Validation of intracardiac shunt using thoracic bioimpedance and inert gas rebreathing in adults before and after percutaneous closure of atrial septal defect in a cardiology research unit: study protocol

Laura Filaire, Aurelie Chalard, Hélène Perrault, Romain Trésorier, Jean-René Lusson, Bruno Pereira, Frederic Costes, Claire Dauphin, Ruddy Richard, Laura Filaire, Aurelie Chalard, Hélène Perrault, Romain Trésorier, Jean-René Lusson, Bruno Pereira, Frederic Costes, Claire Dauphin, Ruddy Richard

Abstract

Introduction: Intrathoracic shunt quantification is a major factor for appropriate clinical management of heart and pulmonary diseases. Intracardiac shunts quantified by pulmonary to systemic output ratio (Qp/Qs) are generally assessed by Doppler echocardiography, MRI or catheterisation. Recently, some authors have suggested the concomitant use of thoracic bioimpedance (TB) and inert gas rebreathing (IGR) techniques for shunt quantification. The purpose of this study is to validate the use of this approach under conditions where shunt fraction is directly quantified such as in patients with isolated atrial septal defect (ASD).

Methods and analysis: This trial is a prospective, observational single-centre, non-blinded study of adults seen for percutaneous closure of ASD. Qp/Qs ratio will be directly measured by Doppler echocardiography and direct Fick. IGR and TB will be used simultaneously to measure the cardiac output before and after closure: the ratio of outputs measured by IGR and TB reflecting the shunt fraction. The primary outcome will be the comparison of shunt values measured by TB-IGR and Doppler echocardiography.

Ethics and dissemination: The study has been approved by an independent Research Ethics Committee (2017-A03149-44 Fr) and registered as an official clinical trial. The results will be published in a peer-reviewed journal.

Trial registration number: NCT03437148; Pre-results.

Keywords: atrial septal defect (ASD); cardiac output; inert gas rebreathing; shunt quantification; thoracic bioimpedance.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Consort diagram: flow chart. Patients indicated to ASD percutaneous closure will be proposed to the study. Three assessments of the ratio with the concomitant use of IGR and TB are planned during a 3-days hospitalization: the day before and after intervention in comparison to the Doppler Cardiac Ultrasound measure and one the day of intervention in comparison to the direct Fick method. ASD: atrial septal defect.
Figure 2
Figure 2
Illustration of the thoracic cardiovascular circulation in Atrial septal defect (arrow). The blue frame represents the pulmonary circulation measured with the IGR (Innocor®) and the red frame the systemic circulation measured with the TB (Physioflow®). 1. Right side of the heart; 2. Vena cava; 3. Pulmonary artery; 4. Trachea; 5. Lung; 6. Pulmonary Veins; 7. Left side of the heart; 8. Aorta.

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