An implementation-effectiveness trial investigating feasibility, safety and efficacy of Best pRacticE guideline cAre physioTHErapy with addition of protocolised ventilator hyperinflation on patient-important outcomes for critically ill adults intUbated and ventilated with Pneumonia. (BREATHE UP)

Pneumonia is a common cause for intensive care unit (ICU) admission for breathing support from a mechanical ventilator, resulting in high morbidity, mortality, and healthcare costs. Physiotherapists working in ICU treat patients with critical pneumonia using a range of respiratory treatments to improve breathing, hasten weaning from the ventilator, and restore functional independence. Evidence supports the short-term benefits of these treatments, however currently no standard of physiotherapy practice exists for these ICU patients. Despite a plethora of studies which have shown that physiotherapy treatments, such as ventilator lung hyperinflation (VHI), aid the lungs to work better short-term, there are no studies to date which investigate the effect of these important treatments on meaningful patient-important outcomes, such as earlier weaning from the ventilator, earlier hospital discharge, less breathlessness and lung secretions, short- and longer-term disability, health- related quality of life and survival. Through previous multiphase mixed-methods research, a clinical practice guideline was developed outlining best physiotherapy practice for this ICU patient cohort. This proposed research involves conducting a multicentre hybrid implementation-effectiveness randomised, controlled trial which aims to: evaluate implementation of physiotherapy guideline care for management of pneumonia in ICU regarding feasibility, safety and acceptability; and to determine the safety and effectiveness of a standardised dosage of daily ventilator hyperinflation in addition to standard guideline care on patient-important outcomes, health system outcomes; and cost effectiveness. This study will address critical knowledge gaps in the ICU physiotherapy evidence base regarding the impact of a course of standardised, best practice respiratory physiotherapy intervention during the ICU stay for patients with critical pneumonia requiring invasive mechanical ventilation, provide valuable information for clinicians to inform clinical practice regarding treatable traits and streamlining care to promote clinical efficiency, and determine the impact of respiratory physiotherapy care on patient-important and health service outcomes. Trial registrationANZ Clinical trials Registry number ACTRN12624001130550.