Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2021-05-01
2022-06-15
Brief Summary
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Detailed Description
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Intubated patients fulfilling ARDS criteria, undergoing assisted ventilation as per clinical decision and exhibiting intense inspiratory effort (occlusion pressure equal or greater than 13 cmH2O) will be enrolled.
Patients will be placed in a 30°-45° head up position during all study phases. According to our institution protocol, pressure support setting will be selected by the attending physician to target a predefined tidal volume range of 6-8 mL/kg of predicted body weight (PBW) (female PBW \[kg\] = 45.5 + 0.91 \[cm of height - 152.4\]; male PBW \[kg\] = 50 + 0.91 \[cm of height - 152.4\]).The lowest pressure support level allowed will be 7 cmH2O, even if Vt \<8 ml/Kg PBW is not achieved.
In each patient, four different ventilator settings will be applied in a random order. Each step will last 45 minutes.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Low PEEP and full inspiratory synchronization
PEEP = 5 cmH2O + clinically selected pressure support (PSVclin)
Mechanical Ventilation
Respiratory support through mechanical ventilator
High PEEP and full inspiratory synchronization
PEEP = 15 cmH2O + clinically selected pressure support (PSVclin)
Mechanical Ventilation
Respiratory support through mechanical ventilator
Low PEEP and inspiratory desynchronization
PEEP = 5 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O)
Mechanical Ventilation
Respiratory support through mechanical ventilator
High PEEP and inspiratory desynchronization
PEEP = 15 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O)
Mechanical Ventilation
Respiratory support through mechanical ventilator
Interventions
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Mechanical Ventilation
Respiratory support through mechanical ventilator
Eligibility Criteria
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Inclusion Criteria
* (b) assisted ventilation, as prescribed by the attending physician
* (c) intense inspiratory effort, defined as a negative deflection in the airway pressure equal or greater than 13 cmH2O in the first breath recorded during an end-expiratory occlusion
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Giuseppe Bello, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico A. Gemelli IRCCS
Massimo Antonelli, MD
Role: STUDY_DIRECTOR
Fondazione Policlinico A. Gemelli IRCCS
Locations
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Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, , Italy
Countries
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References
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Bello G, Giammatteo V, Bisanti A, Delle Cese L, Rosa T, Menga LS, Montini L, Michi T, Spinazzola G, De Pascale G, Pennisi MA, Ribeiro De Santis Santiago R, Berra L, Antonelli M, Grieco DL. High vs Low PEEP in Patients With ARDS Exhibiting Intense Inspiratory Effort During Assisted Ventilation: A Randomized Crossover Trial. Chest. 2024 Jun;165(6):1392-1405. doi: 10.1016/j.chest.2024.01.040. Epub 2024 Jan 29.
Other Identifiers
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EARDS
Identifier Type: -
Identifier Source: org_study_id
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