Completed

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

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What is being tested

Noisy-PSV 1

+ Noisy-PSV 2

Other
Who is being recruted

Lung Diseases+3

+ Respiration Disorders

+ Respiratory Tract Diseases

From 18 to 80 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorUniversity of Genova
Last updated: May 3, 2017
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Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01683669
Principal SponsorUniversity of Genova
Last updated: May 3, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesRespiration DisordersRespiratory Tract DiseasesLung InjuryRespiratory Distress SyndromeAcute Lung Injury

Criteria

3 inclusion criteria required to participate
Age >= 18 years
Intubated/tracheostomized patients in assisted mechanical ventilation
PaO2/FiO2 100-300, with PEEP >= than 5 cmH2O
3 exclusion criteria prevent from participating
History of chronic lung disease (COPD)
Pregnancy
Presence of thoracic drainage

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

different levels of variable pressure support

Group II

different levels of variable pressure support

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Intensive Care Medicine Unit - IRCCS San Martino - IST

Genoa, ItalyOpen Intensive Care Medicine Unit - IRCCS San Martino - IST in Google Maps
CompletedOne Study Center