Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients (avengARDS)

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Status: Active, not recruiting

Conditions: Ards; Hypoxemia

Treatments: Device: high tidal volume; Device: low driving pressure; Device: high driving pressure; Device: low tidal volume

Study type: Observational

Funder types: Other

Identifiers

NCT06513299

avengARDS

Details and patient eligibility

About

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.

Enrollment: 4,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,300 participants in 4 patient groups

VT1 - low tidal volume

Description:

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.

Treatment:

Device: low tidal volume

VT2 - high tidal volume

Description:

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.

Treatment:

Device: high tidal volume

∆P1 - low driving pressure

Description:

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.

Treatment:

Device: low driving pressure

∆P2 - high driving pressure

Description:

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.

Treatment:

Device: high driving pressure