Variable Pressure Support Trial

Acute Lung Injury Clinical Trial

— ViPS  

Official title:

International Multicenter Randomized Controlled Open Trial on Variable vs. Non-Variable Pressure Support for Weaning From Mechanical Ventilation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01769053
• Other study ID #: EK235082012
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Adult Respiratory Distress Syndrome
• at Least 24 h of Controlled Mechanical Ventilation
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Variable Ventilation

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care, Dresden University of Technology	Dresden

Sponsors (12)

Lead Sponsor

Collaborator

Technische Universität Dresden

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Fachkrankenhaus Coswig GmbH, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Copa D’Or, Rio de Janeiro, Brazil, Hospital Sírio-Libânes, São Paulo, Brazil, Hospital Universitari Sant Joan de Reus, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, Medical University of Vienna, St Thomas' Hospital, London, University Hospital, Montpellier, University of Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning time	Weaning time defined as time from randomization to successful extubation.	From time of randomization until the time of successful extubation, estimated to be up to 30 days

External Links

•   Institution's and project's website