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

May 1, 2017 updated by: Paolo Pelosi, University of Genova

Physiological Research on Variable Pressure Support Ventilation in Patients With Acute 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • Intensive Care Medicine Unit - IRCCS San Martino - IST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Noisy-PSV 1
different levels of variable pressure support
Other: Noisy-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%.
Other: Noisy-PSV 2
different levels of variable pressure support
Other: Noisy-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 45 minutes of mechanical ventilation with each level of variable pressure support

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 9 minutes, up to 45 minutes, of mechanical ventilation in each level of variable pressure support
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
after 45 minutes of mechanical ventilation with each level of variable pressure support
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.
after 45 minutes of mechanical ventilation with each level of variable pressure support

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Genova

Investigators

  • Study Director: Paolo Pelosi, Professor, University of Genoa, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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