Registry for Automated Mechanical VEntilation in Adults

Overview

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.

Interventions

• Device Non-invasive ventilation, Invasive mechanical ventilation, high-flow nasal oxygen
  No intervention is intended by the nature of this observational study.

Primary outcome measures

• 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 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Switzerland · 4 centers

• HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Surgical ICU — Sankt Gallen
• Kantonsspital Chur — Chur
• HOCH Health Ostschweiz, Clinics for Intensive Care Medicine, Medical ICU — Sankt Gallen
• Kantonsspital Winterthur, Zentrum für Intensivmedizin — Winterthur

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. d PMID 26903337
• Neto 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 Syndro PMID 26181219
• Guo 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. PMID 27448995
• Campbell 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. PMID 11517032
• Linton 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. PMID 7988211
• Brunner JX, Iotti GA. Adaptive Support Ventilation (ASV). Minerva Anestesiol. 2002 May;68(5):365-8. PMID 12029247
• Arnal 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. PMID 22460854
• Lellouche 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. PMID 23338569

Identifiers

NCT: NCT06655805 · HM - RAVE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗