Variable Pressure Support Trial (ViPS)
Primary Purpose
Acute Lung Injury, Adult Respiratory Distress Syndrome, at Least 24 h of Controlled Mechanical Ventilation
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Variable Ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury focused on measuring Acute Lung Injury, Adult Respiratory Distress Syndrome, Interactive Ventilatory Support, Positive-Pressure Respiration, Ventilator-Induced Lung Injury
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Duration of controlled mechanical ventilation ≥ 24h
- Availability of a Infinity V500 ventilator (ready to use)
- Informed consent according to local regulations
- Temperature ≤ 39 °C
- Hemoglobin ≥ 6 g/dl
- PaO2/FIO2 ≥ 150 mmHg with positive end-expiratory pressure (PEEP) ≤16 cmH2O
- Ability to breath spontaneously
Exclusion Criteria:
- Participation in another interventional trial within the last four weeks before enrollment in this trial
- Peripheral neurological disease associated with impairment of the respiratory pump
- Muscular disease associated with impairment of the respiratory pump
- Instable thorax with paradoxical chest wall movement
- Planned surgery under general anesthesia within 72 hours
- Difficult airway/intubation
- Existing tracheotomy at ICU admission
- Expected survival < 72 hours
- Home mechanical ventilation or on chronic oxygen therapy
- Suspected pregnancy
Sites / Locations
- Department of Anesthesiology and Intensive Care, Dresden University of Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Variable Ventilation
Conventional (non-variable) Ventilation
Arm Description
Patients are ventilated with variable pressure support mode.
Patients are ventilated with non-variable(conventional) pressure support ventilation mode.
Outcomes
Primary Outcome Measures
Weaning time
Weaning time defined as time from randomization to successful extubation.
Secondary Outcome Measures
Full Information
NCT ID
NCT01769053
First Posted
December 18, 2012
Last Updated
July 25, 2018
Sponsor
Technische Universität Dresden
Collaborators
Medical University of Vienna, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Hospital, Montpellier, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, St Thomas' Hospital, London, Hospital Sírio-Libânes, São Paulo, Brazil, Hospital Copa D'Or, Rio de Janeiro, Brazil, Hospital Universitari Sant Joan de Reus, University of Kiel, Fachkrankenhaus Coswig GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01769053
Brief Title
Variable Pressure Support Trial
Acronym
ViPS
Official Title
International Multicenter Randomized Controlled Open Trial on Variable vs. Non-Variable Pressure Support for Weaning From Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Rate of recruitment
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Medical University of Vienna, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Hospital, Montpellier, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, St Thomas' Hospital, London, Hospital Sírio-Libânes, São Paulo, Brazil, Hospital Copa D'Or, Rio de Janeiro, Brazil, Hospital Universitari Sant Joan de Reus, University of Kiel, Fachkrankenhaus Coswig GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In 2008 a new ventilation strategy termed variable Pressure Support ventilation (PSV) was introduced, which is able to increase the variability of the respiratory pattern independent from the inspiratory effort. In experimental lung injury, variable PSV was found to improve gas exchange and decrease the inspiratory effort, while reducing alveolar edema and inflammatory infiltration compared to conventional(non-variable) PSV. Importantly, variable PSV reduced peak airway pressure and respiratory system elastance in a variability dependent manner.In addition, preliminary observations suggest that variable PSV can reduce the work of breathing and improve patient comfort, but it is not known whether this new ventilatory strategy is able to speed the weaning from mechanical ventilation.
Since variable PSV can reduce the mean pressure support, it may lead to a faster reduction of pressure support and, therefore, a shorter weaning period than conventional PSV.
The hypothesis of this study is that variable pressure support ventilation reduces the duration of mechanical ventilation to non-variable (conventional) pressure support ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Adult Respiratory Distress Syndrome, at Least 24 h of Controlled Mechanical Ventilation
Keywords
Acute Lung Injury, Adult Respiratory Distress Syndrome, Interactive Ventilatory Support, Positive-Pressure Respiration, Ventilator-Induced Lung Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Variable Ventilation
Arm Type
Active Comparator
Arm Description
Patients are ventilated with variable pressure support mode.
Arm Title
Conventional (non-variable) Ventilation
Arm Type
No Intervention
Arm Description
Patients are ventilated with non-variable(conventional) pressure support ventilation mode.
Intervention Type
Other
Intervention Name(s)
Variable Ventilation
Primary Outcome Measure Information:
Title
Weaning time
Description
Weaning time defined as time from randomization to successful extubation.
Time Frame
From time of randomization until the time of successful extubation, estimated to be up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Duration of controlled mechanical ventilation ≥ 24h
Availability of a Infinity V500 ventilator (ready to use)
Informed consent according to local regulations
Temperature ≤ 39 °C
Hemoglobin ≥ 6 g/dl
PaO2/FIO2 ≥ 150 mmHg with positive end-expiratory pressure (PEEP) ≤16 cmH2O
Ability to breath spontaneously
Exclusion Criteria:
Participation in another interventional trial within the last four weeks before enrollment in this trial
Peripheral neurological disease associated with impairment of the respiratory pump
Muscular disease associated with impairment of the respiratory pump
Instable thorax with paradoxical chest wall movement
Planned surgery under general anesthesia within 72 hours
Difficult airway/intubation
Existing tracheotomy at ICU admission
Expected survival < 72 hours
Home mechanical ventilation or on chronic oxygen therapy
Suspected pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Gama de Abreu
Organizational Affiliation
Dresden University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care, Dresden University of Technology
City
Dresden
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24176188
Citation
Kiss T, Guldner A, Bluth T, Uhlig C, Spieth PM, Markstaller K, Ullrich R, Jaber S, Santos JA, Mancebo J, Camporota L, Beale R, Schettino G, Saddy F, Vallverdu I, Wiedemann B, Koch T, Schultz MJ, Pelosi P, de Abreu MG. Rationale and study design of ViPS - variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial. Trials. 2013 Oct 31;14:363. doi: 10.1186/1745-6215-14-363.
Results Reference
derived
Links:
URL
http://www.peg-dresden.de
Description
Institution's and project's website
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Variable Pressure Support Trial
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