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NCT Number: NCT06513299

Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypoxemia ARDS Acute Lung Injury Hypoxia Lung Diseases Lung Injury Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mario Negri Institute for Pharmacological Research IRCCS

Ranica, BG, 24020, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • arterial oxygen tension (PaO2) to inspiratory oxygen fraction (FiO2) ratio P/F ≤ 300 mmHg
  • hypoxemia developed within one week of a known clinical insult
  • hypoxemia not fully explained by cardiac failure or fluid overload*

Exclusion criteria

  • pregnancy
  • expected duration of mechanical ventilation < 48h
  • severe or moderate COPD
  • chronic liver disease
  • acute brain injury
  • patient admitted for palliative sedation
  • tumor with metastases
  • prior cardiac arrest
  • New York Heart Association Class IV
  • acute coronary syndrome
  • patients transferred from other ICUs
  • patients transferred to the ICU from the Emergency Department after a duration exceeding 24 hours in the Emergency Department
  • patients on Pressure Support Ventilation and/or patients in whom end-inspiratory plateau pressure was not measured

Treatment and study plan

Low tidal volume

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.

High tidal volume

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.

low driving pressure

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.

high driving pressure

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.

Primary outcomes

  1. ICU all-cause mortality

    Time frame: 14 days from assignment to intervention arm

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

Secondary outcomes

  1. Ventilator-free days

    Time frame: 14 days from assignment to intervention arm

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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Other

Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri
  • University of Bari Aldo Moro

Registry information

Official study title

Assessing the Effectiveness of Low Tidal Volume and Low Driving Pressure in Mechanically Ventilated Severe Hypoxemic Patients: a Multicenter Emulated Target Trial

Acronym: avengARDS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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