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.

It has been reported that pregnant women used more cosmetics daily than non-pregnant women. Phenoxyacetic acid is the main metabolite of phenoxyethanol, the most frequent preservative in cosmetics used in Europe, previously associated with reproductive effects (longer time to conception, endocrine disruptors in newborns and poorer verbal comprehension in children). In France, specialised platforms (PREVention ENvIronment Reproduction (PREVENIR)) in university hospital maternity wards are dedicated to evaluating environmental and occupational exposures in patients with pregnancy-related pathologies and supporting targeted prevention efforts. These platforms are composed of occupational health physicians, obstetrician-gynaecologists, midwives, occupational health nurses, and occupational health and environmental engineers. To assess the efficacy of these platforms, we developed a randomised clinical trial, the protocol for which is presented in this paper. The primary objective of the PREVENIR-G Study is to compare the change in urinary phenoxyacetic acid concentrations from baseline to 3 months postintervention between an intervention group and a control group. To date, the intervention has been integrated into routine care in certain facilities; however, its efficacy remains unproven. It is therefore essential to assess the relevance of this intervention, considering both its potential benefits and any adverse effects, such as increased stress or anxiety.

This study is an unblinded, randomised clinical superiority trial with two parallel groups (intervention vs no intervention) in four university maternity hospitals in France. We will include 300 pregnant women (aged 18 years or older) who are under 24 weeks of gestation (150 per group) referred to the participating PREVENIR platforms for management. The intervention will consist of clinical prevention management through the PREVENIR platforms, involving a consultation with an environmental health expert for an assessment of environmental and occupational exposures. During the consultation, targeted prevention messages will be provided based on identified exposures. The no intervention comparator will be a waiting-list control group. At the inclusion visit, patients will receive urine collection vials for samples to be collected at baseline and again at 3 months. Urine samples will be collected twice in a single day, on three separate days, during the collection week at home. In the week following the urine collection period, only participants in the intervention group will engage with the PREVENIR platforms. The primary outcome will be the difference in the urinary phenoxyacetic acid concentration between baseline and 3 months postintervention, compared between the intervention and control groups.

The study has been approved by the hospital ethics committee (CCP Ouest 2, no. 2023-A00941-44). All participants will provide written informed consent. Results will be shared through presentations and publications.

NCT06642818