Registry for Automated Mechanical VEntilation in Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHamilton Medical AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen
DeviceNo intervention is intended by the nature of this observational study.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: One cohort of consecutive patients1 intervention
Trial outcomes
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:
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.
Time frame
Day 0 - Day 72
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:
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.
Time frame
Day 0 - Day 7Sponsors and contacts
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Source ClinicalTrials.gov