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CompletedNCT04429399Updated Jan 21, 2022

Lowering PEEP: Weaning From High PEEP Setting

An interventional study of decrease the positive end expiratory pressure (PEEP) and mechanical features assessment in Mechanical Ventilation Complication, sponsored by University of Bari. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by University of Bari · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Sep 2019, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Mechanical Ventilation Complication
03

In context

Lead sponsor

University of Bari is the lead sponsor of 75 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Other
    High positive end-expiratory pressure Ventilation

    patient ventilated fixing high level of positive end expiratory pressure

    Other: decrease the positive end expiratory pressure (PEEP) · Other: mechanical features assessment · Other: shunt assessment

  • Other
    Low positive end-expiratory pressure Ventilation

    patient ventilated fixing low level of positive end expiratory pressure

    Other: mechanical features assessment · Other: shunt assessment

Interventions

  • Otherdecrease the positive end expiratory pressure (PEEP)

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

  • Othermechanical features assessment

    evaluation of the mechanical features of respiratory system

  • Othershunt assessment

    evaluation of the pulmonary shunt during two different ventilation setting

06

What researchers measure

Primary outcomes

  1. de-recruitment

    the shunt effect cold predict the lung de-recruitment volume

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

07

Study locations

1 site
  • Azienda Ospedaliero Universitaria Policlinico
    Bari, 70124, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04429399
Lead sponsor
University of Bari
Responsible party
Salvatore Grasso (Associate Professor, University of Bari) — Principal investigator
First posted
Jun 12, 2020
Start date
Sep 21, 2019
Primary completion
Jun 21, 2021
Completion
Jan 1, 2022
Last update
Jan 21, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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