Perioperative monitoring requires clinicians to integrate multiple physiological data streams while managing interruptions and audible alarms. The Visual Patient Avatar (VPA) is an avatar-based monitor visualisation that integrates vital signs and sensor states into an animated virtual patient. This protocol evaluates whether VPA implementation is associated with objective changes in monitoring and alarm outcomes during routine perioperative care.

This investigator-initiated, dual-centre, quasi-experimental pre-post observational study uses routine perioperative monitoring and alarm data from NewYork-Presbyterian/Weill Cornell, USA and University Hospital Zurich, Switzerland. It includes approximately 58 000 anaesthesia cases (16 000 and 42 000, respectively); adult and paediatric cases will be analysed separately. Data span pre-implementation, adaptation and post implementation phases; technical deployment intervals are excluded. Each anaesthesia case is one unit of analysis. The primary outcome is the duration of vital-sign deviation per 60 min of valid measurement. Secondary outcomes are a time-based area under the curve metric and audible alarm burden (count, time and reaction time). Multivariable models will adjust for patient, procedure and care-context covariates. Analyses will be performed separately by centre.

The Weill Cornell Medicine Institutional Review Board approved the study and granted a waiver of informed consent (IRB No. 22-05024803). At University Hospital Zurich, only cases from patients with written general consent for research use of routinely collected health data were included. The Cantonal Ethics Committee Zurich issued a declaration of non-jurisdiction (BASEC Req-2021-00756; 6 July 2021), and the University Hospital Zurich Data Governance Board approved data export and anonymisation (DGR0000504; 31 January 2025). A data-sharing agreement was established on 11 April 2023. Data-collection windows are complete; extraction, linkage and quality control are ongoing, and no comparative outcome analyses have been performed. Findings will be disseminated through peer-reviewed publications and conferences.

Early open fracture management aims to minimise the risk of complications. For the most severe open fracture wounds, multiple irrigation and debridement surgeries are required to overcome severe wound contamination, to reassess the evolving tissue injury or to temporise and plan further surgery. When multiple irrigation and debridement surgeries are needed, uncertainty remains about how the open fracture wound should be managed to best minimise complications. The primary aim of this trial is to compare the antibiotic cement bead pouch vs negative pressure wound therapy in the management of patients with severe open tibia fracture wounds.

BvV is a multicentre, pragmatic, parallel arm randomised controlled trial that aims to enrol 312 adult patients admitted to a participating centre with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Participants will be randomly allocated on a 1:1 basis to either antibiotic cement bead pouch or negative pressure wound therapy. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomisation. Using the win ratio approach, we will hierarchically assess the composite outcome in the following order: (i) all-cause mortality, (ii) injury-related amputation of the lower extremity, (iii) unplanned reoperation to manage wound complications, an infection or promote fracture healing and (iv) clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.

The BvV trial has been approved by a central institutional review board (IRB) (Advarra) for clinical sites in the USA, the ethics board at the coordinating centre at McMaster University (Hamilton Integrated Research Ethics Board), and participating sites not using the central institutional IRB (Fraser Health Research Ethics Board, The University of British Columbia Clinical Research Ethics Board, Newfoundland and Labrador Health Research Ethics Board, University of Manitoba Biomedical Research Ethics Board). Additional clinical sites who are in the start-up phase, as well as any new selected clinical sites, will obtain local approvals prior to initiating trial activities. This will include a clinical site in the UK who is in the process of obtaining the necessary approvals. Recruitment began in November 2023. Both interventions are frequently used to manage severe open fracture wounds, ensuring that the trial results can be easily transitioned into clinical practice. The results of this trial will be disseminated to national and international partners through peer-reviewed publications, academic conferences and stakeholder engagement activities.

NCT05615844.