The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Mechanical Power
- Mechanical Ventilation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Rationale: Mechanical ventilation can cause ventilator-induced lung injury (VILI). Lung protective ventilation, consisting of a low tidal volume (VT), a low plateau pressure (Pplateau) and a low driving pressure (?P) improves survival and shortens duration of ventilation in patients with acute respi...
Rationale: Mechanical ventilation can cause ventilator-induced lung injury (VILI). Lung protective ventilation, consisting of a low tidal volume (VT), a low plateau pressure (Pplateau) and a low driving pressure (?P) improves survival and shortens duration of ventilation in patients with acute respiratory distress syndrome (ARDS). Lung protective ventilation may also benefit critically ill patients with respiratory failure not caused by ARDS. 'Mechanical Power of ventilation' (MP), the amount of energy per time transferred from the ventilator to the respiratory system, is a summary variable that includes all the components that play a role in VILI. With fully-automated closed-loop ventilation, these components are no longer set by the operator, but under control of the algorithms in the ventilator. Objective: To compare MP under INTELLiVENT-adaptive support ventilation (ASV), a fully-automated closed-loop ventilation, with MP under conventional ventilation. Hypothesis: INTELLiVENT-ASV compared to conventional ventilation results in a lower MP. Study design: National, multicenter, crossover, randomized clinical trial. Study population: Invasively ventilated critically ill patients. Methods: The ventilator will be randomly switched between INTELLiVENT-ASV for 3 hours and conventional ventilation for 3 hours. The amount of MP is calculated using various equations proposed in the literature. Study endpoints: The primary endpoint is the amount of MP with each form of invasive ventilation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Differences in burden and risks of the two ventilation strategies compared in the current study are not expected. Both modes of ventilation are interchangeably used as part of standard care in the participating centers. No other interventions are performed. Neither the collection of demographic and outcome data, nor the capturing of ventilation characteristics causes harm to patients.
Tracking Information
- NCT #
- NCT04827927
- Collaborators
- Reinier de Graaf Groep
- Dijklander Ziekenhuis
- Investigators
- Principal Investigator: Marcus J Schultz, MD, PhD Department of Intensive Care, Amsterdam University Medical Centre - location AMC Study Director: Frederique Paulus, PhD Department of Intensive Care, Amsterdam University Medical Centre - location AMC