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

This study is currently recruiting participants.
Verified September 2012 by University of Genova
Sponsor:
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova
ClinicalTrials.gov Identifier:
NCT01683669
First received: August 29, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention
Acute Lung Injury (ALI)
Acute Distress Respiratory Syndrome (ARDS)
 Other: Noisy-PSV 1
Other: Noisy-PSV 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physiological Research on Variable Pressure Support Ventilation in Patients With Acute Acute Lung Injury: Part I and Part II

Further study details as provided by University of Genova:

Primary Outcome Measures:
  • Effect on arterial oxygenation in each setting of variability [ Time Frame: after 45 minutes of mechanical ventilation with each level of variable pressure support ] [ Designated as safety issue: Yes ]
    The investigators perform an arterial blood gas and oxygenation is evaluated with PaO2/FiO2 ratio


Secondary Outcome Measures:
  • work of breathing [ Time Frame: every 9 minutes, up to 45 minutes, of mechanical ventilation in each level of variable pressure support ] [ Designated as safety issue: Yes ]
    work of breathing will be recorded as pressure-time product (PTP) measured on the esophageal pressure curve.

  • effects on hemodynamic [ Time Frame: after 45 minutes of mechanical ventilation with each level of variable pressure support ] [ Designated as safety issue: Yes ]
    the investigator will record blood pressure and cardiac output

  • effect on arterial carbon dioxide [ Time Frame: after 45 minutes of mechanical ventilation with each level of variable pressure support ] [ Designated as safety issue: Yes ]
    The investigators perform an arterial blood gas and arterial carbon dioxide is evaluated with PaCO2.


Estimated Enrollment: 32
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683669

Contacts
Contact: Paolo Pelosi, Professor 010 5553136 ppelosi@hotmail.com

Locations
Italy
Intensive Care Medicine Unit - IRCCS San Martino - IST Recruiting
Genoa, Italy, 16132
Contact: Paolo Pelosi, Professor     +39 010 5553136     ppelosi@hotmail.com    
Principal Investigator: Paolo Pelosi, Chief of ICU            
Sub-Investigator: Maria Vargas, MD            
Sub-Investigator: Iole Brunetti, MD            
Principal Investigator: Marcelo Gama De Abreu, Professor            
Sponsors and Collaborators
University of Genova
Investigators
Study Director: Paolo Pelosi, Professor University of Genoa, Italy
  More Information

Publications:

Responsible Party: Paolo Pelosi, Full Professor - Chair of Anesthesiology and Intensive Care Medicine. Chief of Intensive Care Medicine, University of Genova
ClinicalTrials.gov Identifier: NCT01683669     History of Changes
Other Study ID Numbers: 91/12
Study First Received: August 29, 2012
Last Updated: September 7, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Genova:
ALI
ARDS
Noisy pressure support ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013