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

Mechanical Ventilation Clinical Trial

— INTELLiPOWER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827927
• Other study ID #: INTELLiPOWER
• Status: Completed
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Power
• Mechanical Ventilation

Intervention

Procedure:
• Procedure: 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.
• Procedure: 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.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Dijklander Ziekenhuis	Hoorn

Sponsors (4)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of MP delivered with each form of invasive ventilation	The amount of MP delivered with INTELLiVENT-ASV and conventional ventilation	3 hours per ventilation mode
Secondary	Duration of ventilation	Duration of ventilation in survivors	first 28 days after start of ventilation
Secondary	ICU-length and hospital of stay	Length of stay in the intensive care unit and in the hospital	first 28 days after start of ventilation
Secondary	28 day-mortality	Any death during ICU-, hospital-stay and within 28 days	first 28 days after start of ventilation
Secondary	Tidal volume	Tidal volume in ml/kg	3 hours per ventilation mode
Secondary	Respiratory rate	Respiratory rate per minute	3 hours per ventilation mode
Secondary	Pmax	Maximum airway pressure in cmH2O	3 hours per ventilation mode
Secondary	Driving pressure	Difference between end-inspiratory pressure and total Positieve End Expiratory Pressure in cmH2O	3 hours per ventilation mode