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

NCT04184674 | Completed

• 2 other identifiers: APHP1910332019-A02814-53
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; Mechanical ventilation; Transpulmonary pressure; Right ventricle failure

Outcome Measures

Primary Outcomes (1)

• Right ventricle failure

  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).

  Three days

Secondary Outcomes (13)

• Airways pressure

  Three days

• Oesophageal pressure

  Three days

• Transpulmonary pressure calculation

  Three days

• Vaso-Active Inotrope Score (VIS)

  Three days

• Duration of treatment with vasoactive or inotropic drugs

  3 months after hospitalization in Intensive Care Unit

Study Arms (1)

Acute Respiratory Distress Syndrome

OTHER

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

Other: Pneumotachograph; Other: Esophageal catheter; Other: Transthoracic and / or transesophageal cardiac ultrasound; Other: Electrical impedance tomography (EIT) for pediatric patients

Interventions

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).

Acute Respiratory Distress Syndrome

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).

Acute Respiratory Distress Syndrome

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).

Acute Respiratory Distress Syndrome

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.

Acute Respiratory Distress Syndrome

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 39331249 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Meryl Vedrenne-Cloquet, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Brigitte Fauroux, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: June 11, 2020
• Primary Completion: June 11, 2022
• Study Completion: June 11, 2022
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

FR (2)