Respiratory Insufficiency Requiring Mechanical VentilationRAVENCT06655805
Registry for Automated Mechanical VEntilation in Adults
An observational study of Respiratory Insufficiency Requiring Mechanical Ventilation, run by Hamilton Medical AG at 4 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency Requiring Mechanical Ventilation
- What is being tested?
- Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 23 Sep 2024to 31 Dec 2030
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Age ≥ 18 years. Any patient in need of HFNO, NIV and IMV at some time during its ICU stay.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Kantonsspital Chur
Chur, Kanton Graubünden, 7000
Francesca Porta, PI, +41812566111, fancesca.porta@ksg.ch
- Recruiting
HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Surgical ICU
Sankt Gallen, Canton of St. Gallen, 9007
Urs Pietsch, MD
- Recruiting
HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Medical ICU
Sankt Gallen, St.Gallen, 9007
Gian-Reto Kleger, MD
- Recruiting
Kantonsspital Winterthur, Zentrum für Intensivmedizin
Winterthur, 8400
Philipp Bühler, MD
About this study
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.
Read the 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.
- Being tested
- Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen
- Keywords
- Real world data, Acute respiratory failure, Respiratory support, Invasive Mechanical Ventilation (IMV), Non Invasive Ventilation (NIV), High Flow Nasal Oxygen (HFNO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygenDevice
No intervention is intended by the nature of this observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 - Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start23 Sep 2024
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Respiratory Insufficiency Requiring Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Hamilton Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesca Porta, MD, Principal investigator, Kantonsspital Chur, Chur, Switerzland 7000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655805
- Sponsor's protocol ID
- HM - RAVE
- Acronym
- RAVE
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26903337Neto AS, Simonis FD, Barbas CS, Biehl M, Determann RM, Elmer J, Friedman G, Gajic O, Goldstein JN, Linko R, Pinheiro de Oliveira R, Sundar S, Talmor D, Wolthuis EK, Gama de Abreu M, Pelosi P, Schultz MJ; PROtective Ventilation Network Investigators. Lung-Protective Ventilation With Low Tidal Volumes and the Occurrence of Pulmonary Complications in Patients Without Acute Respiratory Distress Syndrome: A Systematic Review and Individual Patient Data Analysis. Crit Care Med. 2015 Oct;43(10):2155-63. doi: 10.1097/CCM.0000000000001189.
PubMed 26181219Guo L, Wang W, Zhao N, Guo L, Chi C, Hou W, Wu A, Tong H, Wang Y, Wang C, Li E. Mechanical ventilation strategies for intensive care unit patients without acute lung injury or acute respiratory distress syndrome: a systematic review and network meta-analysis. Crit Care. 2016 Jul 22;20(1):226. doi: 10.1186/s13054-016-1396-0.
PubMed 27448995Campbell RS, Branson RD, Johannigman JA. Adaptive support ventilation. Respir Care Clin N Am. 2001 Sep;7(3):425-40, ix. doi: 10.1016/s1078-5337(05)70049-6.
PubMed 11517032Linton DM, Potgieter PD, Davis S, Fourie AT, Brunner JX, Laubscher TP. Automatic weaning from mechanical ventilation using an adaptive lung ventilation controller. Chest. 1994 Dec;106(6):1843-50. doi: 10.1378/chest.106.6.1843.
PubMed 7988211Brunner JX, Iotti GA. Adaptive Support Ventilation (ASV). Minerva Anestesiol. 2002 May;68(5):365-8.
PubMed 12029247Arnal JM, Wysocki M, Novotni D, Demory D, Lopez R, Donati S, Granier I, Corno G, Durand-Gasselin J. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV(R)) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study. Intensive Care Med. 2012 May;38(5):781-7. doi: 10.1007/s00134-012-2548-6. Epub 2012 Mar 30.
PubMed 22460854Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22.
PubMed 23338569Babic SA, Chatburn RL. Laboratory Evaluation of Cuff Pressure Control Methods. Respir Care. 2020 Jan;65(1):62-67. doi: 10.4187/respcare.06728. Epub 2019 Jul 30.
PubMed 31363001Blakeman T, Rodriquez D Jr, Woods J, Cox D, Elterman J, Branson R. Automated control of endotracheal tube cuff pressure during simulated flight. J Trauma Acute Care Surg. 2016 Nov;81(5 Suppl 2 Proceedings of the 2015 Military Health System Research Symposium):S116-S120. doi: 10.1097/TA.0000000000001234.
PubMed 27602899OTIS AB, FENN WO, RAHN H. Mechanics of breathing in man. J Appl Physiol. 1950 May;2(11):592-607. doi: 10.1152/jappl.1950.2.11.592. No abstract available.
PubMed 15436363MEAD J. The control of respiratory frequency. Ann N Y Acad Sci. 1963 Jun 24;109:724-9. doi: 10.1111/j.1749-6632.1963.tb13500.x. No abstract available.
PubMed 13934289Botta M, Wenstedt EFE, Tsonas AM, Buiteman-Kruizinga LA, van Meenen DMP, Korsten HHM, Horn J, Paulus F, Bindels AGJH, Schultz MJ, De Bie AJR. Effectiveness, safety and efficacy of INTELLiVENT-adaptive support ventilation, a closed-loop ventilation mode for use in ICU patients - a systematic review. Expert Rev Respir Med. 2021 Nov;15(11):1403-1413. doi: 10.1080/17476348.2021.1933450. Epub 2021 Jul 31.
PubMed 34047244Buiteman-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.
PubMed 34830691Chelly J, Mazerand S, Jochmans S, Weyer CM, Pourcine F, Ellrodt O, Thieulot-Rolin N, Serbource-Goguel J, Sy O, Vong LVP, Monchi M. Automated vs. conventional ventilation in the ICU: a randomized controlled crossover trial comparing blood oxygen saturation during daily nursing procedures (I-NURSING). Crit Care. 2020 Jul 22;24(1):453. doi: 10.1186/s13054-020-03155-3.
PubMed 32698860
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Automated Mechanical VEntilation in Adults
- ClinicalTrials.gov ID
- NCT06655805
- Acronym / sponsor ID
- RAVE / HM - RAVE
- Keywords
- Real world data, Acute respiratory failure, Respiratory support, Invasive Mechanical Ventilation (IMV), Non Invasive Ventilation (NIV), High Flow Nasal Oxygen (HFNO)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hamilton Medical AGIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One cohort of consecutive patients | – | Device: Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygenOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- Age ≥ 18 years. Any patient in need of HFNO, NIV and IMV at some time during its ICU stay.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygenNo intervention is intended by the nature of this observational study. | Device | One cohort of consecutive patients |
Primary outcome
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:
Time frame: 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:
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 26903337Bellani 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.
- Background: PubMed 26181219Neto AS, Simonis FD, Barbas CS, Biehl M, Determann RM, Elmer J, Friedman G, Gajic O, Goldstein JN, Linko R, Pinheiro de Oliveira R, Sundar S, Talmor D, Wolthuis EK, Gama de Abreu M, Pelosi P, Schultz MJ; PROtective Ventilation Network Investigators. Lung-Protective Ventilation With Low Tidal Volumes and the Occurrence of Pulmonary Complications in Patients Without Acute Respiratory Distress Syndrome: A Systematic Review and Individual Patient Data Analysis. Crit Care Med. 2015 Oct;43(10):2155-63. doi: 10.1097/CCM.0000000000001189.
- Background: PubMed 27448995Guo L, Wang W, Zhao N, Guo L, Chi C, Hou W, Wu A, Tong H, Wang Y, Wang C, Li E. Mechanical ventilation strategies for intensive care unit patients without acute lung injury or acute respiratory distress syndrome: a systematic review and network meta-analysis. Crit Care. 2016 Jul 22;20(1):226. doi: 10.1186/s13054-016-1396-0.
- Background: PubMed 11517032Campbell RS, Branson RD, Johannigman JA. Adaptive support ventilation. Respir Care Clin N Am. 2001 Sep;7(3):425-40, ix. doi: 10.1016/s1078-5337(05)70049-6.
- Background: PubMed 7988211Linton DM, Potgieter PD, Davis S, Fourie AT, Brunner JX, Laubscher TP. Automatic weaning from mechanical ventilation using an adaptive lung ventilation controller. Chest. 1994 Dec;106(6):1843-50. doi: 10.1378/chest.106.6.1843.
- Background: PubMed 12029247Brunner JX, Iotti GA. Adaptive Support Ventilation (ASV). Minerva Anestesiol. 2002 May;68(5):365-8.
- Background: PubMed 22460854Arnal JM, Wysocki M, Novotni D, Demory D, Lopez R, Donati S, Granier I, Corno G, Durand-Gasselin J. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV(R)) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study. Intensive Care Med. 2012 May;38(5):781-7. doi: 10.1007/s00134-012-2548-6. Epub 2012 Mar 30.
- Background: PubMed 23338569Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22.
- Background: PubMed 31363001Babic SA, Chatburn RL. Laboratory Evaluation of Cuff Pressure Control Methods. Respir Care. 2020 Jan;65(1):62-67. doi: 10.4187/respcare.06728. Epub 2019 Jul 30.
- Background: PubMed 27602899Blakeman T, Rodriquez D Jr, Woods J, Cox D, Elterman J, Branson R. Automated control of endotracheal tube cuff pressure during simulated flight. J Trauma Acute Care Surg. 2016 Nov;81(5 Suppl 2 Proceedings of the 2015 Military Health System Research Symposium):S116-S120. doi: 10.1097/TA.0000000000001234.
- Background: PubMed 15436363OTIS AB, FENN WO, RAHN H. Mechanics of breathing in man. J Appl Physiol. 1950 May;2(11):592-607. doi: 10.1152/jappl.1950.2.11.592. No abstract available.
- Background: PubMed 13934289MEAD J. The control of respiratory frequency. Ann N Y Acad Sci. 1963 Jun 24;109:724-9. doi: 10.1111/j.1749-6632.1963.tb13500.x. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Porta, MD principal investigator
Kantonsspital Chur, Chur, Switerzland 7000
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency Requiring Mechanical Ventilation, run by Hamilton Medical AG at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco V Maggiorini, MD (+41586101514, mmaggiorini@hamilton-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: (time frame: Day 0 - Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06655805, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.