Clinical trial NCT01683669: Effect of Variable PSV in Acute Lung Injury: Part I and Part II
Official title: Physiological Research on Variable Pressure Support Ventilation in Patients With Acute Acute Lung Injury: Part I and Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury (ALI)
Acute Distress Respiratory Syndrome (ARDS)
Keywords: ALI
ARDS
Noisy pressure support ventilation
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Noisy Pressure Support Ventilation (noisy-PSV) would lead to improved lung function, while preserving respiratory muscle unloading. Basically, noisy PSV differs from other assisted mechanical ventilation modes that may also increase the variability of the respiratory pattern (e.g. proportional assist ventilation) by the fact that the variability does not depend on changes in the patient's inspiratory efforts.

The aim of this study is to evaluate the optimal variability for noisy PSV in patients with ALI based on its effects on respiratory mechanics, breathing comfort, gas exchange, and hemodynamics. The investigators hypothesize that noise in pressure support leads to variations in VT that are able to improve lung function and that physiologic variables respond differently to the degree of variability in pressure support


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Intubated/tracheostomized patients in assisted mechanical ventilation
* PaO2/FiO2 100-300, with PEEP ≥ than 5 cmH2O.

Exclusion Criteria:

* Pregnancy
* History of chronic lung disease (COPD)
* Presence of thoracic drainage

Primary outcomes:
measure: Effect on arterial oxygenation in each setting of variability
timeFrame: after 45 minutes of mechanical ventilation with each level of variable pressure support
Secondary outcomes:
measure: work of breathing
timeFrame: every 9 minutes, up to 45 minutes, of mechanical ventilation in each level of variable pressure support
measure: effects on hemodynamic
timeFrame: after 45 minutes of mechanical ventilation with each level of variable pressure support
measure: effect on arterial carbon dioxide
timeFrame: after 45 minutes of mechanical ventilation with each level of variable pressure support
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Intensive Care Medicine Unit - IRCCS San Martino - IST
Study officials:
affiliation: University of Genoa, Italy
name: Paolo Pelosi, Professor
role: STUDY_DIRECTOR
References:
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