Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients

NCT ID: NCT06513299

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 4300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-24
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

VT1 - low tidal volume

Patients mechanically ventilated with tidal volume between 6.0 and 8.0 ml/kg PBW, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice.

low tidal volume

Intervention Type: DEVICE

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.

VT2 - high tidal volume

Patients mechanically ventilated with tidal volume between 8.0 and 10.0 ml/kg PBW, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice.

high tidal volume

Intervention Type: DEVICE

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.

∆P1 - low driving pressure

Patients mechanically ventilated with driving pressure between 7.0 and 12.0 cmH2O, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice.

low driving pressure

Intervention Type: DEVICE

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.

∆P2 - high driving pressure

Patients mechanically ventilated with driving pressure between 12.0 and 18.0 cmH2O, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice.

high driving pressure

Intervention Type: DEVICE

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.

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

Sponsor Role: collaborator

University of Bari Aldo Moro

OTHER

Sponsor Role: collaborator

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mario Negri Institute for Pharmacological Research IRCCS

Ranica, BG, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

avengARDS

Identifier Type: -

Identifier Source: org_study_id