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

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

Interventions

PROCEDURE

INTELLiVENT-ASV

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.

PROCEDURE

CONVENTIONAL VENTILATION

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.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

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

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Reinier de Graaf Groep

  collaborator OTHER

• Flevoziekenhuis

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• Diakonessenhuis, Utrecht

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Prof. Dr. Marcus J. Schultz

  lead OTHER

Principal Investigators

• Janneke Horn, MD, PhD · Department of Intensive Care, Academic Medical Center

• Frederique Paulus, PhD · Department of Intensive Care, Academic Medical Center

• Marcus J Schultz, MD,PhD · Department of Intensive Care, Academic Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-19

Primary Completion

2025-07-16

Completion

2025-09-16

Countries

• Italy
• Netherlands

Study Locations