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

NCT ID: NCT04827927

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2023-07-01

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.

Conditions

Mechanical Ventilation; Mechanical Power

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INTELLiVENT-ASV

Use of INTELLiVENT-ASV during 3 hours with 30 minutes wash-out time before.

Group Type: EXPERIMENTAL

Procedure: INTELLiVENT-ASV

Intervention Type: PROCEDURE

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.

Conventional Ventilation

Use of conventional ventilation during 3 hours with 30 minutes wash-out time before.

Group Type: ACTIVE_COMPARATOR

Procedure: Conventional ventilation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reinier de Graaf Groep

OTHER

Sponsor Role: collaborator

Dijklander Ziekenhuis

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Marcus J. Schultz

Prof. Dr. Marcus J. Schultz

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcus J Schultz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care, Amsterdam University Medical Centre - location AMC

Frederique Paulus, PhD

Role: STUDY_DIRECTOR

Department of Intensive Care, Amsterdam University Medical Centre - location AMC

Laura A Buiteman-Kruizinga, RN, BSc

Role: STUDY_DIRECTOR

Department of Intensive Care, Amsterdam University Medical Centre - location AMC

Locations

Academic Medical Center

Amsterdam, North Holland, Netherlands

Reinier de Graaf Gasthuis

Delft, , Netherlands

Dijklander Ziekenhuis

Hoorn, , Netherlands

Countries

Netherlands

References

Buiteman-Kruizinga LA, Serpa Neto A, Botta M, List SS, de Boer BH, van Velzen P, Buhler PK, Wendel Garcia PD, Schultz MJ, van der Heiden PLJ, Paulus F; INTELLiPOWER-investigators. Effect of automated versus conventional ventilation on mechanical power of ventilation-A randomized crossover clinical trial. PLoS One. 2024 Jul 30;19(7):e0307155. doi: 10.1371/journal.pone.0307155. eCollection 2024.

Reference Type: DERIVED

PMID: 39078857 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

INTELLiPOWER

Identifier Type: -

Identifier Source: org_study_id