Variable Pressure Support Trial

NCT ID: NCT01769053

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Variable Ventilation

Patients are ventilated with variable pressure support mode.

Group Type ACTIVE_COMPARATOR

Variable Ventilation

Intervention Type OTHER

Conventional (non-variable) Ventilation

Patients are ventilated with non-variable(conventional) pressure support ventilation mode.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Variable Ventilation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role collaborator

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

OTHER

Sponsor Role collaborator

St Thomas' Hospital, London

OTHER

Sponsor Role collaborator

Hospital Sírio-Libânes, São Paulo, Brazil

UNKNOWN

Sponsor Role collaborator

Hospital Copa D'Or, Rio de Janeiro, Brazil

UNKNOWN

Sponsor Role collaborator

Hospital Universitari Sant Joan de Reus

OTHER

Sponsor Role collaborator

University of Kiel

OTHER

Sponsor Role collaborator

Fachkrankenhaus Coswig GmbH

INDUSTRY

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcelo Gama de Abreu

Role: PRINCIPAL_INVESTIGATOR

Dresden University

Locations

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Department of Anesthesiology and Intensive Care, Dresden University of Technology

Dresden, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24176188 (View on PubMed)

Related Links

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http://www.peg-dresden.de

Institution's and project's website

Other Identifiers

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EK235082012

Identifier Type: -

Identifier Source: org_study_id

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