Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients

Active, not recruitingOBSERVATIONAL
Enrollment

4,300

Participants

Timeline

Start Date

December 24, 2024

Primary Completion Date

August 1, 2025

Study Completion Date

December 31, 2025

Conditions
HypoxemiaArds
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.

Trial Locations (1)

24020

Mario Negri Institute for Pharmacological Research IRCCS, Ranica

All Listed Sponsors
collaborator

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

collaborator

University of Bari Aldo Moro

OTHER

lead

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

OTHER

NCT06513299 - Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients | Biotech Hunter | Biotech Hunter