Poor cardiopulmonary fitness is an important risk factor for postoperative complications, yet a feasible, objective and prognostically accurate method to assess preoperative fitness has not been established. The 6 min walk test (6MWT) is a simple, inexpensive and widely applicable measure that shows promise for predicting postoperative risk. However, robust data are lacking on whether the 6MWT accurately predicts complications, provides incremental prognostic value beyond routinely collected clinical factors or outperforms simpler alternatives such as questionnaires, cardiac biomarkers or grip strength testing. The Functional Assessment for Surgery by a Timed Walk (FAST Walk) study is designed to address these knowledge gaps by evaluating whether the 6MWT improves prediction of key postoperative outcomes compared with clinical factors and simpler measures of fitness.

The FAST Walk study is an international multicentre prospective cohort study of 1672 adults (≥40 years) undergoing major elective non-cardiac surgery at centres in Canada, Hong Kong, Australia, Spain and the Netherlands. Participants complete a preoperative 6MWT and baseline assessments of comorbidities, self-reported cardiopulmonary fitness (MET: Re-evaluation for Perioperative Cardiac Risk questionnaire), biomarkers (N-terminal pro-B-type natriuretic peptide) and grip strength. The primary outcome is 30-day death or major postoperative complication, defined as Clavien-Dindo grade II or higher. Secondary outcomes are (1) death or new significant disability at 90 days after surgery and (2) days alive and out of hospital at 30 days after surgery. Disability is measured using the short-form WHO Disability Assessment Schedule 2.0 instrument. Multivariable regression models and complementary metrics of prediction performance will be used to determine whether 6MWT distance adds prognostic value beyond routinely collected clinical factors and simpler measures of fitness.

The FAST Walk study has received research ethics board approval at all participating sites. Recruitment commenced in June 2024, with completion of participant follow-up expected in 2026. Findings will be disseminated through peer-reviewed publications and conference presentations, with the primary results anticipated in 2027.

NCT06412367.

Acute hypoxaemic respiratory failure is a common reason for intensive care unit (ICU) admission. Non-invasive respiratory support strategies such as high-flow nasal oxygen (HFNO) and helmet non-invasive ventilation may reduce the need for invasive mechanical ventilation and death. The High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure pilot trial is designed to compare helmet non-invasive ventilation combined with HFNO vs HFNO alone in patients with acute hypoxaemic respiratory failure and to determine the feasibility of a larger randomised controlled trial.

This is a pragmatic, open-label, multicentre randomised controlled pilot trial enrolling 200 critically ill adults with acute hypoxaemic respiratory failure across 12 Canadian ICUs. Participants are randomised 1 to 1 to receive either helmet non-invasive ventilation plus HFNO or HFNO alone for at least 48 hours. The primary aim is to assess feasibility metrics including recruitment rate, protocol adherence and fidelity to pre-specified intubation criteria. Secondary outcomes include rates of intubation, all-cause mortality, ventilator-free days, ICU length of stay and quality of life at 6 months. Primary and secondary outcomes will be analysed using Bayesian methods.

Ethics approval has been obtained at all participating centres. Findings will inform the feasibility and design of a future full-scale trial and be disseminated through peer review publications and conference presentations.

ClinicalTrials.gov Identifier: NCT05078034.