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

Not Applicable

Completed

• Conditions: Acute Lung Injury (ALI); Acute Distress Respiratory Syndrome (ARDS)
• Interventions: Other: Noisy-PSV 2; Other: Noisy-PSV 1

• Registration Number: NCT01683669
• Lead Sponsor: University of Genova

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Noisy-PSV 2	Noisy-PSV 2	different levels of variable pressure support
Noisy-PSV 1	Noisy-PSV 1	different levels of variable pressure support

Primary Outcome Measures

Name	Time	Method
Effect on arterial oxygenation in each setting of variability	after 45 minutes of mechanical ventilation with each level of variable pressure support	The investigators perform an arterial blood gas and oxygenation is evaluated with PaO2/FiO2 ratio

Secondary Outcome Measures

Name	Time	Method
effects on hemodynamic	after 45 minutes of mechanical ventilation with each level of variable pressure support	the investigator will record blood pressure and cardiac output
effect on arterial carbon dioxide	after 45 minutes of mechanical ventilation with each level of variable pressure support	The investigators perform an arterial blood gas and arterial carbon dioxide is evaluated with PaCO2.
work of breathing	every 9 minutes, up to 45 minutes, of mechanical ventilation in each level of variable pressure support	work of breathing will be recorded as pressure-time product (PTP) measured on the esophageal pressure curve.

Trial Locations

Locations (1)

Intensive Care Medicine Unit - IRCCS San Martino - IST; 🇮🇹 Genoa, Italy