Lowering PEEP: Weaning From High PEEP Setting

NCT04429399 | Completed DMC

• 1 other identifier: 6011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• de-recruitment

  the shunt effect cold predict the lung de-recruitment volume

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

Study Arms (2)

High positive end-expiratory pressure Ventilation

OTHER

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

Low positive end-expiratory pressure Ventilation

OTHER

patient ventilated fixing low level of positive end expiratory pressure

Other: mechanical features assessment; Other: shunt assessment

Interventions

decrease the positive end expiratory pressure (PEEP) OTHER

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

High positive end-expiratory pressure Ventilation

mechanical features assessment OTHER

evaluation of the mechanical features of respiratory system

High positive end-expiratory pressure Ventilation; Low positive end-expiratory pressure Ventilation

shunt assessment OTHER

evaluation of the pulmonary shunt during two different ventilation setting

High positive end-expiratory pressure Ventilation; Low positive end-expiratory pressure Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico

Bari, 70124, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 12, 2020
• Study Start: September 21, 2019
• Primary Completion: June 21, 2021
• Study Completion: January 1, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

IT (1)