Registry for Automated Mechanical VEntilation in Adults

Recruiting

• Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation

• Registration Number: NCT06655805
• Lead Sponsor: Hamilton Medical AG

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-23
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Primary Completion: 2030-06-30
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:	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.
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:	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.

Trial Locations

Locations (1)

Kantonsspital Chur; 🇨🇭 Chur, Switerzland, Switzerland