Variable Pressure Support Trial (ViPS)
This study is currently recruiting participants.
Verified February 2013 by Dresden University of Technology
Sponsor:
Dresden University of Technology
Collaborators:
Medical University of Vienna
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital, Montpellier
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
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
Information provided by (Responsible Party):
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01769053
First received: December 18, 2012
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Lung Injury Adult Respiratory Distress Syndrome at Least 24 h of Controlled Mechanical Ventilation |
Other: Variable Ventilation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | International Multicenter Randomized Controlled Open Trial on Variable vs. Non-Variable Pressure Support for Weaning From Mechanical Ventilation |
Further study details as provided by Dresden University of Technology:
Primary Outcome Measures:
- Weaning time [ Time Frame: From time of randomization until the time of successful extubation, estimated to be up to 30 days ] [ Designated as safety issue: No ]Weaning time defined as time from randomization to successful extubation.
| Estimated Enrollment: | 228 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Variable Ventilation
Patients are ventilated with variable pressure support mode.
|
Other: Variable Ventilation |
|
No Intervention: Conventional (non-variable) Ventilation
Patients are ventilated with non-variable(conventional) pressure support ventilation mode.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769053
Locations
| Germany | |
| Department of Anesthesiology and Intensive Care, Dresden University of Technology | Recruiting |
| Dresden, Germany, 01307 | |
| Contact: Thomas Kiss thomas.kiss@uniklinikum-dresden.de | |
| Contact: Marcelo Gama de Abreu mgabreu@uniklinikum-dresden.de | |
| Principal Investigator: Marcelo Gama de Abreu | |
Sponsors and Collaborators
Dresden University of Technology
Medical University of Vienna
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital, Montpellier
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
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
Investigators
| Principal Investigator: | Marcelo Gama de Abreu | Dresden University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT01769053 History of Changes |
| Other Study ID Numbers: | EK235082012 |
| Study First Received: | December 18, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Dresden University of Technology:
|
Acute Lung Injury Adult Respiratory Distress Syndrome Interactive Ventilatory Support Positive-Pressure Respiration Ventilator-Induced Lung Injury |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013