The aim of this study is to assess the ethnic and racial demographics of patients enrolled in prospective chronic rhinosinusitis (CRS) studies relative to the corresponding geographic demographics of the United States (U.S.) census data.Study Design: Systematic Review and Population analysis. Methods: A systematic review was performed to identify CRS clinical trials, conducted in the U.S. and published between 2010 and 2020 in which patients were prospectively enrolled. Pooled racial and ethnicity data were compared to national and corresponding regional census data.Results: Eighty-three studies were included, comprising 12,027 patients. 50.4% were male and the average age was 49.2 years. 8,810 patients underwent a surgical procedure. Of the 12,027 patients, 81.67% were identified as White, 5.35% as Black, 1.27% as Asian, 0.02% as Pacific Islander, 0.12% as American Indian, and 11.57% were classified as Other. The racial and ethnic composition of the pooled study population differs significantly from the national U.S. census data with the underrepresentation of each minority population (P ≤ .0002). Regional sub-analyses yield variable results. In the Northeast and West, there was an underrepresentation of all minority populations. In the South and Midwest, Black enrollment was similar to the U.S. census data, while all other minorities were underrepresented.Conclusions: The racial and ethnic composition of patients enrolled in prospective CRS clinical trials differs significantly from the demographics of the U.S. population. The generalizability and external validity of findings derived from studies comprised of demographically mismatched populations has not been established. Future efforts to enroll more representative populations should be emphasized by the research community, funding bodies, and editorial boards.
Purpose: Poorer short-term outcomes have been described for females after cardiovascular surgery. We examined the influence of sex on the outcomes after aortic root replacement (ARR). Methods: Medical records of 848 patients (females, n = 159/848, 19%) who underwent ARR at our center from 2005 to 2018 were retrospectively reviewed. Sex differences of the following outcomes were analyzed: the primary end point (inhospital mortality or stro111ke), secondary end point (new requirement for permanent pacemaker), and long-term survival (median follow-up 21.4 months [interquartile range,1.3-60.0]).Results: Females were significantly older (61.3 vs 58.7 [male]) with higher rates of pre-existing cerebrovascular disease (14% [22/159] vs 7% [52/689]) and previous valve intervention (20% [32/159] vs 13% [89/689]) but less myocardial infarction [1%(1/159) vs 7%(48/689)]. The surgical indication was different (aneurysm 75% [120/159] vs 87% [602/689], dissection 13% [21/159] vs 6% [41/689]; P < .01]). Females had larger average aneurysm size after controlling for body size (P ≤ .001). There was no sex difference in in-hospital mortality (3% [5/159] vs 2% [16/689]) or stroke (4% [7/159] vs 4% [29/689]). Multivariable logistic regression indicated that female sex was not an independent predictor of combined in-hospital stroke or death (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.28-1.25), confirmed by propensity score analysis. There was no difference in long-term survival (5-year survival, 90.96% vs 93.03%; P = .44). Females had higher incidence of permanent pacemaker requirement [11% (18/159) vs 6% (39/689), P = .03] and female sex was an independent predictor of permanent pacemaker requirement (OR, 2.01; 95% CI, 1.085-3.724; P = .03).
The aim is to use a simulation lung model to assess the possibility of performing bronchoscopy through endotracheal tubes (ETT) less than 8.0-mm while appropriately ventilating patients with normal and ARDS lungs in the setting of SARS-CoV-2.Methods: Five SHERIDAN ® ETTs were used to ventilate SimMan ® 3G under respiratory compliance levels representing normal and severe ARDS lungs. Baseline measurements of peak pressure, plateau pressure, and auto-positive end expiratory pressure (auto-PEEP) were recorded at four different inspiratory times (Ti). Three different-sized disposable bronchoscopes were inserted, and all measurements were repeated.Results: Normal lung model: Slim bronchoscopes in 6.0-mm ETTs resulted in plateau pressures <30 cm H 2 O, and increasing Ti to minimize peak pressure resulted in low auto-PEEP. Regular bronchoscopes in 7.0-mm ETTs had similar results. Large bronchoscopes in 7.5-mm ETTs generated plateau pressures ranging from 28 to 35 cm H 2 O with modest auto-PEEP. Severe ARDS lung model: Slim bronchoscopes in 6.0-mm ETTs resulted in plateau pressures of 46 and an auto-PEEP of 5 cm H 2 O. Regular bronchoscopes in 7.0-mm ETTs generated similar results. Large bronchoscopes in 8.0-mm ETTs displayed plateau pressures of 44 and an auto-PEEP of 2 cm H 2 O.Conclusion: To mitigate risk of laryngeal injury, larger ETTs during bronchoscopy should be avoided. Our data show bronchoscopy with any ETT causes auto-PEEP and high plateau pressures, especially in lungs with poor compliance; however, ETT less than 7.5 mm can be used when considering several factors. Our data also suggest similar studies in patients with varying degrees of ARDS would be informative.
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