Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients

Summary

The present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury (VILI)?"; (b) "if protection from VILI is better achieved by targeting the driving pressure instead of the tidal volume, what is the optimal target for the driving pressure?". Solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of VILI and avoid unnecessary risks associated to protective ventilatory settings.

Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre, to investigate the effect of low tidal volumes (6.0 to 8.0 ml/kg PBW vs 8.0 to 10.0 ml/kg PBW) and low driving pressures (7.0-12.0 cmH2O vs 12.0-18.0 cmH2O), respectively. Data will be used to obtain the dose-response curve of lower VT and lower ∆P in mechanically ventilated patients with acute severe hypoxemia.

Conditions

• Hypoxemia
• Ards

Interventions

DEVICE

low tidal volume

Patients ventilated with assist/control modes of mechanical ventilation with tidal volume between 6.0 ml/kg PBW and 8.0 ml/kg PBW with PPLAT ≤ 30 cmH2O, until weaning criteria are met: P/F ratio \> 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 \< 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg.

DEVICE

high tidal volume

Patients ventilated with assist/control modes of mechanical ventilation with tidal volume between 8.0 ml/Kg PBW and 10.0 ml/kg PBW with PPLAT ≤ 30 cmH2O, until weaning criteria are met: P/F ratio \> 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 \< 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg.

DEVICE

low driving pressure

Patients ventilated with assist/control modes of mechanical ventilation with driving pressure between 7.0 cmH2O and 12.0 cmH2O with VT ≤ 10 ml/kg PBW, until weaning criteria are met: P/F ratio \> 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 \< 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg.

DEVICE

high driving pressure

Patients ventilated with assist/control modes of mechanical ventilation with driving pressure between 12.0 cmH2O and 18.0 cmH2O with VT ≤ 10 ml/kg PBW, until weaning criteria are met: P/F ratio \> 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 \< 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg.

Sponsors & Collaborators

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• University of Bari Aldo Moro

  collaborator OTHER

• Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-24

Primary Completion

2025-08-01

Completion

2025-12-31

Countries

• Italy

Study Locations