Registry for Automated Mechanical VEntilation in Adults (RAVE)

January 15, 2026 updated by: Hamilton Medical AG
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Winterthur, Switzerland, 8400
        • Recruiting
        • Kantonsspital Winterthur, Zentrum für Intensivmedizin
        • Contact:
          • Philipp Bühler, MD
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Recruiting
        • HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Surgical ICU
        • Contact:
          • Urs Pietsch, MD
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Switzerland, 7000
        • Recruiting
        • Kantonsspital Chur
        • Contact:
    • St.Gallen
      • Sankt Gallen, St.Gallen, Switzerland, 9007
        • Recruiting
        • HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Medical ICU
        • Contact:
          • Gian-Reto Kleger, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients admitted to the intensive care unit while on IMV or in need of HFNO, NIV lung support due to acute respiratory failure, or protection of the airway due to a non-respiratory life-threatening condition.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
One cohort of consecutive patients
One cohort of consecutive patients admitted to the intensive care unit while on IMV or in need of HFNO, NIV lung support due to acute respiratory failure.
Device: Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen
No intervention is intended by the nature of this observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 - Day 7
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.
Day 0 - Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Medical AG

Investigators

  • Principal Investigator: Francesca Porta, MD, Kantonsspital Chur, Chur, Switerzland 7000

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM - RAVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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