View Score: An early warning score to detect possible complications among COVID-19 patients.

Introduction: Understanding pulmonary function at various phases after coronavirus disease 2019 (COVID-19) infection is critical for determining the exact pathophysiological mechanism of COVID-19. Research Question: What is the correlation between spirometry indices and clinical indicators in COVID-19 patients over a 6-week follow-up? Objectives: 1) To assess deterioration or improvement in spirometry parameters including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and ratio FEV1/FVC in COVID-19 patients. 2) To study the correlation between FVC, FEV1, and FEV1/FVC with oxygen saturation and clinical findings. Materials and Methods: A prospective observational study was conducted for a 6-week period among 25, COVID-19 patients who were either asymptomatic or mildly symptomatic. Each patient received a home-use-connected spirometer-SpiroPRO®, a pulse oximeter, and a thermometer from Briota Technologies Pvt Ltd. (BRIOTA). Patients and healthcare professionals were given training for performing spirometry twice a day as well as access to mobile apps was provided. Spirometry indices, patient symptoms, and vital statistics were used to calculate the VIEW™ score using machine learning algorithms. Result: The Bland-Altman plots showed that FEV1 reduced slightly up to 21-28 days and comes back to normal around 42 days. VIEW™ score increased up to day 21 and then decreased toward day 42. An increase in VIEW™ score increases the risk of COVID-19 complications. VIEW™ score and FEV1 showed a significant correlation. Conclusion: Home-based spirometry acts as an effective tool for COVID-19 patients to predict lung complications and also promote self-monitoring thereby reducing the burden on the health system.

Rhabdomyolysis-Induced Acute Kidney Injury Treated with Medium Cut-Off Membrane: A Case Report.

Acute kidney injury can complicate rhabdomyolysis in 10-40% patients. Myoglobinuria and elevated creatine kinase (CK) form the basis of diagnosis. When associated with azotemia and/or oliguria, intermittent hemodialysis is a treatment option. 31-year-old young man came with lower limb pain after doing 800 sit ups. At the presentation, blood pressure was high, serum creatinine was 15.7mg/dl and creatine kinase(CK)>20000 IU/L. Intermittent dialysis was initiated. He developed posterior reversible encephalopathy syndrome, generalized tonic clonic convulsions and a further rise in CK. He underwent extracorporeal removal of myoglobin with medium cut-off (MCO) membrane. After 3 sessions with MCO membrane, myoglobin and CK levels reduced. He was transitioned to conventional dialysis and discharged in a stable condition with complete renal recovery. Medium cut-off membrane effectively removes circulating myoglobin without significant albumin loss and is cost effective.

Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia.

PURPOSE: We assessed long-term outcomes of dexamethasone 12 mg versus 6 mg given daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia. METHODS: We assessed 180-day mortality and health-related quality of life (HRQoL) using EuroQoL (EQ)-5D-5L index values and EQ visual analogue scale (VAS) in the international, stratified, blinded COVID STEROID 2 trial, which randomised 1000 adults with confirmed COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 26 hospitals in Europe and India. In the HRQoL analyses, higher values indicated better outcomes, and deceased patients were given a score of zero. RESULTS: We obtained vital status at 180 days for 963 of 982 patients (98.1%) in the intention-to-treat population, EQ-5D-5L index value data for 922 (93.9%) and EQ VAS data for 924 (94.1%). At 180 days, 164 of 486 patients (33.7%) had died in the 12 mg group versus 184 of 477 (38.6%) in the 6 mg group [adjusted risk difference - 4.3%; 99% confidence interval (CI) - 11.7-3.0; relative risk 0.89; 0.72-1.09; P = 0.13]. The adjusted mean differences between the 12 mg and the 6 mg groups in EQ-5D-5L index values were 0.06 (99% CI - 0.01 to 0.12; P = 0.10) and in EQ VAS scores 4 (- 3 to 10; P = 0.22). CONCLUSION: Among patients with COVID-19 and severe hypoxaemia, dexamethasone 12 mg compared with 6 mg did not result in statistically significant improvements in mortality or HRQoL at 180 days, but the results were most compatible with benefit from the higher dose.

Noninvasive Respiratory Assist Devices in the Management of COVID-19-related Hypoxic Respiratory Failure: Pune ISCCM COVID-19 ARDS Study Consortium (PICASo).

Objective: To determine whether high-flow nasal oxygen (HFNO) or noninvasive ventilator (NIV) can avoid invasive mechanical ventilation (IMV) in COVID-19-related acute respiratory distress syndrome (ADRS), and the outcome predictors of these modalities. Design: Multicenter retrospective study conducted in 12 ICUs in Pune, India. Patients: Patients with COVID-19 pneumonia who had PaO2/FiO2 ratio <150 and were treated with HFNO and/or NIV. Intervention: HFNO and/or NIV. Measurements: The primary outcome was to assess the need of IMV. Secondary outcomes were death at Day 28 and mortality rates in different treatment groups. Main results: Among 1,201 patients who met the inclusion criteria, 35.9% (431/1,201) were treated successfully with HFNO and/or NIV and did not require IMV. About 59.5% (714/1,201) patients needed IMV for the failure of HFNO and/or NIV. About 48.3, 61.6, and 63.6% of patients who were treated with HFNO, NIV, or both, respectively, needed IMV. The need of IMV was significantly lower in the HFNO group (p <0.001). The 28-day mortality was 44.9, 59.9, and 59.6% in the patients treated with HFNO, NIV, or both, respectively (p <0.001). On multivariate regression analysis, presence of any comorbidity, SpO2 <90%, and presence of nonrespiratory organ dysfunction were independent and significant determinants of mortality (p <0.05). Conclusions: During COVID-19 pandemic surge, HFNO and/or NIV could successfully avoid IMV in 35.5% individuals with PO2/FiO2 ratio <150. Those who needed IMV due to failure of HFNO or NIV had high (87.5%) mortality. How to cite this article: Jog S, Zirpe K, Dixit S, Godavarthy P, Shahane M, Kadapatti K, et al. Noninvasive Respiratory Assist Devices in the Management of COVID-19-related Hypoxic Respiratory Failure: Pune ISCCM COVID-19 ARDS Study Consortium (PICASo). Indian J Crit Care Med 2022;26(7):791-797.

Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial.

PURPOSE: We compared dexamethasone 12 versus 6 mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial. In the primary, conventional analyses, the predefined statistical significance thresholds were not reached. We conducted a pre-planned Bayesian analysis to facilitate probabilistic interpretation. METHODS: We analysed outcome data within 90 days in the intention-to-treat population (data available in 967 to 982 patients) using Bayesian models with various sensitivity analyses. Results are presented as median posterior probabilities with 95% credible intervals (CrIs) and probabilities of different effect sizes with 12 mg dexamethasone. RESULTS: The adjusted mean difference on days alive without life support at day 28 (primary outcome) was 1.3 days (95% CrI -0.3 to 2.9; 94.2% probability of benefit). Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90. Probabilities of benefit on days alive without life support and days alive out of hospital at day 90 were 85 and 95.7%, respectively. Results were largely consistent across sensitivity analyses, with relatively low probabilities of clinically important harm with 12 mg on all outcomes in all analyses. CONCLUSION: We found high probabilities of benefit and low probabilities of clinically important harm with dexamethasone 12 mg versus 6 mg daily in patients with COVID-19 and severe hypoxaemia on all outcomes up to 90 days.

Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial.

Importance: A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective: To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions: Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days). Results: Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). Conclusions and Relevance: Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.

Characteristics of COVID-19 Patients Admitted to a Tertiary Care Hospital in Pune, India and Predictors of Requirement for Intensive Care Treatment.

OBJECTIVES: 1. To study associations of severity of COVID-19 disease with clinical features and laboratory markers. 2. To develop a model to predict the need for ICU treatment. METHODS: This is an analysis of clinical course in 800 consecutive patients from a dedicated COVID-19 tertiary care hospital in Pune, India (8th April to 15th June 2020). We obtained clinical and laboratory information, severity grading and progress from hospital records. We studied associations of these characteristics with need for ICU management. We developed a predictive model of need for ICU treatment among first 500 patients and tested its sensitivity and specificity in the following 300 patients. RESULTS: Average age was 41 years, 16% were 20 years of age, 55% were male, 50% were asymptomatic and 16% had at least one comorbidity. Using MoHFW India severity guidelines, 73% patients had mild, 6% moderate and 20% severe disease. Severity was associated with higher age, symptomatic presentation, elevated neutrophil and reduced lymphocyte counts and elevated inflammatory markers. Seventy-seven patients needed ICU treatment: they were older (56 years), more symptomatic and had lower SpO2 and abnormal chest X-ray and deranged hematology and biochemistry at admission. A model trained on the first 500 patients, using above variables predicted need for ICU treatment with sensitivity 80%, specificity 88% in subsequent 300 patients; exclusion of expensive laboratory tests (Ferritin, C- Reactive Protein) did not affect accuracy. CONCLUSION: In the early phase of COVID- 19 pendemic, a significant proportion of hospitalized patients were young and asymptomatic. Need for ICU treatment was predicted by simple measures including higher age, symptomatic onset, low SpO2 and abnormal chest X-ray. We propose a simple model for referring patients for treatment at specialized COVID-19 hospitals.

Higher vs Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: Protocol for a secondary Bayesian analysis.

BACKGROUND: Coronavirus disease 2019 (COVID-19) can lead to severe hypoxic respiratory failure and death. Corticosteroids decrease mortality in severely or critically ill patients with COVID-19. However, the optimal dose remains unresolved. The ongoing randomised COVID STEROID 2 trial investigates the effects of higher vs lower doses of dexamethasone (12 vs 6 mg intravenously daily for up to 10 days) in 1,000 adult patients with COVID-19 and severe hypoxia. METHODS: This protocol outlines the rationale and statistical methods for a secondary, pre-planned Bayesian analysis of the primary outcome (days alive without life support at day 28) and all secondary outcomes registered up to day 90. We will use hurdle-negative binomial models to estimate the mean number of days alive without life support in each group and present results as mean differences and incidence rate ratios with 95% credibility intervals (CrIs). Additional count outcomes will be analysed similarly and binary outcomes will be analysed using logistic regression models with results presented as probabilities, relative risks and risk differences with 95% CrIs. We will present probabilities of any benefit/harm, clinically important benefit/harm and probabilities of effects smaller than pre-defined clinically minimally important differences for all outcomes analysed. Analyses will be adjusted for stratification variables and conducted using weakly informative priors supplemented by sensitivity analyses using sceptic priors. DISCUSSION: This secondary, pre-planned Bayesian analysis will supplement the primary, conventional analysis and may help clinicians, researchers and policymakers interpret the results of the COVID STEROID 2 trial while avoiding arbitrarily dichotomised interpretations of the results. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04509973; EudraCT: 2020-003363-25.

Higher vs lower doses of dexamethasone in patients with COVID-19 and severe hypoxia (COVID STEROID 2) trial: Protocol and statistical analysis plan.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in millions of deaths and overburdened healthcare systems worldwide. Systemic low-dose corticosteroids have proven clinical benefit in patients with severe COVID-19. Higher doses of corticosteroids are used in other inflammatory lung diseases and may offer additional clinical benefits in COVID-19. At present, the balance between benefits and harms of higher vs. lower doses of corticosteroids for patients with COVID-19 is unclear. METHODS: The COVID STEROID 2 trial is an investigator-initiated, international, parallel-grouped, blinded, centrally randomised and stratified clinical trial assessing higher (12 mg) vs. lower (6 mg) doses of dexamethasone for adults with COVID-19 and severe hypoxia. We plan to enrol 1,000 patients in Denmark, Sweden, Switzerland and India. The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28. Secondary outcomes include serious adverse reactions at day 28; all-cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health-related quality of life at day 180. The primary outcome will be analysed using the Kryger Jensen and Lange test adjusted for stratification variables and reported as adjusted mean differences and median differences. The full statistical analysis plan is outlined in this protocol. DISCUSSION: The COVID STEROID 2 trial will provide evidence on the optimal dosing of systemic corticosteroids for COVID-19 patients with severe hypoxia with important implications for patients, their relatives and society.

Initial Experience of Critically Ill Patients with COVID-19 in Western India: A Case Series.

BACKGROUND: The novel coronavirus, named SARS-CoV-2, was first described in December 2019 as a cluster of pneumonia cases in Wuhan, China. It has since been declared a pandemic, with substantial mortality. MATERIALS AND METHODS: In our case series, we describe the clinical presentation, characteristics, and outcomes of our initial experience of managing 24 critically ill COVID-19 patients at a designated COVID-19 ICU in Western India. RESULTS: Median age of the patients was 54 years, and 58% were males. All patients presented with moderate to severe acute respiratory distress syndrome (ARDS); however, only 37.5% failed trials of awake proning and required mechanical ventilation. Patients who received mechanical ventilation typically matched the H-phenotype of COVID-19 pneumonia, and 55.5% of these patients were successfully extubated. CONCLUSION: The most common reason for ICU admission in our series of 24 patients with severe COVID-19 was hypoxemic respiratory failure, which responded well to conservative measures such as awake proning and oxygen supplementation. Mortality in our case series was 16.7%. HOW TO CITE THIS ARTICLE: Shukla U, Chavali S, Mukta P, Mapari A, Vyas A. Initial Experience of Critically Ill Patients with COVID-19 in Western India: A Case Series. Indian J Crit Care Med 2020;24(7):509-513.

Cronkhite Canada syndrome complicated by pulmonary embolism-A case report.

INTRODUCTION: Cronkhite Canada Syndrome (CCS) is a rare syndrome, described in 1955 by Americans, Leonard Wolsey Cronkhite and Wilma Jeanne Canada in the New England Journal of Medicine [1]. About 450 cases have been reported. Complications, like malignant transformation, unprovoked thromboembolism is known. Since there is wide variability in medical presentation, no definitive diagnostic and treatment protocol s have been set. The mortality remains at 55%. CASE PRESENTATION: We report a case of a 50 year old male patient presenting with diarrhea, weight loss, abdominal pain, ectodermal features. His upper (UGI) and lower Gastrointestinal (LGI) endoscopy showed multiple polypoidal and carpet like lesions in fundus, body and antrum of stomach. Videocolonoscopy showed multiple sessile and pedunculated polyps. Multiple biopsies were taken, proving malignancy. Because of poor nutrition, total parenteral nutrition was given for four weeks. After nutritional optimization, he underwent laparoscopic assisted subtotal colectomy. His post-operative course was complicated by the occurrence of pulmonary embolism and anastomotic leak. DISCUSSION: CCS is an ailment of unknown pathophysiology. Considering what is known so far, patients suffering from CCS are at highest risk of thromboembolic episodes. This seems to be irrespective of surgical intervention. Patients of CCS should have thromboembolic prophylaxis started as soon as a diagnosis is made. They should have thrombophilia profile, fibrinogen level and Factor 8 tested before any intervention is planned. CONCLUSION: If CCS presents with a surgical indication, namely malignancy, the patient should be categorized as highest risk for thromboembolic complications and both mechanical and pharmacological prophylaxis be instituted.

Hand hygiene compliance among healthcare workers in an accredited tertiary care hospital.

AIM: We are using multimodal technique to improve hand hygiene (HH) compliance among all health care staff for the past 1-year. This cross-sectional observational study was conducted in the surgical ICU to assess adherence to HH among nurses and allied healthcare workers, at the end of the training year. MATERIALS AND METHODS: This was a cross-sectional observational study using direct observation technique. A single observer collected all HH data. During this analysis, 1500 HH opportunities were observed. HH compliance was tested for all 5 moments as per WHO guidelines. RESULTS: Overall compliance as per WHO Guidelines was 78%. Nurses had an adherence rate of 63%; allied staff adherence was 86.5%. Compliance was 93% after patient contact versus 63% before patient contact. Nurses'compliance before aseptic procedures was lowest at 39%. 92% staff was aware of the facts viz. Diseases prevented by hand washing, ideal duration of HH, reduction of health care associated infections, etc. CONCLUSION: After 1-year of aggressive multimodal intervention in improving HH compliance, we have an overall compliance of 78%. It implies that sustained performance and compliance to HH can be ensured by ongoing training. Direct observation remains a widely used, easily reproducible method for monitoring compliance.

Traumatic subclavian arterial thrombosis presenting with cerebral infarct--a case report.

Subclavian artery thrombosis is a rare complication of sternoclavicular fractures. Also, cerebral infarcts caused by subclavian artery thrombosis, post trauma, is very unusual. We report the case of a 49 year-old female patient presenting with traumatic subclavian arterial thrombosis and cerebral infarction secondary to a fractured manubrium with posteriorly displaced right clavicle and retrograde thromboembolisation.