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

Primary Purpose

Acute Lung Injury (ALI), Acute Distress Respiratory Syndrome (ARDS)

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Noisy-PSV 1
Noisy-PSV 2
Sponsored by
University of Genova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury (ALI) focused on measuring ALI, ARDS, Noisy pressure support ventilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intensive Care Medicine Unit - IRCCS San Martino - IST

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Noisy-PSV 1

Noisy-PSV 2

Arm Description

different levels of variable pressure support

different levels of variable pressure support

Outcomes

Primary Outcome Measures

Effect on arterial oxygenation in each setting of variability
The investigators perform an arterial blood gas and oxygenation is evaluated with PaO2/FiO2 ratio

Secondary Outcome Measures

work of breathing
work of breathing will be recorded as pressure-time product (PTP) measured on the esophageal pressure curve.
effects on hemodynamic
the investigator will record blood pressure and cardiac output
effect on arterial carbon dioxide
The investigators perform an arterial blood gas and arterial carbon dioxide is evaluated with PaCO2.

Full Information

First Posted
August 29, 2012
Last Updated
May 1, 2017
Sponsor
University of Genova
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1. Study Identification

Unique Protocol Identification Number
NCT01683669
Brief Title
Effect of Variable PSV in Acute Lung Injury: Part I and Part II
Official Title
Physiological Research on Variable Pressure Support Ventilation in Patients With Acute Acute Lung Injury: Part I and Part II
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Genova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury (ALI), Acute Distress Respiratory Syndrome (ARDS)
Keywords
ALI, ARDS, Noisy pressure support ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noisy-PSV 1
Arm Type
Other
Arm Description
different levels of variable pressure support
Arm Title
Noisy-PSV 2
Arm Type
Other
Arm Description
different levels of variable pressure support
Intervention Type
Other
Intervention Name(s)
Noisy-PSV 1
Intervention Description
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%.
Intervention Type
Other
Intervention Name(s)
Noisy-PSV 2
Intervention Description
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 Outcome Measure Information:
Title
Effect on arterial oxygenation in each setting of variability
Description
The investigators perform an arterial blood gas and oxygenation is evaluated with PaO2/FiO2 ratio
Time Frame
after 45 minutes of mechanical ventilation with each level of variable pressure support
Secondary Outcome Measure Information:
Title
work of breathing
Description
work of breathing will be recorded as pressure-time product (PTP) measured on the esophageal pressure curve.
Time Frame
every 9 minutes, up to 45 minutes, of mechanical ventilation in each level of variable pressure support
Title
effects on hemodynamic
Description
the investigator will record blood pressure and cardiac output
Time Frame
after 45 minutes of mechanical ventilation with each level of variable pressure support
Title
effect on arterial carbon dioxide
Description
The investigators perform an arterial blood gas and arterial carbon dioxide is evaluated with PaCO2.
Time Frame
after 45 minutes of mechanical ventilation with each level of variable pressure support

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, Professor
Organizational Affiliation
University of Genoa, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Intensive Care Medicine Unit - IRCCS San Martino - IST
City
Genoa
ZIP/Postal Code
16132
Country
Italy

12. IPD Sharing Statement

Citations:
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16675618
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Effect of Variable PSV in Acute Lung Injury: Part I and Part II

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