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

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Mechanical Power
• Intervention / Treatment: Procedure: Procedure: INTELLiVENT-ASV; Procedure: Procedure: Conventional ventilation

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura A. Buiteman-Kruizinga, RN, BSc; Phone Number: +31152604040; Email: l.a.kruizinga@amsterdamumc.nl

Study Locations

• Netherlands
  • Delft, Netherlands
    • Reinier de Graaf Gasthuis
  • Hoorn, Netherlands
    • Dijklander ziekenhuis
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTELLiVENT-ASV; Use of INTELLiVENT-ASV during 3 hours with 30 minutes wash-out time before.	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.
Active Comparator: Conventional Ventilation; Use of conventional ventilation during 3 hours with 30 minutes wash-out time before.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: University of Zurich; Dijklander Ziekenhuis; Reinier de Graaf Groep
• Investigators: Principal Investigator: Marcus J Schultz, MD, PhD, Department of Intensive Care, Amsterdam University Medical Centre - location AMC; Study Director: Frederique Paulus, PhD, Department of Intensive Care, Amsterdam University Medical Centre - location AMC; Study Director: Laura A Buiteman-Kruizinga, RN, BSc, Department of Intensive Care, Amsterdam University Medical Centre - location AMC

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: INTELLiPOWER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No