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
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
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
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:
PubMed Identifier
16675618
Citation
Falk DJ, Deruisseau KC, Van Gammeren DL, Deering MA, Kavazis AN, Powers SK. Mechanical ventilation promotes redox status alterations in the diaphragm. J Appl Physiol (1985). 2006 Oct;101(4):1017-24. doi: 10.1152/japplphysiol.00104.2006. Epub 2006 May 4.
Results Reference
background
PubMed Identifier
10806138
Citation
Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med. 2000 May;161(5):1450-8. doi: 10.1164/ajrccm.161.5.9902018.
Results Reference
background
PubMed Identifier
17495742
Citation
Seymour CW, Frazer M, Reilly PM, Fuchs BD. Airway pressure release and biphasic intermittent positive airway pressure ventilation: are they ready for prime time? J Trauma. 2007 May;62(5):1298-308; discussion 1308-9. doi: 10.1097/TA.0b013e31803c562f.
Results Reference
background
PubMed Identifier
15891341
Citation
Neumann P, Wrigge H, Zinserling J, Hinz J, Maripuu E, Andersson LG, Putensen C, Hedenstierna G. Spontaneous breathing affects the spatial ventilation and perfusion distribution during mechanical ventilatory support. Crit Care Med. 2005 May;33(5):1090-5. doi: 10.1097/01.ccm.0000163226.34868.0a.
Results Reference
background
PubMed Identifier
16625116
Citation
Henzler D, Pelosi P, Bensberg R, Dembinski R, Quintel M, Pielen V, Rossaint R, Kuhlen R. Effects of partial ventilatory support modalities on respiratory function in severe hypoxemic lung injury. Crit Care Med. 2006 Jun;34(6):1738-45. doi: 10.1097/01.CCM.0000218809.49883.54.
Results Reference
background
PubMed Identifier
9603516
Citation
Suki B, Alencar AM, Sujeer MK, Lutchen KR, Collins JJ, Andrade JS Jr, Ingenito EP, Zapperi S, Stanley HE. Life-support system benefits from noise. Nature. 1998 May 14;393(6681):127-8. doi: 10.1038/30130. No abstract available.
Results Reference
background
PubMed Identifier
12851212
Citation
Arold SP, Suki B, Alencar AM, Lutchen KR, Ingenito EP. Variable ventilation induces endogenous surfactant release in normal guinea pigs. Am J Physiol Lung Cell Mol Physiol. 2003 Aug;285(2):L370-5. doi: 10.1152/ajplung.00036.2003.
Results Reference
background
PubMed Identifier
11850336
Citation
Boker A, Graham MR, Walley KR, McManus BM, Girling LG, Walker E, Lefevre GR, Mutch WA. Improved arterial oxygenation with biologically variable or fractal ventilation using low tidal volumes in a porcine model of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2002 Feb 15;165(4):456-62. doi: 10.1164/ajrccm.165.4.2108006.
Results Reference
background
PubMed Identifier
11401900
Citation
Mutch WA, Lefevre GR, Cheang MS. Biologic variability in mechanical ventilation in a canine oleic acid lung injury model. Am J Respir Crit Care Med. 2001 Jun;163(7):1756-7. doi: 10.1164/ajrccm.163.7.16372c. No abstract available.
Results Reference
background
PubMed Identifier
8912782
Citation
Lefevre GR, Kowalski SE, Girling LG, Thiessen DB, Mutch WA. Improved arterial oxygenation after oleic acid lung injury in the pig using a computer-controlled mechanical ventilator. Am J Respir Crit Care Med. 1996 Nov;154(5):1567-72. doi: 10.1164/ajrccm.154.5.8912782.
Results Reference
background
PubMed Identifier
10921579
Citation
Mutch WA, Harms S, Lefevre GR, Graham MR, Girling LG, Kowalski SE. Biologically variable ventilation increases arterial oxygenation over that seen with positive end-expiratory pressure alone in a porcine model of acute respiratory distress syndrome. Crit Care Med. 2000 Jul;28(7):2457-64. doi: 10.1097/00003246-200007000-00045.
Results Reference
background
PubMed Identifier
16809999
Citation
McMullen MC, Girling LG, Graham MR, Mutch WA. Biologically variable ventilation improves oxygenation and respiratory mechanics during one-lung ventilation. Anesthesiology. 2006 Jul;105(1):91-7. doi: 10.1097/00000542-200607000-00017.
Results Reference
background
PubMed Identifier
18431269
Citation
Gama de Abreu M, Spieth PM, Pelosi P, Carvalho AR, Walter C, Schreiber-Ferstl A, Aikele P, Neykova B, Hubler M, Koch T. Noisy pressure support ventilation: a pilot study on a new assisted ventilation mode in experimental lung injury. Crit Care Med. 2008 Mar;36(3):818-27. doi: 10.1097/01.CCM.0000299736.55039.3A.
Results Reference
background
PubMed Identifier
19194161
Citation
Spieth PM, Carvalho AR, Guldner A, Pelosi P, Kirichuk O, Koch T, de Abreu MG. Effects of different levels of pressure support variability in experimental lung injury. Anesthesiology. 2009 Feb;110(2):342-50. doi: 10.1097/ALN.0b013e318194d06e.
Results Reference
background
PubMed Identifier
15269312
Citation
Brower RG, Lanken PN, MacIntyre N, Matthay MA, Morris A, Ancukiewicz M, Schoenfeld D, Thompson BT; National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004 Jul 22;351(4):327-36. doi: 10.1056/NEJMoa032193.
Results Reference
background
PubMed Identifier
34744766
Citation
Ball L, Sutherasan Y, Fiorito M, Dall'Orto A, Maiello L, Vargas M, Robba C, Brunetti I, D'Antini D, Raimondo P, Huhle R, Schultz MJ, Rocco PRM, Gama de Abreu M, Pelosi P. Effects of Different Levels of Variability and Pressure Support Ventilation on Lung Function in Patients With Mild-Moderate Acute Respiratory Distress Syndrome. Front Physiol. 2021 Oct 22;12:725738. doi: 10.3389/fphys.2021.725738. eCollection 2021.
Results Reference
derived
Learn more about this trial
Effect of Variable PSV in Acute Lung Injury: Part I and Part II
We'll reach out to this number within 24 hrs