the successively measure of the Qp at the pulmonary annular and the Qs at the aortic annular, this technique is largely available, reproducible and accurate.

However, some limits are pointed with this non-invasive gold standard method: underestimation of shunt quantification in case of large septal defect, the accuracy depends on the operator experience, the lack of precision to measure pulmonary annular area especially on adults leading to a wrong measure of the pulmonary blood flow.

In case of doubt about pulmonary hypertension or difficulties in hemodynamic evaluation, the cardiologists perform a right heart catheterization to measure the CO by the Fick method .

Concerning the other non-invasive approach, thoracic bioimpedance (TB) have been developed in the middle of the twenty-one centuries by Kubiceck to measure cardiovascular parameters in astronauts has been largely study. Moreover, hemodynamic parameters are not stable but varies continuously according to the "hemodynamic state".

High of interest in the field of the non-invasive hemodynamic device, Inert gas rebreathing (IGR) measures the pulmonary blood flow, at rest and on exercise in healthy patient and different cardiorespiratory diseases. The Innocor® (Innovision, Odense, Denmark) uses a rebreathing bag containing a mixing of N2O (0,5%) SF6 (0,1%) and O2 (28%) diluted with atmospheric air. At the steady state of the insoluble inert gas, sulphur hexafluoride SF6, the wash out rate of N2O during rebreathing is calculated, which is proportional to the Qp. Many studies on healthy people confirms its accuracy, safety, reproducibility to measure CO . Agostoni et al. assess the Innocor® on patients with stable heart failure at rest and exercise comparatively to Thermodilution (ThD) and Fick method . They found a good correlation between the three methods at exercise. They found a tendency on underestimation of the IGR technique for CO measurement in comparison to Fick method . Few studies are available on the IGR technique use in CHD population. Tested on a paediatric population, investigators have proved its feasibility on exercise.Secondary they focused on ASD paediatric population. The CO were measured at exercise before and after percutaneous or surgical closured. They confirm the reproducibility, and feasibility of the IGR . Investigators found a similar agreement with the Fick method for patients with CHD without shunting or with right-to-left shunt .

To our knowledge, no study has focused on the concomitant used of two non-invasive technique to measure the shunt fraction in diseases with shunt. Some have suggested the interest of such a method in chronic obstructive pulmonary disease (COPD) .In fact, CO measured at rest and exercise shows a statistical difference between the IGR and TB due to the shunt effect and right-to-left shunt in COPD. Thus, the IGR and TB determine a pulmonary cardiac output (Qp) and a systemic cardiac output (Qs) respectively.

Based on these results, Investigator hypothesis that the combined used of the IGR and TB will enhance the precision and accuracy of the shunt fraction measurement.

The aim of this study is to validate the double non-invasive pulmonary-to-systemic ratio measurements on ostium secundum ASD in comparison to the two-gold standard method: the direct Fick method and the Echocardiography-Doppler.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU clermont-ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cooperate patients over 18 years, having a OS ASD with an indication of interventional closure according to the European Cardiology society guidelines of 2010.
  • Patients with significant shunt (signs of right ventricular volume overload) and Pulmonary Vascular Resistance (PVR) <5WU
  • ASD, regardless the size, with suspicion of paradoxal embolism
  • Patients with PVR > or egal 5 WU but <2/3 Systemic Vascular Resistance or Pulmonary Arterial Pressure < 2/3 systemic pressure and evidence of net Left-to Right shunt (Qp/Qs > 1,5)
  • with the French Social Security System

Exclusion Criteria:

  • Pregnant women and breastfeeding women
  • Difficulties of cooperation (patient under assisted ventilation)
  • Chronic Obstructive Pulmonary disease or respiratory failure
  • Complex congenital heart disease
  • Antiplatelet contraindication
  • Patients under protection, vulnerable patients
  • No consent
  • Contraindication of the non-invasive devices
  • Physioflow (Manatec, France): patients with pacemaker, with a cardiorespiratory support and assistance, severe aortic insufficiency
  • Innocor (Innovision, Odense, Denmark): to our knowledge, and according to the user instructions, there is no contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with Atrial septal defect type Ostium Secundum
patients with Atrial septal defect type Ostium Secundum, eligible for an interventional closure
Device: Innocor®
Inert gas rebreathing device: Innocor® (Innovision, Odense, Denmark)
Device: Physioflow®
Bioimpedance cardiograph: Physioflow® (Manatec, France)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shunt fraction
Time Frame: at 1 hour
Accuracy of Qp/Qs ratio measurements by the double non-invasive technique and the gold standard method (non-invasive: Echocardiography Doppler; invasive: direct Fick method) before interventional closure of ASD
at 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shunt fraction Qp/Qs after closure
Time Frame: at 1 hour
Qp/Qs measurements by the double non-invasive technique in comparison to Echocardiography-Doppler after interventional closure
at 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Sport Medicine Department, CHU Clermont-Ferrand
Cardiology and Vascular Department, CHU Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Actual)

April 6, 2022

Study Completion (Actual)

October 3, 2022

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-373
  • 2017-A03149-44 (Other Identifier: 2017-A03149-44)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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