Clinical trial NCT04827927: The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power
Official title: The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power - a Multicenter Crossover Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Mechanical Power
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Reinier de Graaf Groep
name: Dijklander Ziekenhuis
name: University of Zurich
First posted: 2021-04-01
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. The current study will directly compare the amount of MP in invasively ventilated critically ill patients by calculating MP breath-by-breath, using the various equations proposed in the literature.

Detailed 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 (ΔP) 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.

Eligibility criteria: Inclusion Criteria:

* Admitted to one of the participating ICUs;
* Receiving invasive ventilation through a standard endotracheal (i.e., oral) tube;
* Expected to be ventilated \> 24 hours; and
* Ventilation is applied by a ventilator that can provide INTELLiVENT-ASV and conventional ventilation.

Exclusion Criteria:

* Age under 18 years;
* No written informed consent;
* Morbidly obese; and
* Any contra-indication for use of INTELLiVENT-ASV

Primary outcomes:
measure: The amount of MP delivered with each form of invasive ventilation
timeFrame: 3 hours per ventilation mode
Secondary outcomes:
measure: Duration of ventilation
timeFrame: first 28 days after start of ventilation
measure: ICU-length and hospital of stay
timeFrame: first 28 days after start of ventilation
measure: 28 day-mortality
timeFrame: first 28 days after start of ventilation
measure: Tidal volume
timeFrame: 3 hours per ventilation mode
measure: Respiratory rate
timeFrame: 3 hours per ventilation mode
measure: Pmax
timeFrame: 3 hours per ventilation mode
measure: Driving pressure
timeFrame: 3 hours per ventilation mode
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
Study officials:
affiliation: Department of Intensive Care, Amsterdam University Medical Centre - location AMC
name: Marcus J Schultz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Intensive Care, Amsterdam University Medical Centre - location AMC
name: Frederique Paulus, PhD
role: STUDY_DIRECTOR
affiliation: Department of Intensive Care, Amsterdam University Medical Centre - location AMC
name: Laura A Buiteman-Kruizinga, RN, BSc
role: STUDY_DIRECTOR
References: