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NCT Number: NCT01683669

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

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

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Key information

Conditions

Acute Lung Injury (ALI) Acute Distress Respiratory Syndrome (ARDS) Acute Lung Injury Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Medicine Unit - IRCCS San Martino - IST

Genoa, 16132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noisy-PSV 1

Other

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%.

Noisy-PSV 2

Other

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.

Primary outcomes

  1. Effect on arterial oxygenation in each setting of variability

    Time frame: 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 outcomes

  1. work of breathing

    Time frame: 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.

  2. effects on hemodynamic

    Time frame: after 45 minutes of mechanical ventilation with each level of variable pressure support

    the investigator will record blood pressure and cardiac output

  3. effect on arterial carbon dioxide

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2012
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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