NCT06655805

Registry for Automated Mechanical VEntilation in Adults

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Hamilton Medical AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Respiratory Insufficiency Requiring Mechanical Ventilation

Interventions

Type	Name	Description
DEVICE	Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen	No intervention is intended by the nature of this observational study.

Timeline

• Start date: 2024-09-23
• Primary completion: 2030-06-30
• Completion: 2030-12-31
• First posted: 2024-10-23
• Last updated: 2026-01-16

Locations

4 sites across 1 country: Switzerland