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Variable Pressure Support Trial (ViPS)

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ClinicalTrials.gov Identifier: NCT01769053
Recruitment Status : Recruiting
First Posted : January 16, 2013
Last Update Posted : August 25, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Acute Lung Injury Adult Respiratory Distress Syndrome at Least 24 h of Controlled Mechanical Ventilation Other: Variable Ventilation

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 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
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

Information from the National Library of Medicine

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

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
Technische Universität Dresden
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
Universitätsklinikum Kiel, Germany
Fachkrankenhaus Coswig, Germany
Principal Investigator: Marcelo Gama de Abreu Dresden University
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01769053     History of Changes
Other Study ID Numbers: EK235082012
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016

Keywords provided by Technische Universität Dresden:
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
Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries