Clinical Care Pathway and Management of Major Bleeding Associated with Nonvitamin K Antagonist Oral Anticoagulants: A Modified Delphi Consensus from Saudi Arabia and UAE.

Background: The nonvitamin K antagonist oral anticoagulants (NOACs) have become the mainstay anticoagulation therapy for patients requiring oral anticoagulants (OACs) in the Gulf Council Cooperation (GCC) countries. The frequency of NOAC-associated major bleeding is expected to increase in the Emergency Department (ED). Nonetheless, we still lack local guidelines and recommendations for bleeding management in the region. The present Delphi-based consensus aims to establish a standardized and evidence-based clinical care pathway for managing NOAC-associated major bleeding in the Kingdom of Saudi Arabia (KSA) and the United Arab Emirates (UAE). Methods: We adopted a three-step modified Delphi method to develop evidence-based recommendations through two voting rounds and an advisory meeting between the two rounds. A panel of 11 experts from the KSA and UAE participated in the consensus development. Results: Twenty-eight statements reached the consensus level. These statements addressed key aspects of managing major bleeding events associated with NOACs, including the increased use of NOAC in clinical practice, clinical care pathways, and treatment options. Conclusion: The present Delphi consensus provides evidence-based recommendations and protocols for the management of NOAC-associated bleeding in the region. Patients with major DOAC-induced bleeding should be referred to a well-equipped ED with standardized management protocols. A multidisciplinary approach is recommended for establishing the association between NOAC use and major bleeding. Treating physicians should have prompt access to specific reversal agents to optimize patient outcomes. Real-world evidence and national guidelines are needed to aid all stakeholders involved in NOAC-induced bleeding management.

Effects of a team Quality Improvement method in a national clinical audit programme of four clinical specialties in Ministry of Health hospitals in Saudi Arabia.

In 2018, the Ministry of Health (MoH) in Saudi Arabia developed a clinical excellence strategy. An objective was to reduce variation in clinical practices in MoH hospitals, particularly for conditions with high mortality in Saudi Arabia, by applying best practice clinical standards and using the clinical audit process to measure clinical practice. The strategy included working with multiprofessional teams in hospitals to implement improvements needed in clinical practice. To test the feasibility of carrying out national clinical audits in MoH hospitals, audits were carried out in 16 MoH hospitals on four clinical subjects-acute myocardial infarction, major trauma, sepsis, and stroke. Clinical expert groups, including Saudi clinicians and an international clinical expert, developed clinical care standards for the four conditions from analyses of international and Saudi clinical guidelines. The audits were designed with the expert groups. Multiprofessional teams were appointed to carry out the audits in designated MoH hospitals. Data collectors in each hospital were trained to collect data. Workshops were held with the teams on the clinical care standards and how data would be collected for the audits, and later, on the findings of data collection and how to use the improvement process to implement changes to improve compliance with the standards. After 4 months, data collection was repeated to determine if compliance with the clinical care standards had improved. Data collected from each hospital for both cycles of data collection were independently reliably tested. All designated hospitals participated in the audits, collecting and submitting data for two rounds of data collection and implementing improvement plans after the first round of data collection. All hospitals made substantial improvements in clinical practices. Of a total of 84 measures used to assess compliance with a total of 52 clinical care standards for the four clinical conditions, improvements were made by hospital teams in 58 (69.1%) measures. Improvements were statistically significant for 34 (40.5%) measures. The project demonstrated that well-designed and executed audits using evidence-based clinical care standards can result in substantial improvements in clinical practices in MoH hospitals in Saudi Arabia. Keys to success were the improvement methodology built into the audit process and the requirement for hospitals to appoint multiprofessional teams to carry out the audits. The approach adds to evidence on the effectiveness of clinical audits in achieving improvements in clinical quality and can be replicated in national audit programmes.

The advantages of inhalational sedation using an anesthetic-conserving device versus intravenous sedatives in an intensive care unit setting: A systematic review.

BACKGROUND: Sedation is fundamental to the management of patients in the intensive care unit (ICU). Its indications in the ICU are vast, including the facilitating of mechanical ventilation, permitting invasive procedures, and managing anxiety and agitation. Inhaled sedation with halogenated agents, such as isoflurane or sevoflurane, is now feasible in ICU patients using dedicated devices/systems. Its use may reduce adverse events and improve ICU outcomes compared to conventional intravenous (IV) sedation in the ICU. This review examined the effectiveness of inhalational sedation using the anesthetic conserving device (ACD) compared to standard IV sedation for adult patients in ICU and highlights the technical aspects of its functioning. METHODS: We searched the PubMed, Cochrane Central Register of Controlled Trials, The Cochrane Library, MEDLINE, Web of Science, and Sage Journals databases using the terms "anesthetic conserving device," "Anaconda," "sedation" and "intensive care unit" in randomized clinical studies that were performed between 2012 and 2022 and compared volatile sedation using an ACD with IV sedation in terms of time to extubation, duration of mechanical ventilation, and lengths of ICU and hospital stay. RESULTS: Nine trials were included. Volatile sedation (sevoflurane or isoflurane) administered through an ACD shortened the awakening time compared to IV sedation (midazolam or propofol). CONCLUSION: Compared to IV sedation, volatile sedation administered through an ACD in the ICU shortened the awakening and extubation times, ICU length of stay, and duration of mechanical ventilation. More clinical trials that assess additional clinical outcomes on a large scale are needed.

Evidence-based Management of Major Bleeding in Patients Receiving Direct Oral Anticoagulants: An Updated Narrative Review on the Role of Specific Reversal Agents.

The indications of direct oral anticoagulants (DOACs) have expanded over the past 15 years. DOACs are effective and safe oral anticoagulants associated with lower bleeding risks and mortality than vitamin K antagonists. However, DOAC users are prone to a considerable bleeding risk, which can occur at critical sites or lead to severe life-threatening conditions. Recent statistics indicated that major bleeding occurs in up to 6.62 DOAC users per 100 treatment years. With the increased use of DOACs in clinical practice, DOAC-associated major bleeding is expected to be encountered more frequently in the emergency department. The current international guidelines recommend specific reversal agents for the management of DOAC users with severe bleeding to reverse the anticoagulant effect and restore normal hemostasis. An individualized assessment was incorporated in specific clinical situations to guide the decision pathway of major bleeding management. However, specific reversal agents are unavailable or have limited availability in many countries, which is expected to negatively impact the clinical outcomes of DOAC-associated major bleeding. Limited real-world evidence is available from these countries regarding the clinical outcomes of patients with DOAC-associated major bleeding. This narrative review provided an updated assessment of the evidence-based approaches for the management of major bleeding in DOAC users. We also explored the clinical outcomes of patients with major bleeding from clinical settings where specific reversal agents are unavailable.

The Prevalence of Simultaneously Ordering Amylase and Lipase for Diagnosing Pancreatitis.

Background: The simultaneous measurement of serum amylase and lipase levels in the diagnosis of pancreatitis was deemed unnecessary in several studies. We aim at evaluating the prevalence of the simultaneous co-ordering of serum amylase and lipase. Methods: This retrospective chart review was conducted at King Saud University Medical City in Riyadh, Saudi Arabia, between January 2021 and January 2022. We examined requests for serum amylase or serum lipase levels that had been sought for suspected pancreatitis within the electronic health system (EHS). Results: A total of 9,617 requests for serum amylase and serum lipase levels for 5,536 patients were made in a year; 6,873 (71.5%) were made for serum lipase alone; 1,672 (17.4%) were made for co-ordered serum lipase and amylase; 322 (3.3%) were made for amylase alone; and 750 (7.8%) were made for repeated amylase testing. Four hundred and thirteen tests (4.3%) yielded a diagnosis of pancreatitis. The estimated cost reduction when serum amylase was removed if serum lipase was co-ordered was 108,680 SAR (approximately US$28,960). Conclusion: Serum amylase and lipase were co-ordered for about 17.4% of pancreatitis diagnostic tests, all of which were unnecessary. Eliminating serum amylase testing for any patient who receives a test of their lipase levels would exert a significant impact on institutional costs and savings.

Realistic simulation case scenario as a vertical integration teaching tool for medical students: A mixed methods study.

Realistic simulation-based learning has recently become an integral part of medical education and can provide several advantages if applied effectively. This study aimed to develop and validate a realistic simulation case scenario (RSCS) as a novel teaching tool for preclinical medical students. Furthermore, we aimed to evaluate student perception of this tool as a teaching strategy, as well as to acquire an in-depth understanding of student perspectives. We employed the mixed methods approach to explore how clinical reasoning develops through a validated RSCS. This study, which included 50 third-year medical students, was conducted at the College of Medicine, Dar Al Uloom University, KSA between November 2021 and February 2022. Most of the participants (94%) were satisfied with the RSCS method and 92% of the participants reported RSCS as more effective in terms of achieving learning objectives. Many advantages of RSCS have been reported, including the provision of realistic knowledge relating to critical care management, encouraging student participation in the learning process, and enhancing interpersonal and problem-solving skills. In conclusion, RSCS is an effective and dynamic teaching approach that aids in knowledge consolidation with a significant impact on the emotions and cognitive abilities of students.

Tocilizumab Outcomes in Critically Ill COVID-19 Patients Admitted to the ICU and the Role of Non-Tocilizumab COVID-19-Specific Medical Therapeutics.

BACKGROUND: Tocilizumab is a monoclonal antibody proposed to manage cytokine release syndrome (CRS) associated with severe COVID-19. Previously published reports have shown that tocilizumab may improve the clinical outcomes of critically ill patients admitted to the ICU. However, no precise data about the role of other medical therapeutics concurrently used for COVID-19 on this outcome have been published. OBJECTIVES: We aimed to compare the overall outcome of critically ill COVID-19 patients admitted to the ICU who received tocilizumab with the outcome of matched patients who did not receive tocilizumab while controlling for other confounders, including medical therapeutics for critically ill patients admitted to ICUs. METHODS: A prospective, observational, multicenter cohort study was conducted among critically ill COVID-19 patients admitted to the ICU of 14 hospitals in Saudi Arabia between 1 March 2020, and October 31, 2020. Propensity-score matching was utilized to compare patients who received tocilizumab to patients who did not. In addition, the log-rank test was used to compare the 28 day hospital survival of patients who received tocilizumab with those who did not. Then, a multivariate logistic regression analysis of the matched groups was performed to evaluate the impact of the remaining concurrent medical therapeutics that could not be excluded via matching 28 day hospital survival rates. The primary outcome measure was patients' overall 28 day hospital survival, and the secondary outcomes were ICU length of stay and ICU survival to hospital discharge. RESULTS: A total of 1470 unmatched patients were included, of whom 426 received tocilizumab. The total number of propensity-matched patients was 1278. Overall, 28 day hospital survival revealed a significant difference between the unmatched non-tocilizumab group (586; 56.1%) and the tocilizumab group (269; 63.1%) (p-value = 0.016), and this difference increased even more in the propensity-matched analysis between the non-tocilizumab group (466.7; 54.6%) and the tocilizumab group (269; 63.1%) (p-value = 0.005). The matching model successfully matched the two groups' common medical therapeutics used to treat COVID-19. Two medical therapeutics remained significantly different, favoring the tocilizumab group. A multivariate logistic regression was performed for the 28 day hospital survival in the propensity-matched patients. It showed that neither steroids (OR: 1.07 (95% CI: 0.75-1.53)) (p = 0.697) nor favipiravir (OR: 1.08 (95% CI: 0.61-1.9)) (p = 0.799) remained as a predictor for an increase in 28 day survival. CONCLUSION: The tocilizumab treatment in critically ill COVID-19 patients admitted to the ICU improved the overall 28 day hospital survival, which might not be influenced by the concurrent use of other COVID-19 medical therapeutics, although further research is needed to confirm this.

Long-term outcomes of patients with COVID-19 treated with helmet noninvasive ventilation or usual respiratory support: follow-up study of the Helmet-COVID randomized clinical trial.

PURPOSE: To evaluate whether helmet noninvasive ventilation compared to usual respiratory support reduces 180-day mortality and improves health-related quality of life (HRQoL) in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. METHODS: This is a pre-planned follow-up study of the Helmet-COVID trial. In this multicenter, randomized clinical trial, adults with acute hypoxemic respiratory failure (n = 320) due to coronavirus disease 2019 (COVID-19) were randomized to receive helmet noninvasive ventilation or usual respiratory support. The modified intention-to-treat population consisted of all enrolled patients except three who were lost at follow-up. The study outcomes were 180-day mortality, EuroQoL (EQ)-5D-5L index values, and EQ-visual analog scale (EQ-VAS). In the modified intention-to-treat analysis, non-survivors were assigned a value of 0 for EQ-5D-5L and EQ-VAS. RESULTS: Within 180 days, 63/159 patients (39.6%) died in the helmet noninvasive ventilation group compared to 65/158 patients (41.1%) in the usual respiratory support group (risk difference - 1.5% (95% confidence interval [CI] - 12.3, 9.3, p = 0.78). In the modified intention-to-treat analysis, patients in the helmet noninvasive ventilation and the usual respiratory support groups did not differ in EQ-5D-5L index values (median 0.68 [IQR 0.00, 1.00], compared to 0.67 [IQR 0.00, 1.00], median difference 0.00 [95% CI - 0.32, 0.32; p = 0.91]) or EQ-VAS scores (median 70 [IQR 0, 93], compared to 70 [IQR 0, 90], median difference 0.00 (95% CI - 31.92, 31.92; p = 0.55). CONCLUSIONS: Helmet noninvasive ventilation did not reduce 180-day mortality or improve HRQoL compared to usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.

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).

Accuracy of Brain Computed Tomography Diagnosis by Emergency Medicine Physicians.

Objectives: The objective of this study is to prospectively analyze emergency physicians' (EP's) abilities to interpret noncontrast computed tomography (NCCT) brain images in a blinded fashion and assess whether they can make medical decisions solely based on their interpretations. Methods: A cross-sectional study was conducted at the emergency department (ED), King Saud University Medical City (KSU-MC), Saudi Arabia, over a period of one year, from May 2014 to May 2015. Any patient who underwent plain brain NCCT during the study period in our ED was included in this study. An independent attending neuroradiologist compared the EP's interpretations with the official final reports dictated by an on-call radiologist. Results: A brain NCCT prospective chart audit of 1,524 patients was interpreted by ED physicians (EP) at KSU-MC from 2014-2015. The ages of patients were between 14 and 107 years, and the mean ± SD age was 45.6 ± 22.1 years. Radiological brain lesions were confirmed by EPs and radiology physicians in 230 (15.09) and 239 (15.68) patients, respectively, out of which concordance was observed in 170 (71.13) cases, with a kappa value of r = 0.675. Normal, chronic, and nil acute reports were made by EPs and radiology physicians for 1,295 (84.97) patients and 1,285 (84.32) patients, respectively, out of which concordance was observed in 1,225 (95.33) cases, with a kappa value of r = 0.672. The study results demonstrated that the overall agreement between EPs and radiologist specialists was 91.6, with a kappa value of .675 (p < 0.001). Conclusion: Emergency physicians are moderately accurate at interpreting brain NCCT compared to radiologists. More research is needed to discover the most cost-effective technique for reducing the number of significant misinterpretations.

Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19: The HELMET-COVID Randomized Clinical Trial.

Importance: Helmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited. Objective: To evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. Design, Setting, and Participants: This was a multicenter, pragmatic, randomized clinical trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n = 320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021. Interventions: Patients were randomized to receive helmet noninvasive ventilation (n = 159) or usual respiratory support (n = 161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen. Main Outcomes and Measures: The primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation, barotrauma, skin pressure injury, and serious adverse events. Results: Among 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, -8.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49]; P = .85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, -3.1% [95% CI, -14.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points. Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group. Conclusions and Relevance: Results of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm. Trial Registration: ClinicalTrials.gov Identifier: NCT04477668.

Knowledge and Behavior toward Venous Thromboembolism Event Prophylaxis and Treatment Protocols among Medical Interns in Riyadh.

Objective: This study was aimed at evaluating the knowledge and behavior toward venous thromboembolism (VTE) prophylaxis among medical interns. Methods: This is a questionnaire-based cross-sectional observational cohort study of medical interns that used a validated questionnaire. The questionnaire comprised of items that assessed behavior, knowledge, and self-assessment of VTE risk factors, diagnosis, and prophylaxis. The study was conducted in Riyadh, Saudi Arabia, from October 2020 till September 2021. Results: The respondents were 246 medical interns. The overall rate of correct responses to behavior items was 41.82%. The overall rate of correct responses to knowledge items was 47.35%. A total of 61.8% responded negatively to the use of VTE risk assessment guidelines (p < 0.0001). For the self-assessment of knowledge of VTE, more than 70% believed they did not have appropriate knowledge, were not prepared to establish the risk of VTE, and were not prepared to provide adequate prophylaxis for VTE (p < 0.0001). A high proportion of medical interns (83.3%, p < 0.0001) believed they needed further training on this topic. Conclusion: Participants in this study showed poor knowledge and negative behavior regarding the assessment of risk factors, diagnosis, and prophylaxis of VTE. The majority of participants reported they needed training on this topic. These findings underscore the need for educational programs during undergraduate training and orientation of medical interns for VTE risk assessment, diagnosis, and prophylaxis at the beginning of their internship.

Machine learning decision tree algorithm role for predicting mortality in critically ill adult COVID-19 patients admitted to the ICU.

BACKGROUND: Coronavirus disease-19 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is currently a major cause of intensive care unit (ICU) admissions globally. The role of machine learning in the ICU is evolving but currently limited to diagnostic and prognostic values. A decision tree (DT) algorithm is a simple and intuitive machine learning method that provides sequential nonlinear analysis of variables. It is simple and might be a valuable tool for bedside physicians during COVID-19 to predict ICU outcomes and help in critical decision-making like end-of-life decisions and bed allocation in the event of limited ICU bed capacities. Herein, we utilized a machine learning DT algorithm to describe the association of a predefined set of variables and 28-day ICU outcome in adult COVID-19 patients admitted to the ICU. We highlight the value of utilizing a machine learning DT algorithm in the ICU at the time of a COVID-19 pandemic. METHODS: This was a prospective and multicenter cohort study involving 14 hospitals in Saudi Arabia. We included critically ill COVID-19 patients admitted to the ICU between March 1, 2020, and October 31, 2020. The predictors of 28-day ICU mortality were identified using two predictive models: conventional logistic regression and DT analyses. RESULTS: There were 1468 critically ill COVID-19 patients included in the study. The 28-day ICU mortality was 540 (36.8 %), and the 90-day mortality was 600 (40.9 %). The DT algorithm identified five variables that were integrated into the algorithm to predict 28-day ICU outcomes: need for intubation, need for vasopressors, age, gender, and PaO2/FiO2 ratio. CONCLUSION: DT is a simple tool that might be utilized in the ICU to identify critically ill COVID-19 patients who are at high risk of 28-day ICU mortality. However, further studies and external validation are still required.

Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial.

BACKGROUND: Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation has multiple advantages over other oxygen support modalities but data about effectiveness are limited. METHODS: In this multicenter randomized trial of helmet noninvasive ventilation for COVID-19 patients, 320 adult ICU patients (aged ≥14 years or as per local standards) with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (ratio of arterial oxygen partial pressure to fraction of inspired oxygen < 200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate of 10 L/min or higher) will be randomized to helmet noninvasive ventilation with usual care or usual care alone, which may include mask noninvasive ventilation, high-flow nasal oxygen, or standard oxygen therapy. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction in 28-day mortality from 40 to 25%. The primary outcome will be compared between the helmet and usual care group in the intention-to-treat using the chi-square test. Results will be reported as relative risk  and 95% confidence interval. The first patient was enrolled on February 8, 2021. As of August 1, 2021, 252 patients have been enrolled from 7 centers in Saudi Arabia and Kuwait. DISCUSSION: We developed a detailed statistical analysis plan to guide the analysis of the Helmet-COVID trial, which is expected to conclude enrollment in November 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04477668 . Registered on July 20, 2020.

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.

Knowledge of non-healthcare individuals towards cardiopulmonary resuscitation: a cross-sectional study in Riyadh City, Saudi Arabia.

BACKGROUND: Most sudden cardiac arrests occur at home, with low rates of bystander cardiopulmonary resuscitation being performed. We aimed to assess knowledge of cardiopulmonary resuscitation among individuals in Riyadh City, Saudi Arabia, who are not involved in health care. METHODS: A community-based cross-sectional study was conducted between January and February 2020 in 4 different areas in Riyadh City: North, South, East, and West. The participants were surveyed using a validated self-administered questionnaire. The Statistical Package for Social Sciences version 25.0 was used for inferential statistics and binary logistic regression analysis. RESULTS: A total of 856 participants completed the questionnaire, 51.8% were unaware of cardiopulmonary resuscitation. Only 4.4% of the participants had attended a formal cardiopulmonary resuscitation training course, 5.1% were campaign attendees, and 38.7% acquired their experience through the media. Having a higher level of education was positively associated with having knowledge of cardiopulmonary resuscitation. The main concern among attendees of cardiopulmonary resuscitation training courses and campaigns was legal issues, whereas inadequate knowledge was the major barrier for those who had learned about cardiopulmonary resuscitation through the media. CONCLUSION: The level of knowledge of cardiopulmonary resuscitation among non-health care individuals in Riyadh City was found to be insufficient. Therefore, coordinated efforts among different authorities should be considered to implement a structured strategy aiming to increase awareness and knowledge of cardiopulmonary resuscitation among non-health care individuals.

Implementing and Optimizing Inpatient Access to Dermatology Consultations via Telemedicine: An Experiential Study.

Background/Introduction: In-house dermatology consultation services for hospitalized patients are not universally available in acute care hospitals. We encountered an unanticipated access gap for in-person dermatology consultations in our tertiary care hospital that routinely cares for complex high acuity patients with multiple comorbidities. To bridge this gap in specialist expertise in a timely manner, we expeditiously designed and implemented a telemedicine-supported inpatient dermatology consultation service. Methods: We conducted a retrospective review of 155 teledermatology consultations conducted between November 2017 and March 2019 as well as periodic prospective multidisciplinary process improvement meetings to optimize service-associated process maps and workflows. Results: Teledermatology consultations changed the working diagnosis of the primary team in 52.3% of cases and most commonly recommended medical management (61.9% of cases). In total 100% of patients accepted telemedicine support and rated their experience as positive. The first three periodic process improvement meetings led to significant improvements in teledermatology-related process maps and workflows. Discussion: Diagnostic concordance rates between the primary team and the teledermatologist were similar to those reported in the literature for in-person dermatology consultations. Important process improvements include establishing central responsibility of preparing and overseeing the consultation process, mandating the presence of a primary team representative during consultation and patient chart review by the teledermatologist before teleconsultation. Conclusion: Inpatient teledermatology consultation services can be instituted timely and continuously improved to reliably and effectively bridge access gaps, improve diagnostic accuracy and differentiate therapeutic approaches while maintaining patient satisfaction.

Effects of Telemedicine ICU Intervention on Care Standardization and Patient Outcomes: An Observational Study.

OBJECTIVES: Given the numerous recent changes in ICU practices and protocols, we sought to confirm whether favorable effects of telemedicine ICU interventions on ICU mortality and length of stay can be replicated by a more recent telemedicine ICU intervention. DESIGN SETTING AND PATIENTS: Observational before-after telemedicine ICU intervention study in seven adult ICUs in two hospitals. The study included 1,403 patients in the preintervention period (October 2014 to September 2015) and 14,874 patients in the postintervention period (January 2016 to December 2018). INTERVENTION: Telemedicine ICU implementation. MEASUREMENTS AND MAIN RESULTS: ICU and hospital mortality and length of stay, best practice adherence rates, and telemedicine ICU performance metrics. Unadjusted ICU and hospital mortality and lengths of stay were not statistically significantly different. Adjustment for Acute Physiology and Chronic Health Evaluation Version IVa score, ICU type, and ICU admission time via logistic regression yielded significantly lower ICU and hospital mortality odds ratios of 0.58 (95% CI, 0.45-0.74) and 0.66 (95% CI, 0.54-0.80), respectively. When adjusting for acuity by comparing observed-over-expected length of stay ratios through Acute Physiology and Chronic Health Evaluation IVa methodology, we found significantly lower ICU and hospital length of stay in the postintervention group. ICU mortality improvements were driven by nighttime ICU admissions (odds ratio 0.45 [95% CI, 0.33-0.61]) as compared to daytime ICU admissions (odds ratio 0.81 [95% CI, 0.55-1.20]), whereas hospital mortality improvements were seen in both subgroups but more prominently in nighttime ICU admissions (odds ratio 0.57 [95% CI, 0.44-0.74]) as compared to daytime ICU admissions (odds ratio 0.73 [95% CI, 0.55-0.97]), suggesting that telemedicine ICU intervention can effectively supplement low intensity bedside staffing hours (nighttime). CONCLUSIONS: In this pre-post observational study, telemedicine ICU intervention was associated with improvements in care standardization and decreases in ICU and hospital mortality and length of stay. The mortality benefits were mediated in part through telemedicine ICU supplementation of low intensity bedside staffing hours.

Use of ultrasound guidance in central venous catheter placement by emergency physicians in Saudi Arabia.

OBJECTIVES: To determine the ultrasound guidance for central venous catheter (USG-CVC) placement rate of emergency physicians (EPs) in Kingdom of Saudi Arabia. METHODS: A cross-sectional survey study regarding the respondents' demographic profiles, formal and informal training in USG-CVC placement, experiences, and attitudes towards the procedure was emailed to all EPs registered with the Saudi Commission for Health Specialties (SCFHS) between October and December 2018. RESULTS: In total, 234/350 SCFHS-registered EPs completed the survey; the response rate was 66.9%. Most respondents (70.5%) were board-certified in emergency medicine (EM). Ninety percent indicated that US device for CVC placement assistance was available. Most EPs (78.2%) had performed USG-CVC placement; the US usage rate correlated significantly with recent graduation from residency (p=0.048). In total, 83.3% received formal training during residency. Of the 234 respondents, 53.8% felt extremely comfortable with CVC placement with USG and 19.7% without USG (p less than 0.01). Nevertheless, most respondents desired further USG-CVC training. CONCLUSION: Despite existing evidence and a consensus on its superiority over the landmark technique, USG-CVC placement has not been adopted by a small proportion of EPs into clinical practice. Formal training, education, and institutional provision of permanent onsite US machines may address any barriers.