Variable Pressure Support Trial (ViPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Technische Universität Dresden
Sponsor:
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):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01769053
First received: December 18, 2012
Last updated: February 7, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
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 by Technische Universität Dresden

Additional 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
Study First Received: December 18, 2012
Last Updated: February 7, 2013
Health Authority: Germany: Ethics Commission

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:
Syndrome
Respiratory Distress Syndrome, Newborn
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 29, 2014