Clinical trial NCT04184674: Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome
Official title: Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome
Mechanical ventilation
Transpulmonary pressure
Right ventricle failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Right ventricle failure
timeFrame: Three days
Secondary outcomes:
measure: Airways pressure
timeFrame: Three days
measure: Oesophageal pressure
timeFrame: Three days
measure: Transpulmonary pressure calculation
timeFrame: Three days
measure: Vaso-Active Inotrope Score (VIS)
timeFrame: Three days
measure: Duration of treatment with vasoactive or inotropic drugs
timeFrame: 3 months after hospitalization in Intensive Care Unit
measure: Pediatric logistic organ dysfunction score
timeFrame: Three days
measure: Sepsis-related Organ Function Assessement score
timeFrame: Three days
measure: Invasive and non invasive ventilation free days
timeFrame: 3 months after hospitalization in Intensive Care Unit
measure: Lung and Chest Wall compliance
timeFrame: Three days
measure: Length of hospitalization
timeFrame: 3 months after hospitalization in Intensive Care Unit
measure: Mortality at 28 days
timeFrame: 28 days
measure: Mortality in Intensive Care Unit
timeFrame: 3 months after hospitalization in Intensive Care Unit
measure: Eletrical impedance tomography
timeFrame: 3 days
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Meryl Vedrenne-Cloquet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte Fauroux, MD, PhD
role: STUDY_DIRECTOR
References: