Lowering PEEP: Weaning From High PEEP Setting

NCT ID: NCT04429399

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-21
• Study Completion Date: 2022-01-01

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.

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.

Conditions

Mechanical Ventilation Complication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

High positive end-expiratory pressure Ventilation

patient ventilated fixing high level of positive end expiratory pressure

Group Type: OTHER

decrease the positive end expiratory pressure (PEEP)

Intervention Type: OTHER

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

mechanical features assessment

Intervention Type: OTHER

evaluation of the mechanical features of respiratory system

shunt assessment

Intervention Type: OTHER

evaluation of the pulmonary shunt during two different ventilation setting

Low positive end-expiratory pressure Ventilation

patient ventilated fixing low level of positive end expiratory pressure

Group Type: OTHER

mechanical features assessment

Intervention Type: OTHER

evaluation of the mechanical features of respiratory system

shunt assessment

Intervention Type: OTHER

evaluation of the pulmonary shunt during two different ventilation setting

Interventions

decrease the positive end expiratory pressure (PEEP)

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

Intervention Type: OTHER

mechanical features assessment

evaluation of the mechanical features of respiratory system

Intervention Type: OTHER

shunt assessment

evaluation of the pulmonary shunt during two different ventilation setting

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bari

OTHER

Sponsor Role: lead

Responsible Party

Salvatore Grasso

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliero Universitaria Policlinico

Bari, , Italy

Countries

Italy

Other Identifiers

6011

Identifier Type: -

Identifier Source: org_study_id