Variable Pressure Support Trial (ViPS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Lung Injury; Adult Respiratory Distress Syndrome; at Least 24 h of Controlled Mechanical Ventilation
• Intervention / Treatment: Other: Variable Ventilation

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Department of Anesthesiology and Intensive Care, Dresden University of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Medical University of Vienna; University Hospital, Montpellier; University of Kiel; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); St Thomas' Hospital, London; 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; Hospital Universitari Sant Joan de Reus; Hospital Sírio-Libânes, São Paulo, Brazil; Hospital Copa D'Or, Rio de Janeiro, Brazil; Fachkrankenhaus Coswig GmbH
• Investigators: Principal Investigator: Marcelo Gama de Abreu, Dresden University

Publications and helpful links

General Publications

• Kiss T, Guldner A, Bluth T, Uhlig C, Spieth PM, Markstaller K, Ullrich R, Jaber S, Santos JA, Mancebo J, Camporota L, Beale R, Schettino G, Saddy F, Vallverdu I, Wiedemann B, Koch T, Schultz MJ, Pelosi P, de Abreu MG. Rationale and study design of ViPS - variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial. Trials. 2013 Oct 31;14:363. doi: 10.1186/1745-6215-14-363.

Helpful Links

• Institution's and project's website

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: January 14, 2013
• First Posted (Estimate): January 16, 2013

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Ventilator-Induced Lung Injury; Positive-Pressure Respiration; Acute Lung Injury; Adult Respiratory Distress Syndrome; Interactive Ventilatory Support
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: EK235082012