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Effect of Variable PSV in Acute Lung Injury: Part I and Part II

Physiological Research on Variable Pressure Support Ventilation in Patients With Acute Acute Lung Injury: Part I and Part II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01683669
Enrollment
20
Registered
2012-09-12
Start date
2012-08-31
Completion date
2016-12-31
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Distress Respiratory Syndrome (ARDS), Acute Lung Injury (ALI)

Keywords

ALI, ARDS, Noisy pressure support ventilation

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

Interventions

OTHERNoisy-PSV 1

Noisy-PSV 1: different levels of variable pressure support (PS) will be randomized: a) PS variability equal to 0%, b) PS variability equal to 45%, c) PS variability equal to 90%.

OTHERNoisy-PSV 2

Noisy-PSV 2 : different levels of variable Pressure Support (PS) will be randomized: a) PS equal to Baseline and variability 0%; b) PS equal to Baseline and variability set in order achieve an increase or decrease of pressure of 5 cmH2O; c) PS equal to Baseline - 5 cmH2O and variability 0%; d) PS equal to Baseline - 5 cmH2O and set in order achieve an increase or decrease of pressure of 5 cmH2O.

Sponsors

University of Genova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect on arterial oxygenation in each setting of variabilityafter 45 minutes of mechanical ventilation with each level of variable pressure supportThe investigators perform an arterial blood gas and oxygenation is evaluated with PaO2/FiO2 ratio

Secondary

MeasureTime frameDescription
work of breathingevery 9 minutes, up to 45 minutes, of mechanical ventilation in each level of variable pressure supportwork of breathing will be recorded as pressure-time product (PTP) measured on the esophageal pressure curve.
effects on hemodynamicafter 45 minutes of mechanical ventilation with each level of variable pressure supportthe investigator will record blood pressure and cardiac output
effect on arterial carbon dioxideafter 45 minutes of mechanical ventilation with each level of variable pressure supportThe investigators perform an arterial blood gas and arterial carbon dioxide is evaluated with PaCO2.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026