Effect of Automated Closed-Loop Ventilation Versus Conventional Ventilation on Duration and Quality of Ventilation

NCT04593810 | Completed DMC

• 1 other identifier: ACTiVE
• Study Type: interventional
• Target: 1,201
• Locations: 2 countries
• Sites: 10

Brief Summary

INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of mechanical ventilation available on commercial ventilators. Evidence for clinical benefit of INTELLiVENT-ASV in comparison to non-automated ventilation is lacking. The ACTiVE study is an international, multicenter, randomized controlled trial in invasively ventilated ICU patients with the objective to compare INTELLiVENT-ASV to conventional ventilation. We hypothesise that INTELLiVENT-ASV shortens the duration of ventilation. The secondary hypothesis is that INTELLiVENT-ASV improves the quality of breathing.

Conditions

Ventilator-free Days; Quality of Breathing

Keywords

Automated invasive ventilation; Closed-loop invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days and alive at day 28

  The number of days from day 1 to day 28 the patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours

  first 28 days after start of ventilation

Secondary Outcomes (9)

• Quality of breathing

  24 hours early after start of invasive ventilation.

• Duration of ventilation

  first 28 days after start of ventilation

• Length of stay

  first 90 days after start of ventilation

• Mortality

  first 90 days after start of ventilation

• Pulmonary complications

  daily until ICU discharge or day 28

Study Arms (2)

INTELLiVENT-ASV

EXPERIMENTAL

Use of INTELLIVENT-ASV after intubation and during all mechanical ventilation in the ICU.

Procedure: INTELLiVENT-ASV

Conventional ventilation

ACTIVE COMPARATOR

Use of conventional ventilation after intubation and during all mechanical ventilation in the ICU.

Procedure: CONVENTIONAL VENTILATION

Interventions

CONVENTIONAL VENTILATION PROCEDURE

Conventional ventilation consists of VCV or PCV and PSV, depending on patient's activity. None of the semi or fully automated modes of ventilation is allowed at any time.

Conventional ventilation

INTELLiVENT-ASV PROCEDURE

INTELLiVENT-ASV is activated as soon possible. The sensors for ETCO2 and SpO2 are connected and activated. Patient's gender and height are set on the ventilator and patient condition is chosen if applicable.

INTELLiVENT-ASV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• admission to one of the participating ICUs
• intubated and receiving invasive ventilation
• anticipated duration of ventilation of at least 24 hours

You may not qualify if:

• age below 18 years
• patients with suspected or confirmed pregnancy
• invasive ventilation \> 1 hour in the ICU
• invasive ventilation \> 6 hours directly preceding the current ICU admission
• participation in another interventional trial using similar endpoints
• after recent pneumectomy or lobectomy
• morbid obesity (body mass index \> 40 kg/m2)
• premorbid restrictive pulmonary disease
• unreliable pulse oximetry (secondary to carbon monoxide poisoning or sickle cell disease)
• any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis
• patients receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO)
• unavailability of INTELLiVENT-ASV (no ventilator available with this ventilation mode)
• previously randomized in this study
• no informed consent

Sponsors & Collaborators

• Prof. Dr. Marcus J. Schultz: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Reinier de Graaf Groep: collaborator
• Flevoziekenhuis: collaborator
• Leiden University Medical Center: collaborator
• Canisius-Wilhelmina Hospital: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Diakonessenhuis, Utrecht: collaborator
• Ospedale Policlinico San Martino: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (10)

Ospedale Policlinico San Martino

Genoa, Italy

Location

Policlinico San Matteo Fondazione IRCCS

Pavia, Italy

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Academic Medical Center, Intensive Care

Amsterdam, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Leiden UMC

Leiden, Netherlands

Location

Canisius-Wilhelmina Hospital

Nijmegen, Netherlands

Location

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

Location

Diakonessenhuis, Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

• Sinnige JS, Buiteman-Kruizinga LA, Horn J, Paulus F, Schultz MJ, Serpa Neto A; ACTiVE Investigators and the Protective Ventilation Network. Effect of Automated Closed-Loop Ventilation vs Protocolized Conventional Ventilation on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2026 Mar 10;335(10):874-884. doi: 10.1001/jama.2025.24384.

  PMID: 41361939 DERIVED

• Botta M, Tsonas AM, Sinnige JS, De Bie AJR, Bindels AJGH, Ball L, Battaglini D, Brunetti I, Buiteman-Kruizinga LA, van der Heiden PLJ, de Jonge E, Mojoli F, Robba C, Schoe A, Paulus F, Pelosi P, Neto AS, Horn J, Schultz MJ; ACTiVE collaborative group. Effect of Automated Closed-loop ventilation versus convenTional VEntilation on duration and quality of ventilation in critically ill patients (ACTiVE) - study protocol of a randomized clinical trial. Trials. 2022 Apr 23;23(1):348. doi: 10.1186/s13063-022-06286-w.

  PMID: 35461264 DERIVED

Study Officials

• Janneke Horn, MD, PhD

  Department of Intensive Care, Academic Medical Center

  PRINCIPAL INVESTIGATOR

• Frederique Paulus, PhD

  Department of Intensive Care, Academic Medical Center

  STUDY DIRECTOR

• Marcus J Schultz, MD,PhD

  Department of Intensive Care, Academic Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Marcus J. Schultz

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 20, 2020
• Study Start: October 19, 2020
• Primary Completion: July 16, 2025
• Study Completion: September 16, 2025
• Last Updated: March 11, 2026

Record last verified: 2025-01

Locations

NL (8); IT (2)