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NCT Number: NCT06655805

Registry for Automated Mechanical VEntilation in Adults

The aim of the here proposed study is to assess safety, performance and provide real world evidence (RWE) of the Hamilton Medical AG automated mechanical ventilation software packages in consecutive critically ill patients admitted to the intensive care unit.

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Key information

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Surgical ICU, Sankt Gallen, Canton of St. Gallen, Switzerland

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About this study

The harmful effect of invasive mechanical ventilation can be prevented by intensive training of ICU physicians, respiratory therapists, and ICU nurses on the one hand, and by improvement of the technology installed in ventilators on the other hand. Advanced mechanical ventilation modes use new technologies to assist physiology, optimize gas exchange and minimize ventilator induced lung injury. Modes such as proportional assist ventilation and neuronally adjusted ventilatory assist deliver assisted ventilation proportional to the patient's effort, improving ventilator patient synchrony. The Adaptive Support Ventilation (ASV) mode automatically adjust tidal volume and respiratory rate based on patient's respiratory mechanics to protect from mechanical ventilator induced lung injury, hence deliver safe mechanical ventilation. The implementation of advanced closed-loop systems automates medical reasoning and has potential to improve patient ventilator interactions, the time spent on mechanical ventilation, staff workload and potentially outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years. Any patient in need of HFNO, NIV and IMV at some time during its ICU stay.

Exclusion criteria

Expected to be weaned from HFNO, NIV within 2 hours. Expected to be weaned and extubated from IMV without subsequent need of HFNO or NIV support within 2 hours.

Expected to be transferred to another non-participating ICU within 2 hours. Moribund subject: death expected within 2 hours.

Treatment and study plan

Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen

Device

No intervention is intended by the nature of this observational study.

Primary outcomes

  1. The primary safety endpoint is determinate by the percentage of breaths outside of the optimal and the acceptable zone during the observation period, based on the following ventilation parameters if available:

    Time frame: Day 0 - Day 7

    Tidal volume (VT), maximum pressure (Pmax), oxygen saturation measured by pulse oximetry (SpO2), end-tidal partial pressure of carbon dioxide (PetCO2), Respiratory rate (RR) for spontaneous breathing subjects, Pmax-PEEP for passive ARDS subjects, driving pressure, mechanical power. The optimal and sub-optimal ranges are defined by current recommendations for different clinical conditions including normal lungs, brain injury, ARDS, and chronic hypercapnia.

  2. The efficiency endpoint is determinate by the percentage of breath inside of the optimal zone during the observation period based on the following ventilation parameters if available:

    Time frame: Day 0 - Day 7

    tidal volume (VT), maximum pressure (Pmax), oxygen saturation measured by pulse oximetry (SpO2), end-tidal partial pressure of carbon dioxide (PetCO2), Respiratory rate (RR) for spontaneous breathing subjects, Pmax-PEEP for passive ARDS subjects, driving pressure, mechanical power. The optimal and sub-optimal ranges are defined by current recommendations for different clinical conditions including normal lungs, brain injury, ARDS, and chronic hypercapnia.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominik Novotni, MD

CONTACT

[email protected]

+41586101514

Marco V Maggiorini, MD

CONTACT

[email protected]

+41586101514

Sponsors and collaborators

Lead sponsor

Hamilton Medical AG

Industry

Registry information

Acronym: RAVE

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Oct 23, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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