Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way of ventilating patients with Acute Respiratory Distress Syndrome (ARDS), a serious condition that affects the lungs and can lead to severe breathing difficulties. The trial aims to find out if using a method called "driving pressure-guided tidal volume ventilation" can improve survival rates compared to the traditional approach. In simpler terms, this new method tailors the amount of air delivered to patients based on their specific lung condition rather than just their body size. Previous research suggests that this personalized approach might reduce lung injury caused by mechanical ventilation.

To participate in this trial, patients must be over 18 years old and require invasive mechanical ventilation due to ARDS, which is defined by specific criteria related to their lung function. They should also be enrolled within 72 hours of meeting these criteria. However, individuals who are pregnant, have certain serious lung conditions, or are not expected to survive for at least 24 hours will not be eligible. Participants can expect to receive careful monitoring and tailored ventilation to help improve their breathing and overall health. The trial is not yet recruiting, but it represents an important step toward potentially better treatments for ARDS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 years
• • Invasive mechanical ventilation
• * Criteria for ARDS according to Berlin definition:
• • Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules;
• • PaO2/FiO2 of 300 or less measured with a PEEP of at least 5 cm H2O
• • Respiratory failure not fully explained by cardiac failure or fluid overload These criteria must be observed for less than 72h
• • Affiliation to the social security system
• • Written consent obtained from the patients (from a support person, family member or a close relative if the patient is not able to expressing and sign consent) or inclusion without initial consent in case of emergency, if the patient is not able to express his/her consent and in the absence of support person, family member or a close relative
• Exclusion Criteria:
• • Known pregnancy
• • Lung transplantation
• • Evident significant decrease in chest wall compliance (e.g., abdominal compartment syndrome)
• • Moribund patient not expected to survive 24 hours
• • Presence of an advanced directive to withhold life-sustaining treatment or decision to withhold life-sustaining treatment
• • Chronic respiratory disease requiring home oxygen therapy or ventilation
• • ECMO before inclusion
• • Pneumothorax
• • Enrollment in an interventional ARDS trial with direct impact on VT
• • Subject deprived of freedom, subject under a legal protective measure (guardianship/curatorship)