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Completed

NCT Number: NCT04184674

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Ambroise Paré, Boulogne-Billancourt, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumotachograph

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

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

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

Other

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

Primary outcomes

  1. Right ventricle failure

    Time frame: Three days

    Right ventricle failure is defined, by ultrasound, as a composite criteria associating :

    • end-diastolic right ventricle/left ventricle area ratio > 0.6 and/or Acute Cor Pulmonale (assocation with a septal dyskinesia),
    • and/or a tricuspid annular plane systolic excursion < 1,6 cm (adults), z-score < -2 (children),
    • and/or a doppler-derived tricuspid lateral annular systolic velocity (S wave) < 10 cm/s,
    • and/or a two-dimensional Fractional Area Change (defined as end-diastolic area - end-systolic area)/end-diastolic area x100) < 35%,
    • and/or a peak right ventricle free wall 2D strain < -30% (adults), z-score < 2 (children).

Secondary outcomes

  1. Airways pressure

    Time frame: Three days

    Airways pressure (Paw) will be measured in cmH2O thanks to a pneumotachograph connected to the ventilator.

  2. Oesophageal pressure

    Time frame: Three days

    Esophageal pressure (Pes) will be measured in cmH2O thanks to an oesophageal balloon catheter introduced in the mid-esophagus of the patient and connected to a manometer.

  3. Transpulmonary pressure calculation

    Time frame: Three days

    Measurements will be performed at different moments during the respiratory cycle: after an inspiratory pause to evaluate the tele-inspiratory transpulmonary pressure (PL-insp), and after an expiratory pause to evaluate the tele-expiratory transpulmonary pressure (PL-PEP ). The PL-insp will be calculated using the ratio between the elastance of the chest wall (Ecw) and of the respiratory system (Ers) thanks to this formula PL = Paw - Paw x (Ecw/Ers). The PL-exp will be calculated using the ratio between Paw et Pes (PL = Paw - Pes). Transpulmonary pressure will be expressed in cmH2O.

  4. Vaso-Active Inotrope Score (VIS)

    Time frame: Three days

    Correlation between transpulmonary pressure and morbidity. Vaso-Active Inotrope Score is a hemodynamic score taking into account the cumulative doses of inotropic or vassopressive drugs. It is obtained thanks this calculation : VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 10 x milrinone dose (µg/kg/min) + 10000 x vasopressin dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min). Its value ranges from zero, which is associated to a better outcome, to the maximum cumulative dose without any limit.

  5. Duration of treatment with vasoactive or inotropic drugs

    Time frame: 3 months after hospitalization in Intensive Care Unit

    Number of days under vaso-active or inotropic drugs

  6. Pediatric logistic organ dysfunction score

    Time frame: Three days

    Pediatric logistic organ dysfunction score is a specific pediatric multiple organ dysfunction score that includes 10 variables corresponding to 5 organ dysfunctions. Values extend from 0 (best outcome) to 33 (worst outcome).

  7. Sepsis-related Organ Function Assessement score

    Time frame: Three days

    Sepsis-related Organ Function Assessement score is a multiple organ dysfunction score that includes several variables corresponding to 6 organ dysfunctions. Values extend from 0 (best outcome) to 24 (worst outcome).

  8. Invasive and non invasive ventilation free days

    Time frame: 3 months after hospitalization in Intensive Care Unit

    Number of invasive and non invasive ventilation free days

  9. Lung and Chest Wall compliance

    Time frame: Three days

    Lung and chest wall compliances (in mL/cmH2O) will be calculated thanks to the respective ratios tidal volume/(PL-insp - PL-PEP) and tidal volume/(Pes insp - Pes-PEP).

  10. Length of hospitalization

    Time frame: 3 months after hospitalization in Intensive Care Unit

    Length of hospitalization in Intensive Care Unit and in hospital in days.

  11. Mortality at 28 days

    Time frame: 28 days

    Death in Intensive Care Unit and at 28 days of hospitalization.

  12. Mortality in Intensive Care Unit

    Time frame: 3 months after hospitalization in Intensive Care Unit

    Death in Intensive Care Unit.

  13. Eletrical impedance tomography

    Time frame: 3 days

    Electrical impedance tomography will be monitored only in children. Several methods will be used and compared, based on e.g. pixel information of lung aeration, to assess end-expiratory lung volume (ELLV, in mL) and the distribution of ventilation

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: VD-SDRA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2019
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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