Acute Lung InjuryViPSNCT01769053
Variable Pressure Support Trial
A study testing Variable Ventilation in people with Acute Lung Injury and Adult Respiratory Distress Syndrome, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Adult Respiratory Distress Syndrome, at Least 24 h of Controlled Mechanical Ventilation
- What is being tested?
- Variable Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Existing tracheotomy at ICU admission
- Expected survival < 72 hours
- Home mechanical ventilation or on chronic oxygen therapy
- Suspected pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care, Dresden University of Technology
Dresden, 01307
About this study
Official title: International Multicenter Randomized Controlled Open Trial on Variable vs. Non-Variable Pressure Support for Weaning From Mechanical Ventilation
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.
- Conditions
- Acute Lung Injury, Adult Respiratory Distress Syndrome, at Least 24 h of Controlled Mechanical Ventilation
- Being tested
- Variable Ventilation
- Keywords
- Acute Lung Injury, Adult Respiratory Distress Syndrome, Interactive Ventilatory Support, Positive-Pressure Respiration, Ventilator-Induced Lung Injury
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable VentilationOther
| Study group | Role | What they receive |
|---|---|---|
| Variable Ventilation | Active comparator | Patients are ventilated with variable pressure support mode. Receives: Other: Variable Ventilation |
| Conventional (non-variable) Ventilation | No intervention | Patients are ventilated with non-variable(conventional) pressure support ventilation mode. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning time
Weaning time defined as time from randomization to successful extubation.
Measured: From time of randomization until the time of successful extubation, estimated to be up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Rate of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- 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 Sirio-Libanes, Hospital Copa D'Or, Rio de Janeiro, Brazil, Hospital Universitari Sant Joan de Reus, University of Kiel, Fachkrankenhaus Coswig GmbH
- Responsible party
- Sponsor
- Investigators
- Marcelo Gama de Abreu, Principal investigator, Dresden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769053
- Sponsor's protocol ID
- EK235082012
- Acronym
- ViPS
- Status last verified
- Jul 2018
- First submitted
- 18 Dec 2012
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24176188
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Randomized Controlled Open Trial on Variable vs. Non-Variable Pressure Support for Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01769053
- Acronym / sponsor ID
- ViPS / EK235082012
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Rate of recruitment
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- 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 Sirio-Libanes, Hospital Copa D'Or, Rio de Janeiro, Brazil, Hospital Universitari Sant Joan de Reus, University of Kiel, Fachkrankenhaus Coswig GmbH
- Study start
- Jan 2013
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Variable Ventilation | Active comparator | Other: Variable VentilationPatients are ventilated with variable pressure support mode. |
| Conventional (non-variable) Ventilation | No intervention | –Patients are ventilated with non-variable(conventional) pressure support ventilation mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variable Ventilation | Other | Variable Ventilation |
Primary outcome
Weaning time
Time frame: From time of randomization until the time of successful extubation, estimated to be up to 30 days
Weaning time defined as time from randomization to successful extubation.
Results and safety
The study was stopped early (reason given: Rate of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 24176188Kiss 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.
- Institution's and project's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Gama de Abreu principal investigator
Dresden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable Ventilation in people with Acute Lung Injury and Adult Respiratory Distress Syndrome, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Rate of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning time (time frame: From time of randomization until the time of successful extubation, estimated to be up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.