Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients

N/AActive Not RecruitingNCT06513299

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva4,300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,300

Conditions

Hypoxemia Ards

Interventions

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.

high tidal volumeDEVICE

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.

low driving pressureDEVICE

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.

high driving pressureDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: all the following conditions present continuously for 24 hours commencing within 36 hours of ICU admission, while the patient is undergoing invasive mechanical ventilation in either flow or pressure- regulated assist/controlled modes: 1. arterial oxygen tension (PaO2) to inspiratory oxygen fraction (FiO2) ratio P/F ≤ 300 mmHg 2. hypoxemia developed within one week of a known clinical insult 3. hypoxemia not fully explained by cardiac failure or fluid overload\* Exclusion Criteria: 1. pregnancy 2. expected duration of mechanical ventilation \< 48h 3. severe or moderate COPD 4. chronic liver disease 5. acute brain injury 6. patient admitted for palliative sedation 7. tumor with metastases 8. prior cardiac arrest 9. New York Heart Association Class IV 10. acute coronary syndrome 11. patients transferred from other ICUs 12. patients transferred to the ICU from the Emergency Department after a duration exceeding 24 hours in the Emergency Department 13. patients on Pressure Support Ventilation and/or patients in whom end-inspiratory plateau pressure was not measured

Outcomes

Primary Outcomes

ICU all-cause mortality

All patients will be classified as either alive if "alive at ICU discharge" or dead if "dead at ICU discharge"

Time frame: 14 days from assignment to intervention arm

Secondary Outcomes

Ventilator-free days

Number of ventilator-free days (VFDs) during the 14 days in ICU