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The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power

The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power - a Multicenter Crossover Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04827927
Acronym
INTELLiPOWER
Enrollment
96
Registered
2021-04-01
Start date
2021-07-05
Completion date
2023-07-01
Last updated
2023-08-24

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

Conditions

Mechanical Power, Mechanical Ventilation

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.

Interventions

PROCEDUREProcedure: INTELLiVENT-ASV

With INTELLiVENT-ASV, the patient's conditions, 'ARDS', 'Chronic Hypercapnia' or 'Traumatic Brain Injury' can be chosen, if applicable. The controllers for minute volume, PEEP and FiO2 are all activated, and the target shifts for etCO2 and SpO2 are adjusted, if necessary.

PROCEDUREProcedure: Conventional ventilation

With conventional ventilation, the same etCO2 and SpO2 levels are targeted as with INTELLiVENT-ASV, but here the caregiver is fully responsible for choosing the settings.

Sponsors

Reinier de Graaf Groep
CollaboratorOTHER
Dijklander Ziekenhuis
CollaboratorOTHER
University of Zurich
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The amount of MP delivered with each form of invasive ventilation3 hours per ventilation modeThe amount of MP delivered with INTELLiVENT-ASV and conventional ventilation

Secondary

MeasureTime frameDescription
ICU-length and hospital of stayfirst 28 days after start of ventilationLength of stay in the intensive care unit and in the hospital
28 day-mortalityfirst 28 days after start of ventilationAny death during ICU-, hospital-stay and within 28 days
Tidal volume3 hours per ventilation modeTidal volume in ml/kg
Duration of ventilationfirst 28 days after start of ventilationDuration of ventilation in survivors
Pmax3 hours per ventilation modeMaximum airway pressure in cmH2O
Driving pressure3 hours per ventilation modeDifference between end-inspiratory pressure and total Positieve End Expiratory Pressure in cmH2O
Respiratory rate3 hours per ventilation modeRespiratory rate per minute

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026