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

NCT ID: NCT04184674

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2022-06-11

Brief 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.

Detailed Description

Acute Respiratory Distress Syndrome (ARDS) is an acute inflammatory lung injury associated with a high pulmonary vascular permeability, leading to acute respiratory failure. Positive pressure mechanical ventilation,improves survival but might lead to ventilator-induced lung injury (VILI) and right ventricular failure. This hemodynamic effect is more important when compliance is decreased, especially in ARDS.

The use of long protective ventilation (with low tidal volumes and low plateau pressures) has improved prognosis of ARDS in adult patients. However, tidal volume and plateau pressures do not always reflect the lung deformation and the stress induced by the ventilation; these variables depend on the characteristics of the patient's respiratory system. Therefore, management focuses on ventilation strategies according to these characteristics.

Among tools used to evaluate respiratory physiological parameters, the esophageal pressure measurement is easily feasible at the bedside, and well estimates pleural pressure and pulmonary distension. During invasive ventilation, transpulmonary pressure (PL) can be obtained with the difference between the airway pressure and the esophageal pressure. Calculation of transpulmonary pressure in ARDS allows optimal ventilator management of adult and children treated for ARDS.

Although individualized ventilation techniques have shown some benefits in ARDS, studies have failed to show that survival could be improved by such strategies. This lack of efficacy could be partly explained by the hemodynamic impact of ventilation-induced pulmonary distension. It therefore seems essential to combine a robust assessment of right ventricular function with measurements of transpulmonary pressure in order to know the real hemodynamic impact of positive pressure ventilation in ARDS in adults and children.

The primary objective is to test the impact of transpulmonary pressure on right ventricular functionin ARDS adults and children.

Secondary objectives are :

i) to compare thresholds of transpulmonary pressure associated to 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Acute Respiratory Distress Syndrome

Children of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome.

Group Type: OTHER

Pneumotachograph

Intervention Type: OTHER

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).

Esophageal catheter

Intervention Type: OTHER

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).

Transthoracic and / or transesophageal cardiac ultrasound

Intervention Type: OTHER

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).

Electrical impedance tomography (EIT) for pediatric patients

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients over one month
• Patients with mild to severe ARDS (onset within 48 hours). ARDS definition will follow Berlin guidelines for adults, and Pediatric Acute Lung Injury Consensus Conference (PALICC) guidelines for children
• Signed consent

Exclusion Criteria

• Neonates less than 28 days-old
• Pregnancy or breastfeeding
• Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
• No social care

• Minimum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meryl Vedrenne-Cloquet, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Brigitte Fauroux, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

References

Vedrenne-Cloquet M, Petit M, Khirani S, Charron C, Khraiche D, Panaioli E, Habib M, Renolleau S, Fauroux B, Vieillard-Baron A. Impact of the transpulmonary pressure on right ventricle impairment incidence during acute respiratory distress syndrome: a pilot study in adults and children. Intensive Care Med Exp. 2024 Sep 27;12(1):84. doi: 10.1186/s40635-024-00671-2.

Reference Type: BACKGROUND

PMID: 39331249 (View on PubMed)

Other Identifiers

2019-A02814-53

Identifier Type: OTHER

Identifier Source: secondary_id

APHP191033

Identifier Type: -

Identifier Source: org_study_id