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Article History

Received: 30 April 2024

Accepted: 30 September 2024

First Online: 9 November 2024

Declarations

:

: There are currently no conflicts of interest. SR and DSK have previously been minor shareholders of Mermaid Care A/S who manufactured the BEACON Caresystem, but no longer have any association with the current owners of the commercial rights to the system and as such would not benefit from future commercialisation. Mermaid Care provided study funding, training in use of the system and technical support during the study. Mermaid Care had access to data, blinded by arm, for internal quality control and regulatory issues, but had no role in data analysis for this manuscript.

: Ethical approval was obtained from the regional ethics committee of the HRC (Date 22/08/17, REC reference 17/LO/0997, IRAS reference 226,610) and was prospectively registered (ClinicalTrials.gov ID: NCT03249623). This study was also registered with the National Institute for Health Research (NIHR) (CPMS ID: 34,831) and endorsed by the European Society for Intensive Care Medicine (ESICM). The study was conducted in compliance with the Declaration of Helsinki, the Code of Ethics of the World Medical Association for experiments involving humans and Local Regulatory Requirements. Five clinical sites in the UK were involved in patient recruitment, with sites added during the study period. These were located at the Chelsea and Westminster Hospital (CW), West Middlesex University Hospital (WM), North Middlesex University Hospital (NM), Norwich and Norfolk University Hospital (NN), and Liverpool University Hospital (LU). Safety oversight was under the direction of an independent committee coordinated by the Research & Development team at Chelsea & Westminster NHS Foundation Trust.

: All patients were screened for eligibility on admission to the ICU by the research team. Following screening, consent was obtained either from the patient where capable, a relative/personal consultee, or if not possible, a nominated professional consultee from outside the research group. Patients were randomized into the intervention arm, where BC advice was available, or to usual care (see ESM, Fig. S.1.1). Patients were included if adult, had > 24 h invasive mechanical ventilation; if the ventilator and mode was supported by the BC; and if haemodynamically stable. Patients were excluded according to the criteria in the ESM (ESM S.4), which includes: history of home ventilation or multiple ICU admissions; if catagorised as patient with a primary neurological disorder or with head trauma; on the presence of severe heart failure, end stage liver disease or morbid obesity; or if clinical conditions required treatment with ECMO. Patients randomized to either arm were connected to the BC system via a flow and gas sensor connection placed in the main ventilation flow to and from the patient (see Measurements).