We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683669
First Posted: September 12, 2012
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova
  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: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiological Research on Variable Pressure Support Ventilation in Patients With Acute Acute Lung Injury: Part I and Part II

Resource links provided by NLM:


Further study details as provided by Paolo Pelosi, 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 ]
    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 ]
    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 ]
    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 ]
    The investigators perform an arterial blood gas and arterial carbon dioxide is evaluated with PaCO2.


Enrollment: 20
Study Start Date: August 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683669


Locations
Italy
Intensive Care Medicine Unit - IRCCS San Martino - IST
Genoa, Italy, 16132
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
First Submitted: August 29, 2012
First Posted: September 12, 2012
Last Update Posted: May 3, 2017
Last Verified: May 2017

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

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