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Completed

NCT Number: NCT04429399

Lowering PEEP: Weaning From High PEEP Setting

The perfusion of the deeply different areas coexisting in ARDS lung generates two type of venus-admixure : true shunt and shunt effect. Briefly, true shunt and shunt effect are related to non-aerated and poorly-ventilated lung areas perfusion respectively. Practically, it is not possible to quantify the true shunt and the shunt-effect directly, but we can measure the "total-shunt", i.e. the sum of two kind of venus-admixured. As it is known from classical physiology, the effects of FiO2 variations on PaO2 are deeply different depending on the type of venous admixures. In the case of a patient with virtually only true shunt, any FiO2 variation will not modify the PaO2. On the other hand, in a patient with virtually only a shunt effect, increasing the FiO2 the PaO2 will progressively increase. Indeed, ventilating a patient presenting only a shunt effect (without true shunt) with pure oxygen will generate a "normal" P/F ratio. In patients ventilated with high PEEP levels it is difficult to predict based on the P/F ratio the relative amount of true shunt and shunt effect. However, patients presenting a significant shunt effect when ventilated with higher PEEP level would likely have "unstable" poorly aerated lung areas that need PEEP to remain opened. In those patients, a PEEP-weaning protocol based on the P/F ratio could induce significant alveolar de-recruitment and clinical deterioration. On the contrary, patients with less shunt effect would be likely less prone to alveolar de-recruitment and would benefice from PEEP decrease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Policlinico

Bari, 70124, Italy

About this study

the investigators set up a study to test the hypothesis that patients presenting a significant shunt effect when ventilated with higher PEEP levels could be prone to significant alveolar de-recruitment at the PEEP weaning attempt. To do so, the investigator has to measure the total shunt at higher PEEP level in patients ready to be weaned from the PEEP (according to the Mercat protocol), at three FiO2 levels (i.e. 0,3, 0,6 and 1). The shunt effect is quantified as the difference in total shunt between FiO2 0,3 and .The hypothesis of this study is that the shunt effect could predict alveolar de-recruitment when weaning PEEP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age major than 18
  • 1-2 days since the beginning of mechanical ventilation
  • Moderate or severe ARDS

Exclusion criteria

  • Patients with a story of chronic obstructive pulmonary disease (COPD)
  • Patients with asthma
  • Patients with neurological disease
  • Patients with heart disease
  • Patients with cardiopulmonary.

Treatment and study plan

decrease the positive end expiratory pressure (PEEP)

Other

decrease the PEEP going from high (according to ExPress Trial) to low level

mechanical features assessment

Other

evaluation of the mechanical features of respiratory system

shunt assessment

Other

evaluation of the pulmonary shunt during two different ventilation setting

Primary outcomes

  1. de-recruitment

    Time frame: decreasing PEEP from high to low levelthrough study completion, an average of 2 years

    the shunt effect cold predict the lung de-recruitment volume

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

Effects of Positive End Expiratory Pressure (PEEP) Decrease in Patient With Acute Respiratory Distress Syndrome (ARDS) Ventilated According to High PEEP Strategy (ExPress Trial).

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 12, 2020
Registry last updated
Jan 21, 2022

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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