NCT01769053

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

5 years

First QC Date

December 18, 2012

Last Update Submit

July 25, 2018

Conditions

Acute Lung InjuryAdult Respiratory Distress Syndromeat Least 24 h of Controlled Mechanical Ventilation

Keywords

Acute Lung InjuryAdult Respiratory Distress SyndromeInteractive Ventilatory SupportPositive-Pressure RespirationVentilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Variable Ventilation

ACTIVE COMPARATOR

Patients are ventilated with variable pressure support mode.

Other: Variable Ventilation

Conventional (non-variable) Ventilation

NO INTERVENTION

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

Interventions

Variable VentilationOTHER
Variable Ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care, Dresden University of Technology

Dresden, 01307, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24176188DERIVED

Related Links

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress SyndromeVentilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Marcelo Gama de Abreu

    Dresden University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2012

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

DE(1)