Effect of Prone Positioning on Clinical Outcomes of Non-Intubated Subjects With COVID-19.

BACKGROUND: Awake prone positioning (APP) has been recently proposed as an adjunctive treatment for non-intubated coronavirus disease 2019 (COVID-19) patients requiring oxygen therapy to improve oxygenation and reduce the risk of intubation. However, the magnitude of the effect of APP on clinical outcomes in these patients remains uncertain. We performed a comparative systematic review and meta-analysis to evaluate the effectiveness of APP to improve the clinical outcomes in non-intubated subjects with COVID-19. METHODS: The primary outcomes were the need for endotracheal intubation and mortality. The secondary outcome was hospital length of stay. Pooled risk ratio (RR) and mean difference with the corresponding 95% CI were obtained by the Mantel-Haenszel method within a random-effect model. RESULTS: A total of 14 studies (5 randomized controlled trials [RCTs] and 9 observational studies) involving 3,324 subjects (1,495 received APP and 1,829 did not) were included. There was a significant reduction in the mortality rate in APP group compared to control (RR 0.68 [95% CI 0.51-0.90]; P = .008, I2 = 52%) with no significant effect on intubation (RR 0.85 [95% CI 0.66-1.08]; P = .17, I2 = 63%) or hospital length of stay (mean difference -3.09 d [95% CI-10.14-3.96]; P = .39, I2 = 97%). Subgroup analysis of RCTs showed significant reduction in intubation rate (RR 0.83 [95% CI 0.72-0.97]; P = .02, I2 = 0%). CONCLUSIONS: APP has the potential to reduce the in-hospital mortality rate in COVID-19 subjects with hypoxemia without a significant effect on the need for intubation or length of hospital stay. However, there was a significant decrease in the need for intubation on subgroup analysis of RCTs. More large-scale trials with a standardized protocol for prone positioning are needed to better evaluate its effectiveness in this select population.

Does a Starting Positive End-Expiratory Pressure of 8 cmH2O Decrease the Probability of a Ventilator-Associated Event?

Introduction: Ventilator-associated events (VAEs) are objective measures as defined by the Centers for Disease Control and Prevention (CDC). To reduce VAEs, some hospitals have started patients on higher baseline positive end-expiratory pressure (PEEP) to avoid triggering VAE criteria due to respiratory fluctuations. Methods: At our institution, VAEs were gathered from January 2014 through December 2019. Using the CDC-defined classifications, VAEs were split into two groups to separate patients with hypoxemia only (VAC) and those with hypoxemia and evidence of inflammation or infection (IVAC-plus). We used the geometric distribution to calculate the daily event probability before and after the protocol implementation. A probability threshold was used to determine if the days between events was exceeded during the post-protocol period. Results: A total of 306 VAEs were collected over the study period. Of those, 155 were VACs and 107 were IVAC-plus events during the pre-protocol period. After implementing the protocol, 24 VACs and 20 IVAC-plus events were reported. There was a non-significant decrease in daily event probabilities in both the VAC and IVAC-plus groups (0.083 vs. 0.068 and 0.057 vs. 0.039, respectively). Conclusion: We concluded a starting PEEP of 8 cmH2O is unlikely to be an effective intervention at reducing the probability of a VAE. Until specific guidelines by the CDC are established, hospitals should consider alternative methods to reduce VAEs.

Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS. TRIAL DESIGN: The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial. PARTICIPANTS: All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (<6 feet distance for >10min without face protection) Moderate exposure (<6 feet distance for >10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan). INTERVENTION AND COMPARATOR: In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan. MAIN OUTCOMES: Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14th day of randomization. RANDOMISATION: Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure. BLINDING (MASKING): Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 1000 participants will be enrolled in the study with 1:1 allocation. TRIAL STATUS: The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022. TRIAL REGISTRATION: Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

Efficacy and Safety of Direct Oral Anticoagulants Versus Vitamin K Antagonists in the Treatment of Left Ventricular Thrombus: A Systematic Review and Meta-analysis.

BACKGROUND: Left ventricular thrombus (LVT) may develop in systolic heart failure or after acute myocardial infarction. The current recommendations support the use of vitamin K antagonists (VKAs) for the treatment of LVT. Limited data exist regarding the use of direct oral anticoagulants (DOACs) in patients with LVT. This meta-analysis aims to investigate the efficacy and safety of DOACs versus VKAs for LVT. METHODS: We performed a comprehensive literature search using PubMed, Embase, and Cochrane Library databases through November 2020 for all studies that evaluated the efficacy and safety of DOACs versus VKAs in patients with LVT. The primary outcomes were LVT resolution, overall thromboembolic events, and thromboembolic stroke. The secondary outcomes were major bleeding and all-cause mortality. Pooled risk ratio (RR) and 95% confidence intervals (CIs) were obtained by the Mantel-Haenszel method within a random-effects model. Heterogeneity was assessed by I2 statistic. RESULTS: A total of 11 studies including 2153 patients with LVT on anticoagulation (570 on DOACs vs. 1583 on VKAs) were included. LVT resolution was significantly higher in DOACs compared with VKAs [RR: 1.18 (95% CI: 1.04-1.35); P = 0.01, I2 = 25%]. However, no significant difference existed between DOACs and VKAs regarding overall thromboembolic events [RR: 1.10 (95% CI: 0.75-1.62); P = 0.61, I2 = 0%] and thromboembolic stroke [RR: 0.63 (95% CI: 0.39-1.02); P = 0.06, I2 = 0%]. Major bleeding [RR: 1.00 (95% CI: 0.66-1.51); P = 0.99, I2 = 4%] and all-cause mortality [RR: 0.84 (95% CI: 0.50-1.43); P = 0.53, I2 = 0%] were similar between the 2 groups. CONCLUSIONS: DOACs seem to be more efficacious in achieving LVT resolution compared with VKAs. However, there was no significant difference between the 2 groups in thromboembolic events, major bleeding, and all-cause mortality. Randomized controlled trials are needed to confirm our findings.

Signet Cell in the Brain: A Case Report of Leptomeningeal Carcinomatosis as the Presenting Feature of Gastric Signet Cell Cancer.

Malignant infiltration of pia and arachnoid mater, referred to as leptomeningeal carcinomatosis (LMC), is a rare complication of gastric carcinoma. The most common underlying malignancy in patients with LMC are leukemia, breast cancer, lymphoma, and lung cancer. We report a case of gastric adenocarcinoma that presented with LMC in the absence of overt gastrointestinal signs or symptoms. A 56-year-old Hispanic woman presented to the hospital with a three-week history of intermittent headaches and visual blurring. An initial brain imaging showed infarction in the distribution of right posterior inferior cerebellar artery (PICA) along with communicating hydrocephalus. She underwent ventriculoperitoneal (VP) shunt placement with improvement in her symptoms. Two months later she presented again with deterioration in her mental status. Imaging studies and cerebrospinal fluid (CSF) analysis confirmed the diagnosis of LMC. Further studies determined the primary tumor to be signet ring cell gastric adenocarcinoma. However, she did not have any preceding gastrointestinal symptoms. In light of the poor prognosis, the patient's family proceeded with comfort care measures. Our case portrays a rare presentation of gastric adenocarcinoma with LMC without other distant organ metastatic involvement. It also illustrates the occult nature of gastric carcinoma and signifies the importance of neurologic assessment of patients, with or at risk of gastric carcinoma. â€‹It also raises a theoretical concern for VP shunt as a potential conduit of malignant cells from the abdomen to the central nervous system, which may serve as an important susbtrate for future research.

Development of a novel score to predict the risk of acute kidney injury in patient with acute myocardial infarction.

BACKGROUND: Acute kidney injury (AKI) is common in patients with acute myocardial infarction. AKI in this setting is associated with short- and long-term adverse events. The aim of this study was to develop a simple score to predict AKI in patients presenting with acute myocardial infarction based on data available at time of admission. METHODS: This was a retrospective analysis of data collected as part of the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) registry at a tertiary care center between 1/1/2011 and 12/31/2013. Data were collected prospectively for all patients who presented within 24 h of the onset of myocardial infarction. AKI was defined as an increase in creatinine from admission level to peak level of ≥0.3 mg/dl or by ≥50 %. Patients with history of end-stage renal disease requiring renal replacement therapy were excluded. RESULTS: Of 1107 patients included in the study, 147 (13.3 %) developed AKI. The following factors were independently associated with increased risk for AKI: cardiac arrest, decompensated heart failure on presentation, diabetes mellitus, hypertension, anemia, impaired renal function on presentation, and tachycardia on presentation. These factors were combined to form a new predictive tool. The new score showed excellent discrimination for AKI: the area under the receiver operating characteristic curve (AUROC) was 0.76 (95 % confidence interval 0.72-0.80). CONCLUSION: A simple score using clinical and laboratory data available on admission can predict the risk of AKI in patients presenting with acute myocardial infarction.