Alternative approaches to analyzing ventilator-free days, mortality and duration of ventilation in critical care research.

OBJECTIVE: To discuss the strengths and limitations of ventilator-free days and to provide a comprehensive discussion of the different analytic methods for analyzing and interpreting this outcome. METHODS: Using simulations, the power of different analytical methods was assessed, namely: quantile (median) regression, cumulative logistic regression, generalized pairwise comparison, conditional approach and truncated approach. Overall, 3,000 simulations of a two-arm trial with n = 300 per arm were computed using a two-sided alternative hypothesis and a type I error rate of α = 0.05. RESULTS: When considering power, median regression did not perform well in studies where the treatment effect was mainly driven by mortality. Median regression performed better in situations with a weak effect on mortality but a strong effect on duration, duration only, and moderate mortality and duration. Cumulative logistic regression was found to produce similar power to the Wilcoxon rank-sum test across all scenarios, being the best strategy for the scenarios of moderate mortality and duration, weak mortality and strong duration, and duration only. CONCLUSION: In this study, we describe the relative power of new methods for analyzing ventilator-free days in critical care research. Our data provide validation and guidance for the use of the cumulative logistic model, median regression, generalized pairwise comparisons, and the conditional and truncated approach in specific scenarios.

Perioperative dexmedetomidine compared to midazolam in children undergoing open-heart surgery: A pilot randomised controlled trial.

Objective: There is a need for evidence on the best sedative agents in children undergoing open heart surgery for congenital heart disease. This study aimed to evaluate the feasibility and safety of dexmedetomidine in this group compared with midazolam. Design: Double blinded, pilot randomized controlled trial. Setting: Cardiac operating theatre and paediatric intensive care unit in Brisbane, Australia. Participants: Infants (≤12 months of age) undergoing their first surgical repair of a congenital heart defect. Interventions: Dexmedetomidine (up to 1.0mcg/kg/hr) versus midazolam (up to 80mcg/kg/hr), commenced in the cardiac operating theatre prior to surgery. Main outcome measures: The primary outcome was the time spent in light sedation (Sedation Behavior Scale [SBS] -1 to +1); Co-primary feasibility outcome was recruitment, retention and protocol adherence. Secondary outcomes were use of supplemental sedatives, ventilator free days, delirium, vasoactive drug support, and adverse events. Neurodevelopment and health-related quality of life (HRQoL) were assessed at 12 months post-surgery. Results: Sixty-six participants were recruited. The number of SBS scores in the light sedation range were greater in the dexmedetomidine group at 24 hours, 48 hours, and overall study duration (0-14 days) versus the midazolam group (24hr: 76/170 [45%] vs 60/178 [34%], aOR 4.14 [95% CI 0.48, 35.92]; 48hr: 154/298 [52%] vs 122/314 [39%], aOR 6.95 [95% CI 0.77, 63.13]; 0-14 days: 597/831 [72%] vs 527/939 [56%], aOR 3.93 [95% CI 0.62, 25.03]). Feasibility was established with no withdrawals or loss to follow-up at 14 days and minimal protocol deviations. There were no differences between the groups relating to clinical, safety, neurodevelopment or HRQoL outcomes. Conclusions: The use of dexmedetomidine was associated with more time spent in light sedation when compared with midazolam. The feasibility of conducting a blinded RCT of midazolam and dexmedetomidine in children undergoing open heart surgery was also established. The findings justify further investigation in a larger trial. Clinical trial registration: ACTRN12615001304527.

Safety Goggles with Elastic Headband to Improve N95 Fit Following Failed Quantitative Fit Test.

Introduction: N95 respirators, together with eye protection, form vital elements of personal protective equipment (PPE) for healthcare workers (HCW) caring for patients with respiratory infections, such as COVID-19. Duckbill N95 respirators are widely used but have a high failure rate when Fit Tested. The commonest site for inward leaks is the region between the nose and maxilla. Safety goggles with an elastic headband may press the upper rim of the respirator against the face, thereby reducing inward leaks. We hypothesized that the use of safety goggles with an elastic headband will improve the overall fit-factor of a duckbill N95 respirator and increase the proportion of users who pass a quantitative Fit Test. Methods: About 60 volunteer HCWs, who had previously failed quantitative Fit Testing with a duckbill N95 respirator, participated in this before-and-after intervention study. A PortaCount® 8048 was used for quantitative Fit Testing. The test was first performed with a duckbill N95 respirator only. It was then repeated after participants donned a pair of safety goggles (3M Fahrenheit, ID 70071531621). Results: Before the intervention, i.e., with the respirator only, 8 (13.3%) participants passed their Fit Test. This increased to 49 (81.7%) after the application of safety goggles (OR 42, 95% CI 7.14-1697.9, p < 0.0001). The adjusted mean overall fit factor, using Tobit regression analysis, increased from 40.3 to 193.0 (t = 12.32, p < 0.001). Conclusion: The use of safety goggles with an elastic headband significantly increases the proportion of users who pass a quantitative Fit Test and improves the fit-factor of a duckbill N95 respirator. How to cite this article: Kamal M, Bhatti M, Stewart WC, Johns M, Collins D, Shehabi Y, et al. Safety Goggles with Elastic Headband to Improve N95 Fit Following Failed Quantitative Fit Test. Indian J Crit Care Med 2023;27(6):386-391.

Non-inferiority trial of a shorter (7 days) compared with a longer (14 days) duration of antimicrobial therapy for the treatment of bacteraemic urinary sepsis, measured by microbiological success after the completion of therapy: a substudy protocol for the Bacteraemia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) multicentre randomised controlled trial.

INTRODUCTION: The BALANCE study is a randomised clinical trial (3626 participants) designed to assess the non-inferiority of 7 days (short-course) antibiotic therapy compared with 14 days of therapy for bacteraemia using the pragmatic endpoint of 90-day survival. Based on pilot study data, approximately 30% of enrolees will have a urinary tract infection (UTI) as the source of bacteraemia. METHODS AND ANALYSIS: We aim to assess the non-inferiority of short-course antibiotic therapy for patients with bacteraemia UTIs.Participating sites in four countries will be invited to join this substudy. All participants of this substudy will be enrolled in the main BALANCE study. The intervention will be assigned and treatment administered as specified in the main protocol.We will include participants in this substudy if the probable source of their infection is a UTI, as judged by the site principal investigator, and they have a urine microscopy and culture indicative of a UTI. Participants will be excluded if they have an ileal loop, vesicoureteric reflux or suspected or confirmed prostatitis.The primary outcome is the absence of a positive culture on a test-of-cure urine sample collected 6-12 days after cessation of antimicrobials, with a non-inferiority margin of 15%. Secondary outcomes include the clinical resolution of infection symptoms at test-of-cure. ETHICS AND DISSEMINATION: The study has been approved in conjunction with the main BALANCE study through the relevant ethics review process at each participating site. We will disseminate the results through the Australasian Society for Infectious Diseases, Canadian Critical Care Trials Group, the Association for Medical Microbiology and Infectious Diseases Canada Clinical Research Network (AMMI Canada CRN) and other collaborators. UNIVERSAL TRIAL NUMBER: U1111-1256-0874. MAIN BALANCE TRIAL REGISTRATION: NCT03005145. TRIAL REGISTRATION NUMBER: Australian Clinical Trial Register: ACTRN12620001108909.

Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial.

OBJECTIVES: To identify the best population, design of the intervention, and to assess between-group biochemical separation, in preparation for a future phase III trial. DESIGN: Investigator-initiated, parallel-group, pilot randomized double-blind trial. SETTING: Eight ICUs in Australia, New Zealand, and Japan, with participants recruited from April 2021 to August 2022. PATIENTS: Thirty patients greater than or equal to 18 years, within 48 hours of admission to the ICU, receiving a vasopressor, and with metabolic acidosis (pH < 7.30, base excess [BE] < -4 mEq/L, and Pa co2 < 45 mm Hg). INTERVENTIONS: Sodium bicarbonate or placebo (5% dextrose). MEASUREMENTS AND MAIN RESULT: The primary feasibility aim was to assess eligibility, recruitment rate, protocol compliance, and acid-base group separation. The primary clinical outcome was the number of hours alive and free of vasopressors on day 7. The recruitment rate and the enrollment-to-screening ratio were 1.9 patients per month and 0.13 patients, respectively. Time until BE correction (median difference, -45.86 [95% CI, -63.11 to -28.61] hr; p < 0.001) and pH correction (median difference, -10.69 [95% CI, -19.16 to -2.22] hr; p = 0.020) were shorter in the sodium bicarbonate group, and mean bicarbonate levels in the first 24 hours were higher (median difference, 6.50 [95% CI, 4.18 to 8.82] mmol/L; p < 0.001). Seven days after randomization, patients in the sodium bicarbonate and placebo group had a median of 132.2 (85.6-139.1) and 97.1 (69.3-132.4) hours alive and free of vasopressor, respectively (median difference, 35.07 [95% CI, -9.14 to 79.28]; p = 0.131). Recurrence of metabolic acidosis in the first 7 days of follow-up was lower in the sodium bicarbonate group (3 [20.0%] vs. 15 [100.0%]; p < 0.001). No adverse events were reported. CONCLUSIONS: The findings confirm the feasibility of a larger phase III sodium bicarbonate trial; eligibility criteria may require modification to facilitate recruitment.

Current practice, education and recommendations for training of central line insertion for trainees and fellows in adult intensive care units across Australia and New Zealand.

BACKGROUND: Central venous access device (CVAD) is a common procedure in ICU which, although generally safe, can lead to acute and delayed complications. Training and accreditation process for its insertion vary worldwide. AIMS: The objective of this study was to explore variability in existing training and accreditation processes for central venous access device (CVAD) insertion among different intensive care units (ICU), current practices of CVAD insertion among fellows of the College of Intensive Care Medicine (CICM) working in Australia and New Zealand (ANZ) and their recommendations for improvement. METHODS: A prospective cross-sectional web-based survey was sent through email and CICM e-newsletter to intensivists and directors of ICU across ANZ. All responses were tabulated, post-hoc exploratory analysis using multivariable ordinal logistic regression was used and free texts were analysed thematically and summarised. RESULTS: A total of 115 responses was received from various public and private ICU from all states of ANZ; 32% of the participants did not have any accreditation process for CVAD insertion skill in their ICU, whereas 91% of respondents revealed there were no processes to assess deskilling. Most intensivists recommended supervision, simulation, various education tools and ultrasound training to improve training and assessment. Thirty-five percent of the participants inserted 0-5 CVAD and more than half of the intensivists had inserted <10 CVAD in a 1-year period. Two-thirds of the respondents recommended inserting between 6 and 20 CVAD each year to maintain competence. CONCLUSION: The study identified wide variability in current practice, training methods and accreditation process for CVAD insertion among intensivists and ICU trainees in ANZ. Policy makers should consider revising the current clinical practice and training policies to new policies for accreditation and ongoing assessment for CVAD insertions across ANZ ICU.

Correlation of patient-reported outcome measures to performance-based function in critical care survivors: PREDICTABLE.

BACKGROUND: Establishing sequela following critical illness is a public health priority; however, recruitment and retention of this cohort make assessing functional outcomes difficult. Completing patient-reported outcome measures (PROMs) via telephone may improve participant and researcher involvement; however, there is little evidence regarding the correlation of PROMs to performance-based outcome measures in critical care survivors. OBJECTIVES: The objective of this study was to assess the relationship between self-reported and performance-based measures of function in survivors of critical illness. METHODS: This was a nested cohort study of patients enrolled within a previously published study determining predictors of disability-free survival. Spearman's correlation (rs) was calculated between four performance-based outcomes (the Functional Independence Measure [FIM], 6-min walk distance [6MWD], Functional Reach Test [FRT], and grip strength) that were collected during a home visit 6 months following their intensive care unit admission, with two commonly used PROMs (World Health Organization Disability Assessment Scale 2.0 12 Level [WHODAS 2.0] and EuroQol-5 Dimension-5 Level [EQ-5D-5L]) obtained via phone interview (via the PREDICT study) at the same time point. RESULTS: There were 38 PROMs obtained from 40 recruited patients (mean age = 59.8 ± 16 yrs, M:F = 24:16). All 40 completed the FIM and grip strength, 37 the 6MWD, and 39 the FRT. A strong correlation was found between the primary outcome of the WHODAS 2.0 with all performance-based outcomes apart from grip strength where a moderate correlation was identified. Although strong correlations were also established between the EQ-5D-5L utility score and the FIM, 6MWD, and FRT, it only correlated weakly with grip strength. The EQ-5D overall global health rating only had very weak to moderate correlations with the performance-based outcomes. CONCLUSION: The WHODAS 2.0 correlated stronger across multiple performance-based outcome measures of functional recovery and is recommended for use in survivors of critical illness.

Dexmedetomidine and Propofol Sedation in Critically Ill Patients and Dose-associated 90-Day Mortality: A Secondary Cohort Analysis of a Randomized Controlled Trial (SPICE III).

Rationale: The SPICE III (Sedation Practice in Intensive Care Evaluation) trial reported significant heterogeneity in mortality with dexmedetomidine treatment. Supplemental propofol was commonly used to achieve desirable sedation. Objectives: To quantify the association of different infusion rates of dexmedetomidine and propofol, given in combination, with mortality and to determine if this is modified by age. Methods: We included 1,177 patients randomized in SPICE III to receive dexmedetomidine and given supplemental propofol, stratified by age (>65 or ⩽65 yr). We used double stratification analysis to produce quartiles of steady infusion rates of dexmedetomidine while escalating propofol dose and vice versa. We used Cox proportional hazard and multivariable regression adjusted for relevant clinical variable to evaluate the association of sedative dose with 90-day mortality. Measurements and Main Results: Younger patients (598 of 1,177 [50.8%]) received significantly higher doses of both sedatives compared with older patients to achieve comparable sedation depth. On double stratification analysis, escalating infusion rates of propofol to 1.27 mg/kg/h at a steady dexmedetomidine infusion rate (0.54 µg/kg/h) was associated with reduced adjusted mortality in younger but not older patients. This was consistent with multivariable regression modeling (hazard ratio, 0.59; 95% confidence interval, 0.43-0.78; P < 0.0001) adjusted for baseline risk and interaction with dexmedetomidine dose. In contrast, among younger patients, using multivariable regression, escalating dexmedetomidine infusion rate was associated with increased adjusted mortality (hazard ratio, 1.30; 95% confidence interval, 1.03-1.65; P = 0.029). Conclusions: In patients ⩽65 years of age sedated with dexmedetomidine and propofol combination, preferentially increasing the dose of propofol was associated with decreased adjusted 90-day mortality. Conversely, increasing dexmedetomidine may be associated with increased mortality. Clinical trial registered with www.clinicaltrials.gov (NCT01728558).

Stress response during early sedation with dexmedetomidine compared with usual-care in ventilated critically ill patients.

BACKGROUND: Sedative agents may variably impact the stress response. Dexmedetomidine is a sympatholytic alpha2-adrenergic agonist mainly used as a second-line sedative agent in mechanically ventilated patients. We hypothesised that early sedation with dexmedetomidine as the primary agent would result in a reduced stress response compared to usual sedatives in critically ill ventilated adults. METHODS: This was a prospective sub-study nested within a multi-centre randomised controlled trial of early sedation with dexmedetomidine versus usual care. The primary outcome was the mean group differences in plasma levels of stress response biomarkers measured over 5 days following randomisation. Other hormonal, biological and physiological parameters were collected. Subgroup analyses were planned for patients with proven or suspected sepsis. RESULTS: One hundred and three patients were included in the final analysis. Baseline illness severity (APACHE II score), the proportion of patients receiving propofol and the median dose of propofol received were comparable between groups. More of the usual-care patients received midazolam (57.7% vs 33.3%; p = 0.01) and at higher dose (median (95% interquartile range) 0.46 [0.20-0.93] vs 0.14 [0.08-0.38] mg/kg/day; p < 0.01). The geometric mean (95% CI) plasma level of the stress hormones, adrenaline (0.32 [0.26-0.4] vs 0.38 [0.31-0.48]), noradrenaline (4.27 [3.12-5.85] vs 6.2 [4.6-8.5]), adrenocorticotropic hormone (17.1 [15.1-19.5] vs 18.1 [15.9-20.5]) and cortisol (515 [409-648] vs 618 [491-776)] did not differ between dexmedetomidine and usual-care groups, respectively. There were no significant differences in any other assayed biomarkers or physiological parameters Sensitivity analyses showed no effect of age or sepsis. CONCLUSIONS: Early sedation with dexmedetomidine as the primary sedative agent in mechanically ventilated critically ill adults resulted in comparable changes in physiological and blood-borne parameters associated with the stress-response as with usual-care sedation.

The future of intensive care: delirium should no longer be an issue.

In the ideal intensive care unit (ICU) of the future, all patients are free from delirium, a syndrome of brain dysfunction frequently observed in critical illness and associated with worse ICU-related outcomes and long-term cognitive impairment. Although screening for delirium requires limited time and effort, this devastating disorder remains underestimated during routine ICU care. The COVID-19 pandemic brought a catastrophic reduction in delirium monitoring, prevention, and patient care due to organizational issues, lack of personnel, increased use of benzodiazepines and restricted family visitation. These limitations led to increases in delirium incidence, a situation that should never be repeated. Good sedation practices should be complemented by novel ICU design and connectivity, which will facilitate non-pharmacological sedation, anxiolysis and comfort that can be supplemented by balanced pharmacological interventions when necessary. Improvements in the ICU sound, light control, floor planning, and room arrangement can facilitate a healing environment that minimizes stressors and aids delirium prevention and management. The fundamental prerequisite to realize the delirium-free ICU, is an awake non-sedated, pain-free comfortable patient whose management follows the A to F (A-F) bundle. Moreover, the bundle should be expanded with three additional letters, incorporating humanitarian care: gaining (G) insight into patient needs, delivering holistic care with a 'home-like' (H) environment, and redefining ICU architectural design (I). Above all, the delirium-free world relies upon people, with personal challenges for critical care teams to optimize design, environmental factors, management, time spent with the patient and family and to humanize ICU care.

Dexmedetomidine vs other sedatives in critically ill mechanically ventilated adults: a systematic review and meta-analysis of randomized trials.

Conventional gabaminergic sedatives such as benzodiazepines and propofol are commonly used in mechanically ventilated patients in the intensive care unit (ICU). Dexmedetomidine is an alternative sedative that may achieve lighter sedation, reduce delirium, and provide analgesia. Our objective was to perform a comprehensive systematic review summarizing the large body of evidence, determining if dexmedetomidine reduces delirium compared to conventional sedatives. We searched MEDLINE, EMBASE, CENTRAL, ClinicalTrials.gov and the WHO ICTRP from inception to October 2021. Independent pairs of reviewers identified randomized clinical trials comparing dexmedetomidine to other sedatives for mechanically ventilated adults in the ICU. We conducted meta-analyses using random-effects models. The results were reported as relative risks (RRs) for binary outcomes and mean differences (MDs) for continuous outcomes, with corresponding 95% confidence intervals (CIs). In total, 77 randomized trials (n = 11,997) were included. Compared to other sedatives, dexmedetomidine reduced the risk of delirium (RR 0.67, 95% CI 0.55 to 0.81; moderate certainty), the duration of mechanical ventilation (MD - 1.8 h, 95% CI - 2.89 to - 0.71; low certainty), and ICU length of stay (MD - 0.32 days, 95% CI - 0.42 to - 0.22; low certainty). Dexmedetomidine use increased the risk of bradycardia (RR 2.39, 95% CI 1.82 to 3.13; moderate certainty) and hypotension (RR 1.32, 95% CI 1.07 to 1.63; low certainty). In mechanically ventilated adults, the use of dexmedetomidine compared to other sedatives, resulted in a lower risk of delirium, and a modest reduction in duration of mechanical ventilation and ICU stay, but increased the risks of bradycardia and hypotension.

Use of dexmedetomidine for sedation in mechanically ventilated adult ICU patients: a rapid practice guideline.

PURPOSE: The aim of this Intensive Care Medicine Rapid Practice Guideline (ICM­RPG) was to formulate evidence­based guidance for the use of dexmedetomidine for sedation in invasively mechanically ventilated adults in the intensive care unit (ICU). METHODS: We adhered to the methodology for trustworthy clinical practice guidelines, including use of the Grading of Recommendations Assessment, Development, and Evaluation approach to assess the certainty of evidence, and the Evidence-to-Decision framework to generate recommendations. The guideline panel comprised 28 international panelists, including content experts, ICU clinicians, methodologists, and patient representatives. Through teleconferences and web­based discussions, the panel provided input on the balance and magnitude of the desirable and undesirable effects, the certainty of evidence, patients' values and preferences, costs and resources, feasibility, acceptability, and research priorities. RESULTS: The ICM­RPG panel issued one weak recommendation (suggestion) based on overall moderate certainty of evidence: "In invasively mechanically ventilated adult ICU patients, we suggest using dexmedetomidine over other sedative agents, if the desirable effects including a reduction in delirium are valued over the undesirable effects including an increase in hypotension and bradycardia". CONCLUSION: This ICM-RPG provides updated evidence-based guidance on the use of dexmedetomidine for sedation in mechanically ventilated adults, and outlines uncertainties and research priorities.

Practices in sedation, analgesia, mobilization, delirium, and sleep deprivation in adult intensive care units (SAMDS-ICU): an international survey before and during the COVID-19 pandemic.

BACKGROUND: Since the publication of the 2018 Clinical Guidelines about sedation, analgesia, delirium, mobilization, and sleep deprivation in critically ill patients, no evaluation and adequacy assessment of these recommendations were studied in an international context. This survey aimed to investigate these current practices and if the COVID-19 pandemic has changed them. METHODS: This study was an open multinational electronic survey directed to physicians working in adult intensive care units (ICUs), which was performed in two steps: before and during the COVID-19 pandemic. RESULTS: We analyzed 1768 questionnaires and 1539 (87%) were complete. Before the COVID-19 pandemic, we received 1476 questionnaires and 292 were submitted later. The following practices were observed before the pandemic: the Visual Analog Scale (VAS) (61.5%), the Behavioral Pain Scale (BPS) (48.2%), the Richmond Agitation Sedation Scale (RASS) (76.6%), and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) (66.6%) were the most frequently tools used to assess pain, sedation level, and delirium, respectively; midazolam and fentanyl were the most frequently used drugs for inducing sedation and analgesia (84.8% and 78.3%, respectively), whereas haloperidol (68.8%) and atypical antipsychotics (69.4%) were the most prescribed drugs for delirium treatment; some physicians regularly prescribed drugs to induce sleep (19.1%) or ordered mechanical restraints as part of their routine (6.2%) for patients on mechanical ventilation; non-pharmacological strategies were frequently applied for pain, delirium, and sleep deprivation management. During the COVID-19 pandemic, the intensive care specialty was independently associated with best practices. Moreover, the mechanical ventilation rate was higher, patients received sedation more often (94% versus 86.1%, p < 0.001) and sedation goals were discussed more frequently in daily rounds. Morphine was the main drug used for analgesia (77.2%), and some sedative drugs, such as midazolam, propofol, ketamine and quetiapine, were used more frequently. CONCLUSIONS: Most sedation, analgesia and delirium practices were comparable before and during the COVID-19 pandemic. During the pandemic, the intensive care specialty was a variable that was independently associated with the best practices. Although many findings are in accordance with evidence-based recommendations, some practices still need improvement.

Prediction of N95 Respirator Fit from Fogging of Eyeglasses: A Pilot Study.

AIM AND OBJECTIVE: Fogging of eyeglasses while wearing N95 respirators is common. It is commonly held that the N95 respirator has a poor fit if there is fogging of eyeglasses. We conducted this prospective, pilot study to determine if fogging of eyeglasses predicts poor fit of N95 respirator. MATERIALS AND METHODS: Seventy volunteer healthcare workers from a tertiary intensive care unit in Sydney, Australia participated. The participants donned one of the following N95 respirators: three-panel flat-fold respirator (3M 1870), cup-shaped respirator (3M 1860), or a duckbill respirator. After a satisfactory "user seal check" as recommended by the manufacturer, the participants donned eyeglasses and checked for fogging. A quantitative fit test (QnFT) of the respirator was then performed (using PortaCount Respirator Fit Tester 8048, TSI Inc., Minnesota, USA). A fit factor of <100 on quantitative fit testing indicates poor fit. The sensitivity and specificity for fogging of eyeglasses (index test) to predict the poor fit of N95 respirator was determined, compared to QnFT (gold standard test). RESULTS: Fogging of eyeglasses as a predictor of poor respirator fit (i.e., fit factor <100 on QnFT) had sensitivity of 71% (95% CI, 54-85%) and specificity 46% (95% CI, 29-63%). The odds ratio of fogging as a predictor for poor fit was 2.10 (95% CI, 0.78-5.67), with a two-tailed p-value of 0.22 (not significant). The receiver operating characteristic curve for fogging of eyeglasses as a diagnostic test had the area under the curve of 0.59. CONCLUSION: Fogging of eyeglasses is neither a sensitive nor a specific predictor for poor fit of N95 respirators. HOW TO CITE THIS ARTICLE: Kyaw S, Johns M, Lim R, Stewart WC, Rojas N, Thambiraj SR, et al. Prediction of N95 Respirator Fit from Fogging of Eyeglasses: A Pilot Study. Indian J Crit Care Med 2021;25(9):976-980.

Fit Factor Change on Quantitative Fit Testing of Duckbill N95 Respirators with the Use of Safety Goggles.

N95 respirators and safety goggles are important components of personal protective equipment to reduce the spread of airborne infections, such as COVID-19, among healthcare workers. Poor N95 respirator seal may reduce its protective effect, thereby increasing transmission. Quantitative fit testing is an established way of assessing the N95 respirator fit, which provides a quantitative measure for seal, called the fit factor. Duckbill N95 respirators frequently fail the fit test. We hypothesized that using safety goggles with a wraparound elastic headband will increase their fit-factor by reinforcing the seal between the face and the upper margin of the respirator. We studied the effect of safety goggles with a wraparound elastic headband (3M™ Chemical Splash Resistant Goggles, ID 70006982741) on the fit factor of two types of Duckbill N95 respirators (Halyard FLUIDSHIELD*3, Model 99SA070M, and ProShield® N95 Model TN01-11) in 63 healthy volunteers in a nonrandomized, before-and-after intervention study design. The mean fit factor increased from 69.4 to 169.1 increased from 17/63 (27%) to 46/63 (73%) after the intervention (p <0.0001, OR 3 [95% CI = 4.9-1223]). This is the first study to explore the impact of safety goggles on N95 respirator fit. We conclude that the use of safety goggles with a wraparound elastic headband increases the fit factor of the tested Duckbill N95 respirators. HOW TO CITE THIS ARTICLE: Johns M, Kyaw S, Lim R, Stewart WC, Thambiraj SR, Shehabi Y, et al. Fit Factor Change on Quantitative Fit Testing of Duckbill N95 Respirators with the Use of Safety Goggles. Indian J Crit Care Med 2021;25(9):981-986.

Postoperative 20% albumin vs standard care and acute kidney injury after high-risk cardiac surgery (ALBICS): study protocol for a randomised trial.

BACKGROUND: Acute kidney injury (AKI) is a common complication of cardiac surgery. Factors such as cardiopulmonary bypass, aortic cross-clamping and surgical stress may precipitate renal hypoperfusion and ischaemia, inflammation and oxidative stress are associated with development of AKI. Albumin's pharmacological properties and widespread availability have the potential to mitigate these factors. However, the effect of albumin on cardiac surgery-associated AKI is unknown. OBJECTIVE: To evaluate the impact of postoperative 20% albumin infusion on kidney function after high-risk cardiac surgery. METHODS: We designed an open-label, multicentre, randomised controlled trial-the ALBICS study (ALBumin Infusion and acute kidney injury following Cardiac Surgery). A total of 590 patients undergoing high-risk cardiac surgery (combined procedure or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2) will be enrolled into the study and randomly allocated to receive a postoperative 20% albumin infusion or standard care in a 1:1 ratio, stratified by centre and baseline renal function. The study fluid will be administered upon arrival in intensive care for 15 h. Patients will be followed up until 28 days after surgery or until discharge from the hospital. The primary outcome is the proportion of patients who develop AKI in both groups. Secondary outcomes to be measured are proportions of AKI stage II and III, 28-day mortality, mechanical ventilation time and length of stay in intensive care and hospital. CONCLUSION: This trial aims to determine if a postoperative infusion of concentrated albumin reduces the risk of AKI following high-risk cardiac surgery. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001355167. Registered on 03 October 2019-retrospectively registered. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378383 .