Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome

Summary

Pulmonary distension induced by mechanical ventilation physiologically alters right ventricle pre and after-load, hence might lead to right ventricle failure. The hypothesis is that in Acute Respiratory Distress Syndrome, the occurence of a right ventricle failure under lung protective ventilation might :

i) be correlated to the transpulmonary pressure level, ii) lead to global heart failure, iii) and extremely result in poor outcome and death.

The primary objective is to test the impact of transpulmonary pressure on right ventricular function in Acute Respiratory Distress Syndrome in adults and children.

Secondary objectives are :

i) to compare thresholds of transpulmonary pressure associated with right ventricle failure between children and adults.

ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.

\- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:

* To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
* To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

OTHER

Pneumotachograph

Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management : * The first measurement will be performed 5 minutes after the initial ventilator settings. * Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution. * An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).

OTHER

Esophageal catheter

Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management * The first measurement will be performed 5 minutes after the initial ventilator settings. * Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution. * An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).

OTHER

Transthoracic and / or transesophageal cardiac ultrasound

The right ventricle systolic function will be assessed thanks to a transthoracic cardiac ultrasound in children, and a transthoracic of a transesophageal cardiac ultrasound in adults : Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management : * The first measurement will be performed 5 minutes after the initial ventilator settings. * Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution. * An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures).

OTHER

Electrical impedance tomography (EIT) for pediatric patients

For pediatric patients: measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management.

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Meryl Vedrenne-Cloquet, MD · Assistance Publique - Hôpitaux de Paris

• Brigitte Fauroux, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-11

Primary Completion

2022-06-11

Completion

2022-06-11

Countries

• France

Study Locations