Diagnostic accuracy and feasibility of portable sleep monitoring in patients with obstructive sleep apnea: Re-exploring the utility in the current COVID-19 pandemic.

Portable sleep monitoring (PSM) is a promising alternative diagnostic tool for Obstructive Sleep Apnea (OSA) especially in high burden resource limited settings. We aimed to determine the diagnostic accuracy and feasibility of PSM device-based studies in patients presenting for evaluation of OSA at a tertiary care hospital in North-India. PSM studies (using a Type-III PSM device) were compared for technical reliability and diagnostic accuracy with the standard laboratory-based Type-I polysomnography (PSG). Patients were also interviewed about their experience on undergoing an unsupervised PSM studies. Fifty patients (68% males) were enrolled in the study, of which only 30% patients expressed their concerns about undergoing unsupervised PSM studies which included safety issues, ease of use, diagnostic accuracy, etc. Technical acceptability criteria were easily met by the PSM studies with signal loss in 12% studies (complete data loss and inaccessible data in 6% studies), warranting repetition sleep studies in four patients. The overall sensitivity of PSM device (AHI ≥5) was 93.5% (area under curve; AUC: 0.87). The diagnostic accuracy was 68.5%, 80%, and 91.4% for mild, moderate, and severe cases of OSA, respectively. An overall strong correlation was observed between PSM-AHI (apnoea-hypopnoea index) and PSG (r>0.85, p≤0.001), especially in severe OSA. The observed sensitivity was >90% for AHI>20 (clinically significant OSA), with high specificity of 91% for severe OSA (AUC: 0.94, 0.97 for AHI>20, AHI>30 respectively). The overall Bland-Altman concordance analysis also demonstrated only a small dispersion for PSM studies with a Cronbach's coefficient of 0.95. Therefore, there is good diagnostic accuracy as well as feasibility of home-based portable sleep studies in Indian patients. It can be promoted for widespread use in high burden countries like India for diagnosing and managing appropriately selected stable patients with high clinical probability of OSA, especially during the ongoing crises of COVID-19 pandemic.

Development of RNA-Based Assay for Rapid Detection of SARS-CoV-2 in Clinical Samples.

INTRODUCTION: The ongoing spread of pandemic coronavirus disease-19 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is of growing concern. Rapid diagnosis and management of SARS-CoV-2 are crucial for controlling the outbreak in the community. Here, we report the development of a first rapid-colorimetric assay capable of detecting SARS-CoV-2 in the human nasopharyngeal RNA sample in less than 30 min. METHOD: We utilized a nanomaterial-based optical sensing platform to detect RNA-dependent RNA polymerase gene of SARS-CoV-2, where the formation of oligo probe-target hybrid led to salt-induced aggregation and change in gold-colloid color from pink to blue visibility range. Accordingly, we found a change in colloid color from pink to blue in assay containing nasopharyngeal RNA sample from the subject with clinically diagnosed COVID-19. The colloid retained pink color when the test includes samples from COVID-19 negative subjects or human papillomavirus-infected women. RESULTS: The results were validated using nasopharyngeal RNA samples from positive COVID-19 subjects (n = 136). Using real-time polymerase chain reaction as gold standard, the assay was found to have 85.29% sensitivity and 94.12% specificity. The optimized method has detection limit as little as 0.5 ng of SARS-CoV-2 RNA. CONCLUSION: We found that the developed assay rapidly detects SARS-CoV-2 RNA in clinical samples in a cost-effective manner and would be useful in pandemic management by facilitating mass screening.

Depression and Anxiety among COVID-19 Indian Intensive Care Unit Survivors: A Prospective Observational Study.

Background: Long-lasting physical, cognitive, and mental health sequelae including depression and anxiety are common in intensive care unit (ICU) survivors. Aim: This study was aimed to assess the immediate and medium-term mental health sequelae-depression and anxiety among coronavirus disease-2019 (COVID-19) ICU survivors. Materials and methods: The COVID-19 ICU survivors of a tertiary level ICU were recruited into this study from 1 July 2020 to 31 October 2020. Willing participants were circulated with an electronic questionnaire. It consisted of demographics and questionnaires related to COVID-19 disease, comorbidities, and a patient health questionnaire (PHQ-9) scale for depression, and generalized anxiety disorder (GAD-7) scale for anxiety. Responses were collected at the time of discharge. Follow-up was done at 2 weeks and 6 months. Results: Among the 133 COVID-19 ICU survivors contacted, 91 survivors submitted the baseline data at the time of discharge. Fourteen and another 11 survivors were lost to follow-up at 2 weeks and at 6 months. The median age was 52.75 and 68.1% (n = 62/91) were male. The median PHQ-9 and GAD-7 scores showed a statistically significant decrease at 2 weeks and a non-significant decrease at 6 months compared to baseline scores. The GAD-7 score was the same or worse between baselines to 2 weeks, but it reduced between baseline to 6 months for all variables and their subgroups. Conclusion: This study revealed a high prevalence of anxiety and depression in the immediate post-discharge period. These findings suggest the need for better mental rehabilitation strategies to deal with the well-being of critically ill survivors in future pandemics. How to cite this article: Gunjiganvi M, Rai S, Awale RB, Mishra P, Gurjar M, Gupta D, et al. Depression and Anxiety among COVID-19 Indian Intensive Care Unit Survivors: A Prospective Observational Study. Indian J Crit Care Med 2022;26(12):1267-1274.

Association of hyperglycaemia at-admission & diabetes mellitus with 28 day mortality in patients admitted with moderate-severe SARS-CoV-2 infection: A retrospective study.

Background & objectives: The association between hyperglycaemia at admission, diabetes mellitus (DM) status and mortality in hospitalized SARS-CoV-2 infected patients is not clear. The purpose of this study was to determine the relationship between DM, at-admission hyperglycaemia and 28 day mortality in patients admitted with moderate-severe SARS-CoV-2 infection requiring intensive care. Methods: All consecutive moderate-to-severe patients with SARS-CoV-2 infection admitted to the intensive care units (ICUs) over six months were enrolled in this single-centre, retrospective study. The predicators for 28 day mortality were analysed from the independent variables including DM status and hyperglycaemia at-admission. Results: Four hundred and fifty two patients with SARS-CoV-2 were admitted to the ICU, with a mean age of 58.5±13.4 yr, 78.5 per cent being male, HbA1c of 7.2 per cent (6.3-8.8) and 63.7 per cent having DM. Overall, 28 day mortality was 48.9 per cent. In univariate analysis, mortality in diabetes patients was comparable with non-diabetes (47.9 vs. 50.6%, P=0.58), while it was significantly higher in hyperglycaemic group (60.4 vs. 35.8%, P<0.001). In multivariate Cox regression analysis, after adjusting for age, sex and comorbidities, hyperglycaemia at-admission was an independent risk factor of mortality [hazard ratio (HR) 1.45, 95% confidence interval (CI) (1.06-1.99), P<0.05]. Interpretation & conclusions: This study showed that the presence of hyperglycaemia at-admission in critically ill SARS-CoV-2 patients was an independent predictor of 28 day mortality. However, the findings may be susceptible to unmeasured confounding, and more research from prospective studies is required.

Pattern of Conventional Coagulation and Thromboelastographic Parameters in Patients with COVID-19 Diseases and Association of COVID-Associated Coagulopathy with Mortality in Intensive Care Unit

Background: Knowledge of underlying pathophysiology of coagulopathy is evolving and the pattern of coagulation parameters in coronavirus disease 2019 (COVID-19)–associated diseases is still not very clear. Aims: In the present study, we aimed to find out the pattern and distribution of conventional coagulation parameters and thromboelastographic (TEG) parameters in COVID-19–associated coagulopathy (CAC) in survivors and nonsurvivors at 28 days. Setting and Design: The present prospective observational study was conducted at a tertiary care COVID-19 intensive care unit (ICU) facility from March 21, 2020, to July 15, 2021. Materials and Methods: Admission clinical and laboratory data (conventional coagulation, inflammatory and TEG parameters, and disease severity parameters) of 64 COVID-19 patients admitted to the ICU were collected. Patients were divided into two groups, i.e., survivors and nonsurvivors. Statistical Analysis: Data were compared between two groups, i.e., survivors versus no survivors on 28 days using Student's t-test/Mann–Whitney U-test or Chi-square test/Fisher's exact test. Results: Admission mean plasma fibrinogen levels (474.82 ± 167.41 mg.dL−1) and D-dimer were elevated (1.78 [0.66, 3.62] mg.mL−1) in the COVID-19 ICU patients. Overall, COVID-19 patients had mean lower normal platelet count (150 ± 50 × 103 cells.mm−3), with marginally elevated prothrombin time (16.25 ± 3.76 s) and activated partial thromboplastin time (38.22 ± 16.72 s). A 65.6% (42/64) TEG profile analysis showed a normal coagulation profile, and the rest 21.9% (14/64) and 12.5% (8/64) had hypercoagulable and hypocoagulable states, respectively. Plasma D-dimer level was markedly elevated in nonsurvivors compared to survivors (P < 0.05), while no other conventional coagulation parameters and TEG profile demonstrated statistically significant between the two groups. Conclusion: Markedly elevated plasma D-dimer level was observed in nonsurvivors of COVID-19 ICU patients. A large portion of COVID-19 ICU patients had a normal TEG profile. Conventional coagulation parameters and TEG profile were similar between survivors and nonsurvivors.

New insights into development and mortality of COVID-19-associated pulmonary aspergillosis in a homogenous cohort of 1161 intensive care patients.

BACKGROUND: COVID-19-associated pulmonary aspergillosis (CAPA) has been widely reported but homogenous large cohort studies are needed to gain real-world insights about the disease. METHODS: We collected clinical and laboratory data of 1161 patients hospitalised at our Institute from March 2020 to August 2021, defined their CAPA pathology, and analysed the data of CAPA/non-CAPA and deceased/survived CAPA patients using univariable and multivariable models. RESULTS: The overall prevalence and mortality of CAPA in our homogenous cohort of 1161 patients were 6.4% and 47.3%, respectively. The mortality of CAPA was higher than that of non-CAPA patients (hazard ratio: 1.8 [95% confidence interval: 1.1-2.8]). Diabetes (odds ratio [OR] 1.92 [1.15-3.21]); persistent fever (2.54 [1.17-5.53]); hemoptysis (7.91 [4.45-14.06]); and lung lesions of cavitation (8.78 [2.27-34.03]), consolidation (9.06 [2.03-40.39]), and nodules (8.26 [2.39-28.58]) were associated with development of CAPA by multivariable analysis. Acute respiratory distress syndrome (ARDS) (2.68 [1.09-6.55]), a high computed tomography score index (OR 1.18 [1.08-1.29]; p < .001), and pulse glucocorticoid treatment (HR 4.0 [1.3-9.2]) were associated with mortality of the disease. Whereas neutrophilic leukocytosis (development: 1.09 [1.03-1.15] and mortality: 1.17 [1.08-1.28]) and lymphopenia (development: 0.68 [0.51-0.91] and mortality: 0.40 [0.20-0.83]) were associated with the development as well as mortality of CAPA. CONCLUSION: We observed a low but likely underestimated prevalence of CAPA in our study. CAPA is a disease with high mortality and diabetes is a significant factor for its development while ARDS and pulse glucocorticoid treatment are significant factors for its mortality. Cellular immune dysregulation may have a central role in CAPA from its development to mortality.

The Spectrum of Invasive Fungal Sinusitis in COVID-19 Patients: Experience from a Tertiary Care Referral Center in Northern India.

This study aimed to determine the patient demographics, risk factors, which include comorbidities, medications used to treat COVID-19, and presenting symptoms and signs, and the management outcome of COVID-19-associated invasive fungal sinusitis. A retrospective, propensity score-matched, comparative study was conducted at a tertiary care center, involving 124 patients with invasive fungal sinusitis admitted between April 2021 and September 2021, suffering from or having a history of COVID-19 infection. Among the 124 patients, 87 were male, and 37 were female. A total of 72.6% of patients received steroids, while 73.4% received antibiotics, and 55.6% received oxygen during COVID-19 management. The most common comorbidities were diabetes mellitus (83.9%) and hypertension (30.6%). A total of 92.2% had mucor, 16.9% had aspergillus, 12.9% had both, and one patient had hyalohyphomycosis on fungal smear and culture. The comparative study showed the significant role of serum ferritin, glycemic control, steroid use, and duration in COVID-19-associated invasive fungal disease (p < 0.001). Headache and facial pain (68, 54.8%) were the most common symptoms. The most involved sinonasal site was the maxillary sinus (90, 72.6%). The overall survival rate at the three-month follow-up was 79.9%. COVID-19-related aggressive inflammatory response, uncontrolled glycemic level, and rampant use of steroids are the most important predisposing factors in developing COVID-19-associated invasive fungal sinusitis.

Survival analysis: A primer for the clinician scientists.

Survival analysis is a collection of statistical procedures employed on time-to-event data. The outcome variable of interest is time until an event occurs. Conventionally, it dealt with death as the event, but it can handle any event occurring in an individual like disease, relapse from remission, and recovery. Survival data describe the length of time from a time of origin to an endpoint of interest. By time, we mean years, months, weeks, or days from the beginning of being enrolled in the study. The major limitation of time-to-event data is the possibility of an event not occurring in all the subjects during a specific study period. In addition, some of the study subjects may leave the study prematurely. Such situations lead to what is called censored observations as complete information is not available for these subjects. Life table and Kaplan-Meier techniques are employed to obtain the descriptive measures of survival times. The main objectives of survival analysis include analysis of patterns of time-to-event data, evaluating reasons why data may be censored, comparing the survival curves, and assessing the relationship of explanatory variables to survival time. Survival analysis also offers different regression models that accommodate any number of covariates (categorical or continuous) and produces adjusted hazard ratios for individual factor.

Comparative evaluation of intubation performances using two different barrier devices used in the COVID-19 era: A manikin based pilot study.

BACKGROUND AND AIMS: Protection of anaesthesiologists from contaminated aerosols of COVID 19 patients during endotracheal intubation has spurred the development of barrier devices like aerosol boxes and clear transparent plastic sheets and usage of videolaryngoscopes in COVID 19 patients. However, the efficiency, feasibility and difficulties faced by anaesthesiologist while performing endotracheal intubations under barrier devices require scientific validation. This manikin-based pilot study aims to assess the laryngoscopic performances of experienced anaesthesiologists under two different barrier enclosures. METHODS AND MATERIALS: 53 anaesthesiologists (14 Consultants and 39 Senior Residents) who were undergoing an airway training module as a part of preparedness for handling the COVID 19 pandemic were recruited. Using an aerosol box over a manikin, the participants attempted intubation using a Glidescope Videolaryngoscope and Macintosh laryngoscopes (GA and MA Groups). Subsequently, intubation was attempted under a transparent plastic sheet using both laryngoscopes (GP and MP groups). Time required for intubation, first pass success rates, subjective ease of intubation and the feedback obtained from the participants were recorded and analysed. RESULTS: Time required for accomplishing successful intubation was 38.55 ± 12.16 seconds, 26.58 ± 5.73 seconds, 46.89 ± 15.23 seconds and 37.26 ± 8.71 seconds for GA, MA, GP and MP groups respectively. Time for intubation and difficulty (VAS) was least for Macintosh group with aerosol box (MA) and maximum time was taken in Glidescope group with transparent polythene drape (GP). First attempt success rate for Glidescope groups (GP and GA) were 100% and in MA and MP group was 98% and 96% respectively. Restriction in hand movement and stylet removal were the major difficulties reported. CONCLUSION: Longer intubation times were observed while using Glidescope Videolaryngoscopes with either of the two barrier devices in place compared to Macintosh laryngoscopes.