Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a study protocol for a multicentre adaptive randomised controlled trial

BACKGROUND: High-flow nasal therapy is a non-invasive form of respiratory support that delivers low-level, flow dependent positive airway pressure. The device can be better tolerated by patients than alternatives such as continuous positive airway pressure. The primary objective is to determine if prophylactic high-flow nasal therapy after tracheal extubation can result in an increase in the number of days alive and at home within the first 90 days after surgery, when compared with standard oxygen therapy. The co-primary objective is to estimate the incremental cost-effectiveness and cost-utility of high-flow nasal therapy vs standard oxygen therapy at 90 days, from the view-point of the public sector, the health service and patients. METHODS: This is an adaptive, multicentre, international parallel-group, randomised controlled trial with embedded cost-effectiveness analysis comparing the use of high-flow nasal therapy with control in patients at high risk of respiratory complications following cardiac surgery. Participants will be randomised before tracheal extubation and allocated either high-flow nasal therapy or standard oxygen therapy for a minimum of 16 h immediately post extubation. Participants will be followed up until 90 days after surgery. The total sample size needed to detect a 2-day increase in DAH90 with 90% power with an intention to treat analysis is 850 patients. The adaptive design includes an interim sample size re-estimation which will provide protection against deviations from the original sample size assumptions made from the single-centre pilot study and will allow for a maximum sample size increase to 1152 patients. DISCUSSION: Evidence to support routine use of high-flow nasal therapy will inform the development of effective enhanced recovery care bundles. Reducing complications should reduce length of stay and re-admission to hospital and provide an important focus for cost reduction. However; high-quality studies evaluating the clinical and cost effectiveness of high-flow nasal therapy after cardiothoracic surgery are lacking. TRIAL REGISTRATION: The study has been registered with ISRCTN (ISRCTN14092678, 13/05/2020) Clinicaltrials.gov Registration Pending