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Background: In the United Kingdom, around 184,000 adults are admitted to an intensive care unit (ICU) each year with over 30% receiving mechanical ventilation. Oxygen is the commonest therapeutic intervention provided to these patients but it is unclear how much oxygen should be administered for the best clinical outcomes. Methods: The UK-ROX trial will evaluate the clinical and cost-effectiveness of conservative oxygen therapy (the minimum oxygen concentration required to maintain an oxygen saturation of 90% ± 2%) versus usual oxygen therapy in critically ill adults receiving supplemental oxygen when invasively mechanically ventilated in ICUs in England, Wales and Northern Ireland. The trial will recruit 16,500 patients from approximately 100 UK adult ICUs. Using a deferred consent model, enrolled participants will be randomly allocated (1:1) to conservative or usual oxygen therapy until ICU discharge or 90 days after randomisation. Objectives: The primary clinical outcome is all cause mortality at 90 days following randomisation. Discussion: The UK-ROX trial has received ethical approval from the South Central - Oxford C Research Ethics Committee (Reference: 20/SC/0423) and the Confidentiality Advisory Group (Reference: 22/CAG/0154). The trial commenced in May 2021 and, at the time of publication, 95 sites had opened to recruitment.
RESUMEN
Background Long-term respiratory effects can occur after COVID-19 pneumonia (CP). The COVID Lung Ultrasound Study (COVIDLUS) aimed to investigate the utility of serial lung ultrasound (LUS) to track functional and physiological recovery after hospitalisation in patients with CP. Methods Between April 2021 and April 2022, 21 patients were recruited at discharge (D0). LUS was performed on D0, day 41 (D41) and day 83 (D83). CT Thorax was performed on D83. Lymphocyte count, Ferritin, Lactate Dehydrogenase, Troponin, CRP, and D-dimers were measured at D0, D41 and D83. 6 minute walking test (6MWT) was performed on D83 and quality of life questionnaires and spirometry completed on D41 and D83. Results 19 subjects completed the study (10 males [52%]; mean age: 52 years [range:37-74]). 1 patient died. LUS scores were significantly higher at D0, compared to D41 and D83 (Mean score:10.9 [D0]/2.8 [D41]/1.5 [D83]; p < 0.0001). LUS scores correlated poorly with CT at D83 (Pearson r2 = 0.28). Mean lymphocyte counts were lower at D0 but increased at D41 and D83. Mean serum Ferritin was significantly lower at D41 and D83, as compared to D0. The mean 6MWT distance was 385 m (130-540 m). Quality of life measures did not differ at D41 and D83. Lung function increased between D41 and D83 with mean increase in FEV1 and FVC of 160 ml and 190 ml respectively. Conclusion LUS can monitor the early recovery of lung interstitial changes from CP. The utility of LUS to predict development of subsequent lung fibrosis post-COVID deserves further study.
