Registry for Automated Mechanical VEntilation in Adults

NCT06655805 | Recruiting

• 1 other identifier: HM - RAVE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation

Keywords

Real world data; Acute respiratory failure; Respiratory support; Invasive Mechanical Ventilation (IMV); Non Invasive Ventilation (NIV); High Flow Nasal Oxygen (HFNO)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen

Interventions

Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen DEVICE

No intervention is intended by the nature of this observational study.

One cohort of consecutive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age ≥ 18 years. Any patient in need of HFNO, NIV and IMV at some time during its ICU stay.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Medical AG: lead

Study Sites (4)

HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Surgical ICU

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Kantonsspital Chur

Chur, Kanton Graubünden, 7000, Switzerland

RECRUITING

HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Medical ICU

Sankt Gallen, St.Gallen, 9007, Switzerland

RECRUITING

Kantonsspital Winterthur, Zentrum für Intensivmedizin

Winterthur, 8400, Switzerland

RECRUITING

Related Publications (18)

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  PMID: 26903337 BACKGROUND

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  PMID: 31363001 BACKGROUND

• Blakeman 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.

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  PMID: 13934289 BACKGROUND

• Botta 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.

  PMID: 34047244 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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  PMID: 26976648 BACKGROUND

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Francesca Porta, MD

  Kantonsspital Chur, Chur, Switerzland 7000

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco V Maggiorini, MD

CONTACT

+41586101514; mmaggiorini@hamilton-medical.com

Dominik Novotni, MD

CONTACT

+41586101514; dnovotni@hamilton-medical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)