To evaluate the feasibility, safety and acceptability of arm crank ergometry cardiopulmonary exercise testing (CPETarm) in patients with chronic limb threatening ischaemia (CLTI).

Prospective feasibility single-arm cohort study.

A tertiary vascular surgery referral centre in Greater Manchester, UK.

Adult inpatients admitted with CLTI and scheduled for non-elective vascular intervention.

Participants underwent bedside CPETarm using an incremental ramp protocol. Cardiopulmonary parameters measured included peak oxygen uptake, anaerobic threshold (AT), ventilatory equivalent for carbon dioxide at AT, peak work rate, oxygen pulse, maximum heart rate and respiratory exchange ratio.

Primary outcomes were feasibility domains including eligibility, recruitment, test completion, safety, practicality, implementation and patient acceptability. Secondary outcomes included the ability to obtain clinically relevant CPET variables for perioperative risk stratification.

60 patients underwent CPETarm. 74% of CLTI inpatients met eligibility criteria and 71% of eligible patients consented to testing. CPETarm was completed to volitional exhaustion by 95% of participants, with anaerobic threshold identified in 68%. No major adverse events occurred during testing or within 24 hours post-test. 90% of CPETarm assessments were completed within 48 hours of the decision to proceed with intervention, without delaying surgery. The procedure was well tolerated and acceptable to patients.

CPETarm is a feasible, safe and acceptable method for preoperative assessment in patients with CLTI who are unsuitable for conventional lower-limb CPET. Further research is required to establish modality-specific thresholds, evaluate prognostic value for postoperative outcomes and evaluate integration into perioperative care pathways.

NCT06404229.

Paediatric anxiety disorders are among the most common psychiatric disorders of childhood and adolescence, affecting between 15% and 30% of youth. Rates rose sharply during the COVID-19 pandemic, and untreated anxiety is associated with impaired functioning and increased risk of depression, suicidality and substance use in adulthood. Evidence-based treatments such as cognitive-behavioural therapy and selective serotonin reuptake inhibitors are highly effective yet remain underused, while non-recommended treatments, including benzodiazepines, are often prescribed. Despite the public health burden, there are currently no endorsed outcome-focused quality measures for paediatric anxiety. Developing such measures would allow health systems and providers to track outcomes, reduce disparities and drive quality improvement.

This study will develop and test two complementary outcome-focused paediatric anxiety quality measures based on the seven-item Generalised Anxiety Disorder scale: (1) remission (clinically significant reduction in anxiety symptoms to below threshold) and (2) response (clinically significant improvement, even if remission is not achieved). Using electronic health record and claims data from Kaiser Permanente Northwest and Kaiser Permanente Southern California from 2017 to 2024, we will establish measure inclusion and exclusion criteria, evaluate the application of symptom weighting, test measure reliability and validity and implement casemix adjustment models. Analyses will examine disparities by race, ethnicity and social risk factors through linkage indices capturing local social determinants of health. Qualitative interviews with providers and electronic medical record vendors will be conducted to assess feasibility and usability. Measures will be prepared and submitted for endorsement by a national quality measurement body.

This study has been reviewed and approved by the institutional review boards at RTI International and Kaiser Permanente. Findings will be disseminated through peer-reviewed publications, scientific conferences, stakeholder workshops and submissions to a national quality endorsement body.

Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO₂) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO₂ 90%–96%) compared with usual care.

The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO₂ 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO₂2 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.

The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.

NCT06374225.

Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m². Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.