Variable Pressure Support Trial

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01769053

Acronym

ViPS

Enrollment

130

Registered

2013-01-16

Start date

2013-01-31

Completion date

2018-01-31

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERVariable Ventilation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Weaning time	From time of randomization until the time of successful extubation, estimated to be up to 30 days	Weaning time defined as time from randomization to successful extubation.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026