Subject(s)
COVID-19 , Humans , Informed Consent , Prone Position , Respiration, Artificial , SARS-CoV-2ABSTRACT
OBJECTIVES: To assess the effectiveness of prone positioning to reduce the risk of death or respiratory failure in non-critically ill patients admitted to hospital with covid-19. DESIGN: Multicentre pragmatic randomised clinical trial. SETTING: 15 hospitals in Canada and the United States from May 2020 until May 2021. PARTICIPANTS: Eligible patients had a laboratory confirmed or a clinically highly suspected diagnosis of covid-19, needed supplemental oxygen (up to 50% fraction of inspired oxygen), and were able to independently lie prone with verbal instruction. Of the 570 patients who were assessed for eligibility, 257 were randomised and 248 were included in the analysis. INTERVENTION: Patients were randomised 1:1 to prone positioning (that is, instructing a patient to lie on their stomach while they are in bed) or standard of care (that is, no instruction to adopt prone position). MAIN OUTCOME MEASURES: The primary outcome was a composite of in-hospital death, mechanical ventilation, or worsening respiratory failure defined as needing at least 60% fraction of inspired oxygen for at least 24 hours. Secondary outcomes included the change in the ratio of oxygen saturation to fraction of inspired oxygen. RESULTS: The trial was stopped early on the basis of futility for the pre-specified primary outcome. The median time from hospital admission until randomisation was 1 day, the median age of patients was 56 (interquartile range 45-65) years, 89 (36%) patients were female, and 222 (90%) were receiving oxygen via nasal prongs at the time of randomisation. The median time spent prone in the first 72 hours was 6 (1.5-12.8) hours in total for the prone arm compared with 0 (0-2) hours in the control arm. The risk of the primary outcome was similar between the prone group (18 (14%) events) and the standard care group (17 (14%) events) (odds ratio 0.92, 95% confidence interval 0.44 to 1.92). The change in the ratio of oxygen saturation to fraction of inspired oxygen after 72 hours was similar for patients randomised to prone positioning and standard of care. CONCLUSION: Among non-critically ill patients with hypoxaemia who were admitted to hospital with covid-19, a multifaceted intervention to increase prone positioning did not improve outcomes. However, wide confidence intervals preclude definitively ruling out benefit or harm. Adherence to prone positioning was poor, despite multiple efforts to increase it. Subsequent trials of prone positioning should aim to develop strategies to improve adherence to awake prone positioning. STUDY REGISTRATION: ClinicalTrials.gov NCT04383613.
Subject(s)
COVID-19 , Aged , COVID-19/complications , Female , Hospital Mortality , Humans , Hypoxia/etiology , Hypoxia/therapy , Middle Aged , Patient Positioning , Prone PositionABSTRACT
OBJECTIVE: Systemic sclerosis (SSc) has a female predominance, however, little is understood about the effect of sex on SSc manifestations and survival. The objectives of our study were to evaluate differences in disease manifestations, and survival rates between males and females with SSc. METHODS: A retrospective cohort study of the Toronto Scleroderma Program was conducted to evaluate sex-based differences in disease manifestations and survival. A relative survival analysis compared SSc survival to the general population. RESULTS: There were 959 patients (791 females, 168 males) identified, with a female:male ratio of 4.7:1. Males more frequently had diffuse SSc [45% vs 30%, relative risk (RR) 1.44, 95% CI 1.18-1.75] and interstitial lung disease (ILD; 41% vs 33%, RR 1.24, 95% CI 1.01-1.52). There were 324 deaths (65 males, 259 females). Males had increased unadjusted mortality compared to females (HR 1.57, 95% CI 1.19-2.06). In an adjusted model including immunosuppressive use, male sex (HR 1.40, 95% CI 1.06-1.85), ILD (HR 1.58, 95% CI 1.26-1.98), and older age at diagnosis (HR 1.05, 95% CI 1.04-1.06) were independently associated with increased mortality, whereas the limited subtype (HR 0.70, 95% CI 0.49-0.77) and anticentromere antibodies (HR 0.70, 95% CI 0.49-0.98) were independently associated with decreased mortality. Male sex was associated with increased risk of mortality (HR 1.16, p=0.003) in patients with SSc above that observed for males in the general population. CONCLUSION: The differential effect of disease between sexes is small, yet males have decreased survival compared to females with SSc.
