Variable Pressure Support Trial

Not Applicable

Terminated

• Conditions: Acute Lung Injury; at Least 24 h of Controlled Mechanical Ventilation; Adult Respiratory Distress Syndrome
• Interventions: Other: Variable Ventilation

• Registration Number: NCT01769053
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-18
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-16
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-25
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Variable Ventilation	Variable Ventilation	Patients are ventilated with variable pressure support mode.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care, Dresden University of Technology; 🇩🇪 Dresden, Germany