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

Not Applicable

Completed

• Conditions: Mechanical Ventilation; Mechanical Power

• Registration Number: NCT04827927
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-01
• Study Start: 2021-07-05
• Primary Completion: 2023-04-01
• Study Completion: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The amount of MP delivered with each form of invasive ventilation	3 hours per ventilation mode	The amount of MP delivered with INTELLiVENT-ASV and conventional ventilation

Secondary Outcome Measures

Name	Time	Method
Pmax	3 hours per ventilation mode	Maximum airway pressure in cmH2O
ICU-length and hospital of stay	first 28 days after start of ventilation	Length of stay in the intensive care unit and in the hospital
28 day-mortality	first 28 days after start of ventilation	Any death during ICU-, hospital-stay and within 28 days
Driving pressure	3 hours per ventilation mode	Difference between end-inspiratory pressure and total Positieve End Expiratory Pressure in cmH2O
Duration of ventilation	first 28 days after start of ventilation	Duration of ventilation in survivors
Tidal volume	3 hours per ventilation mode	Tidal volume in ml/kg
Respiratory rate	3 hours per ventilation mode	Respiratory rate per minute

Trial Locations

Locations (3)

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Dijklander Ziekenhuis; 🇳🇱 Hoorn, Netherlands