Variable Pressure Support Trial (ViPS)
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| ClinicalTrials.gov Identifier: NCT01769053 |
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Recruitment Status :
Terminated
(Rate of recruitment)
First Posted : January 16, 2013
Last Update Posted : July 26, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Lung Injury Adult Respiratory Distress Syndrome at Least 24 h of Controlled Mechanical Ventilation | Other: Variable Ventilation | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | January 2018 |
| Actual Study Completion Date : | January 2018 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Variable Ventilation
Patients are ventilated with variable pressure support mode.
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Other: Variable Ventilation |
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No Intervention: Conventional (non-variable) Ventilation
Patients are ventilated with non-variable(conventional) pressure support ventilation mode.
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- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769053
| Germany | |
| Department of Anesthesiology and Intensive Care, Dresden University of Technology | |
| Dresden, Germany, 01307 | |
| Principal Investigator: | Marcelo Gama de Abreu | Dresden University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Technische Universität Dresden |
| ClinicalTrials.gov Identifier: | NCT01769053 |
| Other Study ID Numbers: |
EK235082012 |
| First Posted: | January 16, 2013 Key Record Dates |
| Last Update Posted: | July 26, 2018 |
| Last Verified: | July 2018 |
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Acute Lung Injury Adult Respiratory Distress Syndrome Interactive Ventilatory Support Positive-Pressure Respiration Ventilator-Induced Lung Injury |
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Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Injury Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |