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Clinical Trials in France / NCT06817629
Starting soon Observational

Effects of Ventilation With Tidal Volume Adjusted on Driving Pressure on Ventilation/Perfusion Ratios and Hemodynamics in ARDS

NCT06817629 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-03-03
Last updated
2025-02-10

Condition(s) studied

ARDS

Investigational drug(s) / intervention(s)

Effects of ventilation with tidal volume adjusted on driving pressure on ventilation/perfusion ratios and hemodynamics in ARDS

Effects of ventilation with tidal volume adjusted on driving pressure on ventilation/perfusion ratios and hemodynamics in ARDS: To ventilated patients with ARDS with an objective of driving pressure than a tidal volume set on predicted body weight

Study summary

The driving pressure (DP) is defined as the pressure above the end-expiratory pressure (PEEP) required to distend the respiratory system by the tidal volume (Vt). It is calculated as follows: DP = Plateau pressure - PEEP. It is also equal to the ratio between the tidal volume and the compliance of the respiratory system (Crs): DP = Vt/Crs. Crs is correlated with end-expiratory lung volume, i.e., the lung volume available to receive the tidal volume. DP allows adaptation of the Vt to the available lung volume when the lungs are diseased, rather than to a fraction of lung size when they are healthy, as occurs when tidal volume is adjusted in mL/kg of predicted body weight (PBW). DP is therefore a better reflection of the deformation applied by the tidal volume and the risk of overdistension. It is an important prognostic indicator in acute respiratory distress syndrome (ARDS), with a risk of excess mortality when DP exceeds 14 cm H2O. Conversely, an excessively low DP, suggesting a low tidal volume in relation to the available lung volume, may theoretically also be accompanied by deleterious effects: de-recruitment, atelectrauma, the need to increase respiratory rate, the need for significant sedation, or even curarization. DP and Vt can influence hemodynamics, as overdistension is associated with an increase in dead space and the occurrence of acute cor pulmonale. On the other hand, de-recruitment due to low tidal volume can lead to hypoxic vasoconstriction with an increase in right ventricular afterload.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * ARDS moderate to severe according to the Berlin criteria * Patient receiving continuous sedation and curarization * Free and informed consent from the patient or family member Exclusion Criteria: * Pregnancy * Adult patient subject to a legal protection measure (tutor, curator, etc.) * Patients with a pacemaker, automatic implantable cardioverter defibrillator, * Contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery) * Undrained pneumothorax, bronchopleural fistula * Hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR Créteil France

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06817629 on ClinicalTrials.gov ↗ ← All trials in France