Noninvasive Ventilation in Critically Ill Patients With Severe Acute Respiratory Infections.

BACKGROUND: The objective of this study was to evaluate the association between noninvasive ventilation (NIV) compared with invasive ventilation and mortality in subjects with severe acute respiratory infection. METHODS: This was a retrospective multi-center study of subjects with severe acute respiratory infection treated with ventilatory support between September 2012 and June 2018. We compared the 90-d mortality of subjects managed initially with NIV (NIV group) with those managed with invasive ventilation only (invasive ventilation group), adjusting by propensity score. RESULTS: Of 383 subjects, 189 (49%) were in the NIV group and 194 (51%) were in the invasive ventilation group. Of the subjects initially treated with NIV, 117 (62%) were eventually intubated. Crude 90-d mortality was lower in the NIV group versus the invasive ventilation group (42 [22.2%] vs 77 [39.7%]; P < .001). After propensity score adjustment, NIV was associated with lower 90-d mortality than invasive ventilation (odds ratio 0.54, 95% CI 0.38-0.76; P < .001). The association of NIV with mortality compared with invasive ventilation was not different across the studied subgroups. CONCLUSIONS: In subjects with severe acute respiratory infection and acute respiratory failure, NIV was commonly used. NIV was associated with a lower 90-d mortality. The observed high failure rate suggests the need for further research to optimize patient selection and facilitate early recognition of NIV failure.

Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial.

BACKGROUND: The optimal amount and timing of protein intake in critically ill patients are unknown. REPLENISH (Replacing Protein via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial evaluates whether supplemental enteral protein added to standard enteral nutrition to achieve a high amount of enteral protein given from ICU day five until ICU discharge or ICU day 90 as compared to no supplemental enteral protein to achieve a moderate amount of enteral protein would reduce all-cause 90-day mortality in adult critically ill mechanically ventilated patients. METHODS: In this multicenter randomized trial, critically ill patients will be randomized to receive supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition to achieve a high amount of enteral protein (range of 2-2.4 g/kg/day) or no supplemental enteral protein to achieve a moderate amount of enteral protein (0.8-1.2 g/kg/day). The primary outcome is 90-day all-cause mortality; other outcomes include functional and health-related quality-of-life assessments at 90 days. The study sample size of 2502 patients will have 80% power to detect a 5% absolute risk reduction in 90-day mortality from 30 to 25%. Consistent with international guidelines, this statistical analysis plan specifies the methods for evaluating primary and secondary outcomes and subgroups. Applying this statistical analysis plan to the REPLENISH trial will facilitate unbiased analyses of clinical data. CONCLUSION: Ethics approval was obtained from the institutional review board, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia (RC19/414/R). Approvals were also obtained from the institutional review boards of each participating institution. Our findings will be disseminated in an international peer-reviewed journal and presented at relevant conferences and meetings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04475666 . Registered on July 17, 2020.

The Antiproliferative Activity of Adiantum pedatum Extract and/or Piceatannol in Phenylhydrazine-Induced Colon Cancer in Male Albino Rats: The miR-145 Expression of the PI-3K/Akt/p53 and Oct4/Sox2/Nanog Pathways.

Colon cancer is one of the most common types of cancer worldwide, and its incidence is increasing. Despite advances in medical science, the treatment of colon cancer still poses a significant challenge. This study aimed to investigate the potential protective effects of Adiantum pedatum (AP) extract and/or piceatannol on colon cancer induced via phenylhydrazine (PHZ) in terms of the antioxidant and apoptotic pathways and histopathologic changes in the colons of male albino rats. The rats were randomly divided into eight groups: control, AP extract, piceatannol (P), PHZ, PHZ and AP treatments, PHZ and P treatments, PHZ and both AP and P, and PHZ and prophylaxis with both AP and P. The results demonstrated that PHZ induced oxidative damage, apoptosis, and histopathological changes compared to the control group. However, the administration of AP or P or AP + P as therapy or prophylaxis significantly ameliorated these changes and upregulated the colonic mir-145 and mRNA expression of P53 and PDCD-4 while downregulating the colonic mRNA expression of PI3K, AKT, c-Myc, CK-20, SOX-2, OCT-4, and NanoG compared to the PHZ group. These findings suggest that the candidate drugs may exert their anti-cancer effects through multiple mechanisms, including antioxidant and apoptotic activities.

Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: the REPLENISH randomized clinical trial protocol.

BACKGROUND: Protein intake is recommended in critically ill patients to mitigate the negative effects of critical illness-induced catabolism and muscle wasting. However, the optimal dose of enteral protein remains unknown. We hypothesize that supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge or ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day) would reduce all-cause 90-day mortality in adult critically ill mechanically ventilated patients. METHODS: The REPLENISH (Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial is an open-label, multicenter randomized clinical trial. Patients will be randomized to the supplemental protein group or the control group. Patients in both groups will receive the primary enteral formula as per the treating team, which includes a maximum protein 1.2 g/kg/day. The supplemental protein group will receive, in addition, supplemental protein at 1.2 g/kg/day starting the fifth ICU day. The control group will receive the primary formula without supplemental protein. The primary outcome is 90-day all-cause mortality. Other outcomes include functional and quality of life assessments at 90 days. The trial will enroll 2502 patients. DISCUSSION: The study has been initiated in September 2021. Interim analysis is planned at one third and two thirds of the target sample size. The study is expected to be completed by the end of 2025. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04475666 . Registered on July 17, 2020.

Evidence-Based Interventions to Reduce the Incidence of Common Multidrug-Resistant Gram-Negative Bacteria in an Adult Intensive Care Unit.

Background Multidrug-resistant Gram-negative bacteria (MDR-GNB) present a significant and escalating hazard to healthcare globally. Context-specific interventions have been implemented for the prevention and control of MDR-GNB in several healthcare facilities. The objective of this study was to implement and evaluate the effectiveness of evidence-based interventions in the incidence and dissemination of MDR-GNB. Methods This was a pre-and post-intervention study conducted in three phases at King Abdulaziz Medical City Jeddah, Saudi Arabia. During Phase-1, the data on each of the four MDR-GNB (Acinetobacter baumannii, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Escherichia coli) were collected prospectively. Genomic fingerprinting was performed on isolates using enterobacterial repetitive intergenic consensus-polymerase chain reaction (ERIC-PCR) to determine clonality and establish a link between different strains within and between the hospital wards/units. In the second phase, targeted interventions were implemented in the adult intensive care unit (ICU) based on previously determined risk factors and included the education of healthcare workers on hand hygiene, disinfection of patients' surrounding, daily chlorhexidine baths, and disinfection rooms on discharge with hydrogen peroxide fogging after MDR-GNB patients were discharged. An antibiotic restriction protocol was simultaneously implemented as part of the hospital antibiotic stewardship program. In the third phase, the effectiveness of the interventions was evaluated by comparing the incidence rate and clonality (using ERIC-PCR genetic fingerprints) of MDR-GNB before and after the intervention. Results A significant reduction of MDR-GNB was observed in Phase-2 and Phase-3 compared with Phase-1. The mean incidence rate of MDR-GNB per 1000 patient days in Phase-1 (pre-intervention) was 11.08/1000, followed by 6.07 and 3.54/1000 in Phase-2 and Phase-3, respectively. A statistically significant reduction was observed in the incidence rate of MDR-GNB in the adult ICU (P=0.007), whereas no statistically significant decrease (P=0.419) was observed in areas other than the adult ICU. Two A. baumannii strains appear to be circulating within the ICU environment with reduced frequency in Phase-2 and Phase-3 compared to Phase-1. Conclusion  There was a significant reduction in the incidence of MDR-GNB in the adult ICU due to the successful implementation of both infection control and stewardship interventions, albeit challenging to ascertain the relative contribution of each.

Association of early mobility with the incidence of deep-vein thrombosis and mortality among critically ill patients: a post hoc analysis of PREVENT trial.

BACKGROUND: This study assessed the mobility levels among critically ill patients and the association of early mobility with incident proximal lower-limb deep-vein thrombosis and 90-day mortality. METHODS: This was a post hoc analysis of the multicenter PREVENT trial, which evaluated adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis with an expected ICU stay ≥ 72 h and found no effect on the primary outcome of incident proximal lower-limb deep-vein thrombosis. Mobility levels were documented daily up to day 28 in the ICU using a tool with an 8-point ordinal scale. We categorized patients according to mobility levels within the first 3 ICU days into three groups: early mobility level 4-7 (at least active standing), 1-3 (passive transfer from bed to chair or active sitting), and 0 (passive range of motion). We evaluated the association of early mobility and incident lower-limb deep-vein thrombosis and 90-day mortality by Cox proportional models adjusting for randomization and other co-variables. RESULTS: Of 1708 patients, only 85 (5.0%) had early mobility level 4-7 and 356 (20.8%) level 1-3, while 1267 (74.2%) had early mobility level 0. Patients with early mobility levels 4-7 and 1-3 had less illness severity, femoral central venous catheters, and organ support compared to patients with mobility level 0. Incident proximal lower-limb deep-vein thrombosis occurred in 1/85 (1.3%) patients in the early mobility 4-7 group, 7/348 (2.0%) patients in mobility 1-3 group, and 50/1230 (4.1%) patients in mobility 0 group. Compared with early mobility group 0, mobility groups 4-7 and 1-3 were not associated with differences in incident proximal lower-limb deep-vein thrombosis (adjusted hazard ratio [aHR] 1.19, 95% confidence interval [CI] 0.16, 8.90; p = 0.87 and 0.91, 95% CI 0.39, 2.12; p = 0.83, respectively). However, early mobility groups 4-7 and 1-3 had lower 90-day mortality (aHR 0.47, 95% CI 0.22, 1.01; p = 0.052, and 0.43, 95% CI 0.30, 0.62; p < 0.0001, respectively). CONCLUSIONS: Only a small proportion of critically ill patients with an expected ICU stay ≥ 72 h were mobilized early. Early mobility was associated with reduced mortality, but not with different incidence of deep-vein thrombosis. This association does not establish causality, and randomized controlled trials are required to assess whether and to what extent this association is modifiable. TRIAL REGISTRATION: The PREVENT trial is registered at ClinicalTrials.gov, ID: NCT02040103 (registered on 3 November 2013) and Current controlled trials, ID: ISRCTN44653506 (registered on 30 October 2013).

Impact of a national collaborative project to improve the care of mechanically ventilated patients.

This prospective quasi-experimental study from the NASAM (National Approach to Standardize and Improve Mechanical Ventilation) collaborative assessed the impact of evidence-based practices including subglottic suctioning, daily assessment for spontaneous awakening trial (SAT), spontaneous breathing trial (SBT), head of bed elevation, and avoidance of neuromuscular blockers unless otherwise indicated. The study outcomes included VAE (primary) and intensive care unit (ICU) mortality. Changes in daily care process measures and outcomes were evaluated using repeated measures mixed modeling. The results were reported as incident rate ratio (IRR) for each additional month with 95% confidence interval (CI). A comprehensive program that included education on evidence-based practices for optimal care of mechanically ventilated patients with real-time benchmarking of daily care process measures to drive improvement in forty-two ICUs from 26 hospitals in Saudi Arabia (>27,000 days of observation). Compliance with subglottic suctioning, SAT and SBT increased monthly during the project by 3.5%, 2.1% and 1.9%, respectively (IRR 1.035, 95%CI 1.007-1.064, p = 0.0148; 1.021, 95% CI 1.010-1.032, p = 0.0003; and 1.019, 95%CI 1.009-1.029, p = 0.0001, respectively). The use of neuromuscular blockers decreased monthly by 2.5% (IRR 0.975, 95%CI 0.953-0.998, p = 0.0341). The compliance with head of bed elevation was high at baseline and did not change over time. Based on data for 83153 ventilator days, VAE rate was 15.2/1000 ventilator day (95%CI 12.6-18.1) at baseline and did not change during the project (IRR 1.019, 95%CI 0.985-1.053, p = 0.2812). Based on data for 8523 patients; the mortality was 30.4% (95%CI 27.4-33.6) at baseline, and decreased monthly during the project by 1.6% (IRR 0.984, 95%CI 0.973-0.996, p = 0.0067). A national quality improvement collaborative was associated with improvements in daily care processes. These changes were associated with a reduction in mortality but not VAEs. Registration The study is registered in clinicaltrials.gov (NCT03790150).

Predictors of survival from Acinetobacter in Saudi Arabian intensive care units: A prospective, one-year, six-city, ten-center cohort study.

BACKGROUND: Antibiotic-resistant Acinetobacter baumannii is a continuously-emerging worldwide health crisis, with mortality rates approaching 50% in intensive care unit (ICU) patients. The objective of this study was to evaluate regional, patient-related, and organism-related predictors of survival among critically-ill patients with confirmed Acinetobacter infection. METHODS: This prospective cohort study was conducted within ten ICUs across six geographically- and climatologically-distinct cities across Saudi Arabia over 13 months. RESULTS: Of 169 patients with confirmed Acinetobacter infection enrolled in the study, 80 (47.6%) died. Survivors were statistically younger, predominantly male, more likely to be admitted for trauma, less likely to have hypertension, diabetes, or have undergone hemodialysis, and more likely to have been treated with antibiotics prior to having a positive culture for Acinetobacter, but less likely to have received an aminoglycoside. Survivors also had lower baseline APACHE II and SOFA scores and were infected with stains of Acinetobacter that had less meropenem- or colistin-resistance. Multivariate analysis identified the following independent predictors of survival: younger age, lower ICU-day#1 APACHE-II and ICU-day#3 SOFA scores, being admitted for trauma, and having no history of hemodialysis. CONCLUSIONS: Patient-related factors outweigh regional and hospital-related factors as predictors of survival among critically-ill patients with Acinetobacter infection.

The effect of intermittent pneumatic compression on deep-vein thrombosis and ventilation-free days in critically ill patients with heart failure.

There are contradictory data regarding the effect of intermittent pneumatic compression (IPC) on the incidence of deep-vein thrombosis (DVT) and heart failure (HF) decompensation in critically ill patients. This study evaluated the effect of adjunctive use of IPC on the rate of incident DVT and ventilation-free days among critically ill patients with HF. In this pre-specified secondary analysis of the PREVENT trial (N = 2003), we compared the effect of adjunctive IPC added to pharmacologic thromboprophylaxis (IPC group), with pharmacologic thromboprophylaxis alone (control group) in critically ill patients with HF. The presence of HF was determined by the treating teams according to local practices. Patients were stratified according to preserved (≥ 40%) versus reduced (< 40%) left ventricular ejection fraction, and by the New York Heart Association (NYHA) classification. The primary outcome was incident proximal lower-limb DVT, determined with twice weekly venous Doppler ultrasonography. As a co-primary outcome, we evaluated ventilation-free days as a surrogate for clinically important HF decompensation. Among 275 patients with HF, 18 (6.5%) patients had prevalent proximal lower-limb DVT (detected on trial day 1 to 3). Of 257 patients with no prevalent DVT, 11/125 (8.8%) patients in the IPC group developed incident proximal lower-limb DVT compared to 6/132 (4.5%) patients in the control group (relative risk, 1.94; 95% confidence interval, 0.74-5.08, p = 0.17). There was no significant difference in ventilator-free days between the IPC and control groups (median 21 days versus 25 days respectively, p = 0.17). The incidence of DVT with IPC versus control was not different across NYHA classes (p value for interaction = 0.18), nor across patients with reduced and preserved ejection fraction (p value for interaction = 0.15). Ventilator-free days with IPC versus control were also not different across NYHA classes nor across patients with reduced or preserved ejection fraction. In conclsuion, the use of adjunctive IPC compared with control was associated with similar rate of incident proximal lower-limb DVT and ventilator-free days in critically ill patients with HF.Trial registration: The PREVENT trial is registered at ClinicalTrials.gov, ID: NCT02040103 (registered on 3 November 2013, https://clinicaltrials.gov/ct2/show/study/NCT02040103 ) and Current controlled trials, ID: ISRCTN44653506 (registered on 30 October 2013).

Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial.

Importance: The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19. Objective: To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19. Design, Setting, and Participants: Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021. Intervention: Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195). Main Outcomes and Measures: The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events. Results: Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group. Conclusions and Relevance: In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT04350723.

Neuromorphic Architecture Accelerated Automated Seizure Detection in Multi-Channel Scalp EEG.

Epileptic focal seizures can be localized in the brain using tracer injections during or immediately after the incidence of a seizure. A real-time automated seizure detection system with minimal latency can help time the injection properly to find the seizure origin accurately. Reliable real-time seizure detection systems have not been clinically reported yet. We developed an anomaly detection-based automated seizure detection system, using scalp-electroencephalogram (EEG) data, which can be trained using a few seizure sessions, and implemented it on commercially available hardware with parallel, neuromorphic architecture-the NeuroStack. We extracted nonlinear, statistical, and discrete wavelet decomposition features, and we developed a graphical user interface and traditional feature selection methods to select the most discriminative features. We investigated Reduced Coulomb Energy (RCE) networks and K-Nearest Neighbors (k-NN) for its several advantages, such as fast learning no local minima problem. We obtained a maximum sensitivity of 91.14%±1.77% and a specificity of 98.77%±0.57% with 5 s epoch duration. The system's latency was 12 s, which is within most seizure event windows, which last for an average duration of 60 s. Our results showed that the CD feature consumes large computation resources and excluding it can reduce the latency to 3.6 s but at the cost of lower performance 80% sensitivity and 97% specificity. We demonstrated that the proposed methodology achieves a high specificity and an acceptable sensitivity within a short delay. Our results indicated also that individual-based RCE are superior to population-based RCE. The proposed RCE networks has been compared to SVM and ANN as a baseline for comparison as they are the most common machine learning seizure detection methods. SVM and ANN-based systems were trained on the same data as RCE and K-NN with features optimized specifically for them. RCE nets are superior to SVM and ANN. The proposed model also achieves comparable performance to the state-of-the-art deep learning techniques while not requiring a sizeable database, which is often expensive to build. These numbers indicate that the system is viable as a trigger mechanism for tracer injection.

The Saudi Critical Care Society practice guidelines on the management of COVID-19 in the ICU: Therapy section.

BACKGROUND: The rapid increase in coronavirus disease 2019 (COVID-19) cases during the subsequent waves in Saudi Arabia and other countries prompted the Saudi Critical Care Society (SCCS) to put together a panel of experts to issue evidence-based recommendations for the management of COVID-19 in the intensive care unit (ICU). METHODS: The SCCS COVID-19 panel included 51 experts with expertise in critical care, respirology, infectious disease, epidemiology, emergency medicine, clinical pharmacy, nursing, respiratory therapy, methodology, and health policy. All members completed an electronic conflict of interest disclosure form. The panel addressed 9 questions that are related to the therapy of COVID-19 in the ICU. We identified relevant systematic reviews and clinical trials, then used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach as well as the evidence-to-decision framework (EtD) to assess the quality of evidence and generate recommendations. RESULTS: The SCCS COVID-19 panel issued 12 recommendations on pharmacotherapeutic interventions (immunomodulators, antiviral agents, and anticoagulants) for severe and critical COVID-19, of which 3 were strong recommendations and 9 were weak recommendations. CONCLUSION: The SCCS COVID-19 panel used the GRADE approach to formulate recommendations on therapy for COVID-19 in the ICU. The EtD framework allows adaptation of these recommendations in different contexts. The SCCS guideline committee will update recommendations as new evidence becomes available.

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial.

BACKGROUND: To evaluate the effect of screening for sepsis using an electronic sepsis alert vs. no alert in hospitalized ward patients on 90-day in-hospital mortality. METHODS: The SCREEN trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 45 wards, constituting clusters in this design) are randomized to have active alert vs. masked alert, 5 wards at a time, with each 5 wards constituting a sequence. The study consists of ten 2-month periods with a phased introduction of the intervention. In the first period, all wards have a masked alert for 2 months. Afterwards the intervention (alert system) is implemented in a new sequence every 2-month period until the intervention is implemented in all sequences. The intervention includes the implementation of an electronic alert system developed in the hospital electronic medical records based on the quick sequential organ failure assessment (qSOFA). The alert system sends notifications of "possible sepsis alert" to the bedside nurse, charge nurse, and primary medical team and requires an acknowledgment in the health information system from the bedside nurse and physician. The calculated sample size is 65,250. The primary endpoint is in-hospital mortality by 90 days. DISCUSSION: The trial started on October 1, 2019, and is expected to complete patient follow-up by the end of October 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019.

Incidence, outcomes, and predictors of Acinetobacter infection in Saudi Arabian critical care units.

BACKGROUND: Acinetobacter is an increasingly-problematic organism, especially in intensive care units (ICUs). In this study, we compared its incidence, outcomes, and predictors spanning eight ICUs in five geographically and climatologically-diverse cities in Saudi Arabia. METHODS: Geographic, climatologic, hospital-related, and patient-related factors were collected prospectively on 3179 patients admitted to eight Saudi ICUs from June 2018 through June 2019. These data then underwent both bivariable and multivariable analysis, the latter vis hierarchical logistic regression to identify predictors of clinically-manifest Acinetobacter infection. RESULTS: Overall incidence of Acinetobacter infection was 3.9% (n = 124). Of these 124 infections, 122 (98.4%) were cultured as A. baumannii. Incidence ranged from 1.0 to 7.9% across the eight ICUs. On bivariable analysis, incident Acinetobacter infection was more common in university and military hospitals, in hospitals with more total beds and ICU isolation rooms, and in 2018 versus 2019, incidence steadily declining over the 13 study months. Mechanically-ventilated patients had ten-fold increased odds of infection. Adjusted (multivariable) analysis revealed the risk of clinically-manifest Acinetobacter infection to increase the longer patients were on mechanical ventilation. Increased risk also existed at certain hospitals over others, especially in university-affiliated and military hospitals, larger hospitals with more isolation rooms, and hospitals with fewer ICU beds. CONCLUSION: In our study of eight ICUs across Saudi Arabia, inter-hospital differences did appear to account for inter-hospital differences in Acinetobacter incidence rates. Patients requiring mechanical ventilation for longer periods of time were particularly at risk.

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Non-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality. METHODS AND ANALYSIS: This is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. ETHICS AND DISSEMINATION: Approvals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings. TRIAL REGISTRATION NUMBER: NCT04477668.

Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): study protocol for a multicenter randomized controlled trial

IntroductionNoninvasive ventilation delivered by helmet is has been used for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. The aim of this study is to compare helmet noninvasive ventilation with usual care versus usual care alone to reduce the mortality. Methods and analysisThis is a multicenter, pragmatic, parallel, randomized controlled trial that compares helmet noninvasive ventilation with usual care to usual care alone in 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. Ethics and disseminationApprovals are obtained from the Institutional Review Boards (IRBs) of each participating institution. Our findings will be published in peer-review journals and presented at relevant conferences and meetings. Trial registration numberNCT04477668 registered on July 20, 2020 Article SummaryO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LIThis trial compares helmet NIV to usual care for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. C_LIO_LIThe trial is a multi-center, pragmatic, parallel randomized controlled trial. C_LIO_LIThe main limitation is the unblinded design due to the nature of the intervention. C_LI

Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: A pilot randomized controlled trial (REPLENISH pilot trial).

BACKGROUND AND AIMS: The optimal amount of protein intake in critically ill patients is unclear. The objective of this pilot trial is to assess the feasibility of a large randomized controlled trial testing higher versus lower protein intake in critically ill patients. METHODS: In this pilot randomized controlled trial (REPLacing Protein via Enteral Nutrition in a Stepwise ApproacH in critically ill patients: A pilot randomized controlled trial (REPLENISH pilot trial), critically ill patients underwent 2-step screening for eligibility on ICU day 1 and 5. Patients with renal disease were excluded. Eligible patients were randomized into REPLENISH group (target protein 1.8-2.2 g kg/day) and Standard group (target protein 0.8-1.0 g/kg/day) from day 6-14 after ICU admission. Dietitians adjusted caloric and protein intake throughout the study period (Day 1-14) to maintain similar caloric targets of permissive underfeeding (40-60% of estimated energy expenditure) in both study groups. RESULTS: Of 704 patients screened at 3 centers in Saudi Arabia from May 2018 to May 2019, only 63 (8.9%) were eligible and 40 (5.7% of screened) were randomized with an average of 2 patients enrolled in the trial per month. Among eligible patients, the consenting rate was high at 89%. During the intervention period, patients in the REPLENISH group (N = 21) had a modestly higher protein intake (median of 1.30 g/kg/day (Q1 Q3: 1.11, 1.57)) than those in the standard group (median of 0.77 g/kg/day (Q1 Q3: 0.57, 1.00); P = 0.0004). Only 31.4% of patients in the whole cohort had >80% of prescribed protein. The duration of daily interruption of feeding was almost 4 h in both groups. The 90-day mortality for the patient study cohort was 20.5%. Anthropometric and muscle strength measurements were performed in less than 50% of patients. CONCLUSIONS: This pilot trial highlighted several areas for improvement in the study protocol before launching a large randomized controlled trial. The restrictive eligibility criteria, the complex adjustments of protein and energy and some of the outcome measurements were identified as targets for modifications, to improve enrollment and generalizability and to enhance adherence to study interventions and measurements. TRIAL REGISTRATION: CLINICALTRIALS. GOV IDENTIFIER: NCT03480555.

Spilled stones following pyelolithotomy: An unusual mimic of peritoneal carcinomatosis.

While spillage of intraperitoneal gallstones has been reported frequently in the literature, spilled renal stones after urologic intervention is rare. The dropped renal stones may mimic peritoneal carcinomatosis (PC) on imaging, causing concern and potentially leading to unnecessary diagnostic workup. Additionally, these dropped stones may cause surrounding inflammation, potentially leading to the formation of adhesions or an intra-abdominal abscess. Calcifications along the peritoneal lining are generally interpreted as peritoneal carcinomatosis until proven otherwise. However, this case highlights the importance of a detailed history and comparison with prior imaging. We describe a rare case of intraperitoneal spilled renal stones after pyelolithotomy initially mistaken for PC, in addition to a review of diagnostic pitfalls and radiologic mimics of PC.

Asymptomatic pneumoperitoneum in the setting of pneumatosis intestinalis: a benign entity or surgical emergency?

Pneumatosis intestinalis is a potential cause of asymptomatic pneumoperitoneum without peritonitis. The disease can be managed conservatively and presents a clinical scenario where pneumoperitoneum does not necessitate surgical management. This case illustrates the importance of acknowledging the condition and its variable presentation, allowing for increased awareness and avoidance of invasive procedures when not indicated.

Critically ill patients with diabetes and Middle East respiratory syndrome: a multi-center observational study.

BACKGROUND: Diabetes is a risk factor for infection with coronaviruses. This study describes the demographic, clinical data, and outcomes of critically ill patients with diabetes and Middle East Respiratory Syndrome (MERS). METHODS: This retrospective cohort study was conducted at 14 hospitals in Saudi Arabia (September 2012-January 2018). We compared the demographic characteristics, underlying medical conditions, presenting symptoms and signs, management and clinical course, and outcomes of critically ill patients with MERS who had diabetes compared to those with no diabetes. Multivariable logistic regression analysis was performed to determine if diabetes was an independent predictor of 90-day mortality. RESULTS: Of the 350 critically ill patients with MERS, 171 (48.9%) had diabetes. Patients with diabetes were more likely to be older, and have comorbid conditions, compared to patients with no diabetes. They were more likely to present with respiratory failure requiring intubation, vasopressors, and corticosteroids. The median time to clearance of MERS-CoV RNA was similar (23 days (Q1, Q3: 17, 36) in patients with diabetes and 21.0 days (Q1, Q3: 10, 33) in patients with no diabetes). Mortality at 90 days was higher in patients with diabetes (78.9% versus 54.7%, p < 0.0001). Multivariable regression analysis showed that diabetes was an independent risk factor for 90-day mortality (odds ratio, 2.09; 95% confidence interval, 1.18-3.72). CONCLUSIONS: Half of the critically ill patients with MERS have diabetes; which is associated with more severe disease. Diabetes is an independent predictor of mortality among critically patients with MERS.