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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen | Device | No intervention is intended by the nature of this observational study. |
|
| 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: | 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: | 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 |
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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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco V Maggiorini, MD | Contact | +41586101514 | mmaggiorini@hamilton-medical.com | |
| Dominik Novotni, MD | Contact | +41586101514 | dnovotni@hamilton-medical.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesca Porta, MD | Kantonsspital Chur, Chur, Switerzland 7000 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Surgical ICU | Recruiting | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26903337 | Background | Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. | |
| 26181219 |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Kantonsspital Chur | Recruiting | Chur | Kanton Graubünden | 7000 | Switzerland |
|
| HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Medical ICU | Recruiting | Sankt Gallen | St.Gallen | 9007 | Switzerland |
|
| Kantonsspital Winterthur, Zentrum für Intensivmedizin | Recruiting | Winterthur | 8400 | Switzerland |
|
| Background |
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| 34830691 | Background | Buiteman-Kruizinga LA, Mkadmi HE, Serpa Neto A, Kruizinga MD, Botta M, Schultz MJ, Paulus F, van der Heiden PLJ. Effect of INTELLiVENT-ASV versus Conventional Ventilation on Ventilation Intensity in Patients with COVID-19 ARDS-An Observational Study. J Clin Med. 2021 Nov 19;10(22):5409. doi: 10.3390/jcm10225409. |
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