Registry for Automated Mechanical Ventilation in Adults
Hamilton Medical AG · NCT06655805
This study tests a new automated breathing support system to see if it can help critically ill patients in the ICU breathe better and reduce lung damage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hamilton Medical AG (industry) |
| Locations | 4 sites (Sankt Gallen, Canton of St. Gallen and 3 other locations) |
| Trial ID | NCT06655805 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and performance of Hamilton Medical AG's automated mechanical ventilation software in critically ill patients requiring respiratory support in the intensive care unit. It focuses on collecting real-world evidence to assess how advanced ventilation modes can optimize patient outcomes and minimize lung injury. The study will involve patients who need non-invasive ventilation, invasive mechanical ventilation, or high-flow nasal oxygen during their ICU stay.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require respiratory support such as high-flow nasal oxygen, non-invasive ventilation, or invasive mechanical ventilation during their ICU stay.
Not a fit: Patients who are expected to be weaned from respiratory support within 2 hours or are moribund with an expected death within 2 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of mechanical ventilation for critically ill patients.
How similar studies have performed: Other studies have shown promise in using advanced mechanical ventilation technologies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sankt Gallen, Canton of St. Gallen and 3 other locations
- HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Surgical ICU — Sankt Gallen, Canton of St. Gallen, Switzerland (RECRUITING)
- Kantonsspital Chur — Chur, Kanton Graubünden, Switzerland (RECRUITING)
- HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Medical ICU — Sankt Gallen, St.Gallen, Switzerland (RECRUITING)
- Kantonsspital Winterthur, Zentrum für Intensivmedizin — Winterthur, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Francesca Porta, MD — Kantonsspital Chur, Chur, Switerzland 7000
- Study coordinator: Marco V Maggiorini, MD
- Email: mmaggiorini@hamilton-medical.com
- Phone: +41586101514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation, Real world data, Acute respiratory failure, Respiratory support, Invasive Mechanical Ventilation, Non Invasive Ventilation, High Flow Nasal Oxygen