Clinical trial NCT01769053: Variable Pressure Support Trial
Official title: International Multicenter Randomized Controlled Open Trial on Variable vs. Non-Variable Pressure Support for Weaning From Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Lung Injury
Adult Respiratory Distress Syndrome
at Least 24 h of Controlled Mechanical Ventilation
Keywords: Acute Lung Injury
Adult Respiratory Distress Syndrome
Interactive Ventilatory Support
Positive-Pressure Respiration
Ventilator-Induced Lung Injury
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: University Hospital, Montpellier
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: St Thomas' Hospital, London
name: Hospital Sírio-Libânes, São Paulo, Brazil
name: Hospital Copa D'Or, Rio de Janeiro, Brazil
name: Hospital Universitari Sant Joan de Reus
name: University of Kiel
name: Fachkrankenhaus Coswig GmbH
First posted: 2013-01-16
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Weaning time
timeFrame: From time of randomization until the time of successful extubation, estimated to be up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Anesthesiology and Intensive Care, Dresden University of Technology
Study officials:
affiliation: Dresden University
name: Marcelo Gama de Abreu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.