Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S).

BACKGROUND: efficacy of therapeutic cholecalciferol supplementation for severe COVID-19 is sparingly studied. OBJECTIVE: effect of single high-dose cholecalciferol supplementation on sequential organ failure assessment (SOFA) score in moderate-to-severe COVID-19. METHODS: participants with moderate to severe COVID-19 with PaO2/FiO2 ratio < 200 were randomized to 0.6 million IU cholecalciferol oral (intervention) or placebo. OUTCOMES: primary outcome was change in Day 7 SOFA score and pre-specified secondary outcomes were SOFA and 28-day all-cause mortality. RESULTS: in all, 90 patients (45 each group) were included for intention-to-treat analysis. 25(OH)D3 levels were 12 (10-16) and 13 (12-18) ng/ml (P = 0.06) at baseline; and 60 (55-65) ng/ml and 4 (1-7) ng/ml by Day 7 in vitamin D and placebo groups, respectively. The SOFA score on Day 7 was better in the vitamin D group [3 (95% CI, 2-5) versus 5 (95% CI, 3-7), P = 0.01, intergroup difference - 2 (95% CI, -4 to -0.01); r = 0.4]. A lower all-cause 28-day mortality [24% compared to 44% (P = 0.046)] was observed with vitamin D. CONCLUSIONS: single high-dose oral cholecalciferol supplementation on ICU admission can improve SOFA score at Day 7 and reduce in-hospital mortality in vitamin D-deficient COVID-19. ClinicalTrials.gov  id: NCT04952857 registered dated 7 July 2021. What is already known on this topic-vitamin D has immunomodulatory role. Observational and isolated intervention studies show some benefit in COVID-19. Targeted therapeutic vitamin D supplementation improve outcomes in severe COVID-19 is not studied in RCTs. What this study adds-high-dose vitamin D supplementation (0.6 Million IU) to increase 25(OH)D > 50 ng/ml is safe and reduces sequential organ failure assessment score, in-hospital mortality in moderate to severe COVID-19. How this study might affect research, practice or policy-vitamin D supplementation in vitamin D-deficient patients with severe COVID-19 is useful may be practiced.

Transurethral lidocaine (100 mg) bladder irrigation (TULI100) reduces the incidence of catheter related bladder discomfort in transurethral resection of bladder tumors: A randomized, double blind, controlled trial.

BACKGROUND: Transurethral resection of bladder tumors (TURBT) surgeries requires post-resection catheterization for continuous irrigation of the bladder. This indwelling catheter is associated with distressing catheter-related bladder discomfort (CRBD) and increases postoperative pain and agitation. OBJECTIVES: To prove the hypothesis that transurethral 100 mg lidocaine irrigation at the end of TURBT can reduce the frequency of moderate-to-severe postoperative CRBD. METHODS: 116 patients scheduled for TURBT were screened, 94 were recruited and completed the study. American Society of Anesthesiologists Physical Status I-II adult patients, 20-75 years of age undergoing elective TURBT surgery under general anesthesia were included. Transurethral normal saline with 0.01% lidocaine (100 mg in 1 L NS) was used for irrigation 30 min before the completion of surgery in group L, while only normal saline was used for transurethral irrigation in group N. The main outcomes were frequency of CRBD, pain and patient satisfaction at 0, 1, 2, and 6 h postoperatively. RESULTS: A total of 94 patients were analyzed in the study. The incidence of moderate-severe CRBD was significantly lower in group L as compared to group C at 0, 1, and 2 h (65.9% vs. 31.9%, p = 0.01; 31.9% vs. 10.6%, p = 0.012; 21.3% vs. 2.1%, p = 0.004, respectively). At the 6-h mark, the incidence of CRBD was lower in group L, although this did not achieve statistical significance (6.38% vs. 2.1%; p = 0.613). CONCLUSION: Irrigation with 0.01% lidocaine (100 mg) towards the end of TURBT reduces the incidence of moderate-severe CRBD by 52% and increases patient satisfaction.

Incidence & outcomes of clinically significant bleeding events in critically ill COVID-19 patients receiving Therapeutic dose AntiCoagulanTs: A retrospective cohort study (INTerACT study).

Background & objectives: The high mortality associated with the thrombotic events in hospitalized COVID-19 patients resulted in the usage of anticoagulants in varying doses. Whether high-dose anticoagulants have led to better outcomes or higher incidence of clinically significant bleeding events is debatable. Thus, this study was conducted to find the incidence of clinically significant bleeding events in moderate-to-severe COVID-19 ARDS (acute respiratory distress syndrome) patients on therapeutic anticoagulation and their outcomes. Methods: In this retrospective, single-centre study of 155 critically ill COVID-19 patients, the incidence of clinically significant bleeding was observed. Multivariate regression models were used to evaluate the association between anticoagulant regimen, coagulation and inflammatory markers with the incidence of bleeding and thrombotic events. Results: The incidence of clinically relevant non-major bleeding was 33.54 per cent (26.17-41.46%) and major bleeding was 9.03 per cent (5.02-14.69%). The anticoagulation intensity at baseline had a high odds of major bleeding when enoxaparin and dual antiplatelet therapy were used together [adjusted odds ratio OR of 434.09 (3.81-49502.95), P<0.05]. At admission, bleeders had a poorer PaO2/FiO2 ratio with more patients on invasive ventilation. At the time of bleeding, the bleeders had a higher D-dimer, ferritin, C-reactive protein and procalcitonin compared to non-bleeders. The subhazard ratio for death in bleeders was 3.35 (95% confidence interval, 1.97-5.65; P<0.001). Interpretation & conclusions: The incidence of bleeding in critically ill COVID-19 patients on therapeutic anticoagulation may increase with the severity of the disease as well as with concurrent use of dual antiplatelets. Major bleeding may also contribute to higher mortality.

Subaortic Membrane-A Savior in Large Perimembranous Ventricular Septal Defect.

Ventricular septal defects (VSD) are the most common congenital cardiac defect. Patients with large VSDs present early due to an increase in the volume load on the left ventricle and pressure load on the right ventricle. Few of them present late even without surgical intervention, due to partial restriction of perimembranous (PM) VSD, either by the septal leaflet of the tricuspid valve or by aortic valve cusp prolapse into the VSD. The authors observed a novel structure (ie, subaortic membrane in this case) restricting the large PM VSD in a 15-year-old child.

Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy.

OBJECTIVE: Regional analgesia continues to evolve with the introduction of ultrasound-guided fascial plane blocks. Erector spinae plane block (ESPB) is a novel technique gaining recent acceptability as a perioperative modality of analgesia in various thoracic and abdominal surgeries. However, literature on the use of ESPB in pediatric cardiac surgery is limited. DESIGN: A prospective, randomized, single-blind, comparative study. SETTING: Single-institution tertiary referral cardiac center. PARTICIPANTS: Eighty children with acyanotic congenital heart disease undergoing cardiac surgery through midline sternotomy. INTERVENTIONS: The subjects were allocated randomly into 2 groups: ESPB (group B, n = 40) received ultrasound-guided bilateral ESPB at the level of T3 transverse process and control (group C, n = 40) receiving no block. MEASUREMENTS AND MAIN RESULTS: The postoperative pain was assessed using Modified Objective Pain Scores (MOPS) which were evaluated at 0, 1, 2, 4, 6, 8, 10, and 12 hours after extubation. Group B demonstrated significantly reduced MOPS as compared with group C until the 10th postoperative hour (p < 0.0001), with comparable MOPS at the 12th hour. The consumption of postoperative rescue fentanyl was also significantly less in group B in comparison to group C (p < 0.0001) with a longer duration to first rescue dose requirement in group B. In addition, the group B showed lower postoperative sedation scores and intensive care unit stay in contrast to group C. CONCLUSION: Ultrasound-guided bilateral ESPB presents a simple, innovative, reliable, and effective postoperative analgesic modality for pediatric cardiac surgeries contemplated through a midline sternotomy.

Comparison of the Efficacy of Ultrasound-Guided Serratus Anterior Plane Block, Pectoral Nerves II Block, and Intercostal Nerve Block for the Management of Postoperative Thoracotomy Pain After Pediatric Cardiac Surgery.

OBJECTIVE: The aim of this study was to compare the relative efficacy of ultrasound-guided serratus anterior plane block (SAPB), pectoral nerves (Pecs) II block, and intercostal nerve block (ICNB) for the management of post-thoracotomy pain in pediatric cardiac surgery. DESIGN: A prospective, randomized, single-blind, comparative study. SETTING: Single-institution tertiary referral cardiac center. PARTICIPANTS: The study comprised 108 children with congenital heart disease requiring surgery through a thoracotomy. INTERVENTIONS: Children were allocated randomly to 1 of the 3 groups: SAPB, Pecs II, or ICNB. All participants received 3 mg/kg of 0.2% ropivacaine for ultrasound-guided block after induction of anesthesia. Postoperatively, intravenous paracetamol was used for multimodal and fentanyl was used for rescue analgesia. MEASUREMENTS AND MAIN RESULTS: A modified objective pain score (MOPS) was evaluated at 1, 2, 4, 6, 8, 10, and 12 hours post-extubation. The early mean MOPS at 1, 2, and 4 hours was similar in the 3 groups. The late mean MOPS was significantly lower in the SAPB group compared with that of the ICNB group (p < 0.001). The Pecs II group also had a lower MOPS compared with the ICNB group at 6, 8, and 10 hours (p < 0.001), but the MOPS was comparable at hour 12 (p = 0.301). The requirement for rescue fentanyl was significantly higher in ICNB group in contrast to the SAPB and Pecs II groups. CONCLUSION: SAPB and Pecs II fascial plane blocks are equally efficacious in post-thoracotomy pain management compared with ICNB, but they have the additional benefit of being longer lasting and are as easily performed as the traditional ICNB.

Correlation between duration of preoperative fasting and emergence delirium in pediatric patients undergoing ophthalmic examination under anesthesia: A prospective observational study.

BACKGROUND: Preoperative fasting in children can cause anxiety, which may ultimately lead to postoperative emergence delirium. However, no data are available whether duration of preoperative fasting correlates with postoperative emergence delirium. AIMS: The aim of this study was to identify if there is any correlation between the duration of preoperative fasting and emergence delirium in children undergoing ophthalmic examination under anesthesia. METHODS: In this prospective observational study, 100 children between the age group 2-6 years of American Society of Anesthesiologists physical status I or II, scheduled for examination of the eye under general anesthesia with sevoflurane were recruited. Data regarding preoperative fasting was recorded and presence of emergence delirium was assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale at 5 minute interval till 30 minutes from the time of leaving the operation theater. No premedication was used in any patients but parental presence was allowed in all of them. RESULTS: Mean (standard deviation) duration of fasting to clear liquid was 6.3 (1.7) hrs. Twenty-four children (24%) had at least 1 recorded PAED score >10 at any time point in the postoperative period. PAED scores at 15 and 25 minutes were significantly correlated with duration of fasting (r2 [95% CI] = .24 [0.04, 0.41], P = .02, Pearsons's correlation and r2 [95% CI] = .23 [0.04, 0.41], P = .02, Pearsons's correlation, respectively). No correlation has been found between duration of fasting and blood glucose level (r2 [95% CI] = -.05 [-0.24, 0.15], P = .65, Pearsons's correlation) between fasting blood glucose and PAED score at any time point. CONCLUSION: Increased preoperative fasting duration may be a risk factor for postoperative emergence delirium in children undergoing ophthalmic examination under general anesthesia.

Surgical correction of total anomalous pulmonary venous connection to persistent left-sided superior vena cava: a case report.

Background: Total anomalous pulmonary venous connection (TAPVC) to left superior vena cava (LSVC) is an extremely rare congenital heart disease, and its surgical management is very challenging. Case summary: We report one such case of a 5-year-old south Asian male with double outlet right ventricle and unbalanced atrioventricular canal defect, where all the pulmonary veins were found opening into LSVC, which was then opening into the left side of the common atrium. Intraoperatively, the LSVC was transected just below the left internal jugular vein and left subclavian vein junction and left-sided bidirectional Glenn shunt done using 8 mm Dacron tube graft. Pulmonary veins were left draining through the LSVC into the common atrium. Right-sided Glenn shunt was completed as usual. Currently, the patient is year and half post-surgery and is doing well; school going on par with the peer group maintaining a room air saturation of 87%. Discussion: Here, we report a successful surgical correction of TAPVC to LSVC in a child with univentricular physiology, however due to the paucity of data and rarity of such cases, optimal surgical management is yet to be defined.

Olanzapine versus standard antiemetic prophylaxis for the prevention of post-discharge nausea and vomiting after propofol-based general anaesthesia: A randomised controlled trial.

Background and Aims: Post-discharge nausea and vomiting (PDNV) is a pertinent problem in patients undergoing ambulatory surgery. The objective of this study was to assess the efficacy of the novel drug olanzapine, which has proved its efficiency in patients undergoing highly emetogenic chemotherapy for PDNV prevention. Methods: This randomised controlled trial recruited 106 adult patients (18-65 years) undergoing highly emetogenic daycare surgeries with propofol-based general anaesthesia (GA). Group O received preoperative oral olanzapine 10 mg, and Group C, acting as a control, received 8 mg of intravenous dexamethasone and 4 mg of ondansetron intraoperatively. The primary outcome was nausea (numeric rating scale >3) and/or vomiting 24 h after discharge. Secondary outcomes included nausea and vomiting in the post-anaesthesia care unit (PACU), severe nausea, vomiting and side effects. Normality was assessed using the Shapiro-Wilk test, and the independent samples t-test or the Mann-Whitney U test was used to compare continuous variables. Fisher's exact test was used to assess any non-random associations between the categorical variables. Results: The incidence and severity of postoperative nausea and vomiting were similar in both groups within PACU (four patients experienced nausea and vomiting, three had severe symptoms in Group O, P = 0.057) and in the post-discharge period (three patients in Group O had nausea and vomiting compared to five patients in Group C, of which four were severe, P = 0.484). The side effects (sedation, dizziness, and light-headedness) were comparable between the two groups. Conclusion: A single preoperative oral olanzapine can be an effective alternative to standard antiemetic prophylaxis involving dexamethasone and ondansetron for preventing PDNV in highly emetogenic daycare surgeries with propofol-based GA.

Clinical outcomes of corneal neurotization using sural nerve graft in neurotrophic keratopathy.

OBJECTIVE: To evaluate the efficacy of corneal neurotisation using sural nerve graft coaptation of the contralateral supratrochlear nerve in unilateral neurotrophic keratopathy and corneal anesthesia. Corneal neuralization has emerged as a potential option in the treatment of neurotropic keratopathy, however not free from the predicament. We evaluated the long-term outcome of corneal neurotisation in the treatment of unresponsive unilateral neurotropic keratopathy using surgical variations to mimic and expedient the surgical procedure. METHODS: A Prospective interventional study involving patients with unilateral neurotrophic keratopathy (NK) who did not respond to medical measures was conducted. The study parameters evaluated were best-corrected visual acuity improvement, ocular surface evaluation parameters [tear break-up time (TBUT), Schirmer's 1, and ocular surface staining scores (corneal and conjunctival staining)], central corneal sensation (Cochet Bonnet esthesiometer), sub-basal nerve fiber length (SBNFL), and sub-basal nerve fiber density (SBNFD) determined by central confocal microscopy at recruitment and during follow-up at 1-month, 3-month, 6-month, 9-month and 12-month respectively, following corneal neurotization. RESULTS: Eleven eyes of 11 patients with unilateral neurotrophic keratopathy (NK) who underwent corneal neurotisation were studied. The mean follow-up was 10.09±2.31months (range, 6-12). Mean best corrected visual acuity in log MAR at baseline, 1.35±0.52 improved significantly to 1.06±0.76 (P = 0.012) at 3 months and continued to 0.55±0.60 (P = 0.027) at 12 months. There was a significant reduction in NK grade severity and improvement in the ocular surface as early as 1 month, and central corneal sensations (P = 0.024) as soon as 3 months. Mean corneal SBNF improved from 3.12±1.84 mm/mm2 to 4.49±1.88 at 1 month (P = 0.008), 13.31±3.61 mm/mm2 (P = 0.028) at 12 months. Mean central corneal SBNFD evident at 6 months was 1.83±2.54no/mm2 (P = 0.018) and 4.90±3.12no/mm2 (P = 0.028) at 12 months. CONCLUSION: This study substantiates the routine practice of corneal neurotisation by simplifying the intricacies observed during the procedure.

Epicardial pacemaker insertion in a preterm very low birth weight neonate - An anaesthetic challenge.

Congenital complete heart block (CCHB) has an incidence of one in 20,000 live births and carries a 20% risk of mortality. The hemodynamic instability due to bradycardia and asystole due to the increasing metabolic demands can be avoided by appropriate antenatal planning, timely delivery and initiation of medical treatment and early pacemaker insertion. In this report, we discuss the anaesthetic challenges of permanent epicardial pacemaker insertion with good outcomes in a 32-week gestational age 1380 grams neonate within a few hours of birth.

Evaluation of lacrimal duct probing in adults with 0.02% and 0.04% mitomycin-C in primary acquired nasolacrimal duct obstruction: A randomized comparative pilot study.

PURPOSE: The purpose of the study is to evaluate the safety and efficacy of adjunctive use of mitomycin-C (MMC) using two different concentrations 0.2 mg/ml and 0.4 mg/ml for lacrimal duct probing to treat the nasolacrimal duct obstruction (NLDO) in adults. SUBJECTS AND METHODS: Prospective, an interventional comparative randomized pilot study of lacrimal duct probing conducted in the two study groups 0.02% MMC group (n = 30) and 0.04% MMC group (n = 30) in confirmed primary acquired NLDO of <1-year duration. Patency of lacrimal duct probing confirmed by syringing was compared at 1, 3, and 6-month follow-up in the two study groups, and corresponding subjective improvement of watering was appraised according to Kraft and Crawford grading. RESULTS: Patency of lacrimal duct probing in 0.02% MMC versus 0.04% MMC group was 66.66%/73.33% (P = 0.71) at 1 month, 46.66%/66.66% (P = 0.09) at 3 months and 46.66%/66.66% (P = 0.03) at 6-month follow-up, respectively. Subjective improvement of watering (no watering and mild watering) observed in 0.02% MMC versus 0.04% MMC group was 46.66%/73.33% (P = 0.03), at 1 month, 66.66%/83.33% (P = 0.13) at 3 months and 56.66%/73.33% (P = 0.17) at 6-month follow-up. CONCLUSION: Adult lacrimal duct probing with 0.04% MMC was associated with significant higher objective success rate than adult lacrimal duct probing with 0.02% MMC, without added concurrently side effects.

Aneurysmal Oscillation of the Capnogram: A Case Report.

Variations in the alveolar plateau phase of the capnogram are often confused with spontaneous breathing efforts in an intubated patient. The oscillations in the capnogram due to a large ascending thoracic aneurysm are a separate entity from cardiogenic oscillations, and can be an indicator of underlying bronchial or lung compression.

High-Dose Dexamethasone Versus Tocilizumab in Moderate to Severe COVID-19 Pneumonia: A Randomized Controlled Trial.

Background and objectives Recent randomized controlled trials (RCTs) have indicated potential therapeutic benefits with high-dose dexamethasone (HDD) or tocilizumab (TCZ) plus standard care in moderate to severe coronavirus disease 2019 (COVID-19) with acute respiratory distress syndrome (ARDS). No study has compared these two against each other. We aimed to compare the efficacy and safety of HDD against TCZ in moderate to severe COVID-ARDS. Methods Patients admitted with moderate to severe COVID-19 ARDS with clinical worsening within 48 hours of standard care were randomly assigned to receive either HDD or TCZ plus standard care. The primary outcome was ventilator-free days (VFDs) at 28 days. The main secondary outcomes were 28-day all-cause mortality and the incidence of adverse events. Our initial plan was to perform an interim analysis of the first 42 patients. Results VFDs were significantly lower in the HDD arm (median difference: 28 days; 95% confidence interval (CI): 19.35-36.65; Cohen's d = 1.14;p < 0.001). We stopped the trial at the first interim analysis due to high 28-day mortality in the HDD arm (relative risk (RR) of death: 6.5; p = 0.007; NNT (harm) = 1.91). The incidence of secondary infections was also significantly high in the HDD arm (RR: 5.5; p = 0.015; NNT (harm) = 2.33). Conclusions In our study population, HDD was associated with a very high rate of mortality and adverse events. We would not recommend HDD to mitigate the cytokine storm in moderate to severe COVID-19 ARDS. TCZ appears to be a much better and safer alternative.

Pulmonary Function, Mental and Physical Health in Recovered COVID-19 Patients Requiring Invasive Versus Non-invasive Oxygen Therapy: A Prospective Follow-Up Study Post-ICU Discharge.

Background Survivors of COVID-19 pneumonia may have residual lung injury and poor physical and mental health even after discharge. We hypothesized that COVID-19 severe acute respiratory distress syndrome (ARDS) patients needing mechanical ventilation may be at a greater risk of deterioration in pulmonary function, mental health, and quality of life (QOL). This study analyses the differences in pulmonary function, mental health, and QOL after recovery, in patients having received non-invasive oxygen therapy versus invasive mechanical ventilation during ICU stay. Methods Patients aged >18 years, who had completed 3 months post ICU discharge, with moderate to severe COVID-19 ARDS, were consecutively enrolled from May 1 to July 31, 2021. Patients were allocated into Group A - having required high flow nasal cannula (HFNC)/non-invasive ventilation (NIV) and Group B - having received invasive mechanical ventilation. Pulmonary function tests, 6-minute walk test (6-MWT), and health-related quality of life were compared. Results Of the 145 eligible patients, 31 were lost to follow-up and 21 died. Seventy-four patients were allocated into Groups A (57 patients) and B (17 patients). In Group A, abnormal forced expiratory volume in first second (FEV1), forced vital capacity (FVC), forced expiratory flow in mid-half of FVC (FEF25-75), and peak expiratory flow rate (PEFR) values were obtained in 27 (47.37%), 43 (75.44%), 11 (19.3%), and 25 (43.86%) patients, and in Group B, in 13 (76.47%), 17 (100%), 1 (5.88%), and 8 (47%) patients, respectively. No patient had abnormal FEV1/FVC. All Group B patients had a restrictive pattern in spirometry as compared to 77% in Group A. Group B had a lower arterial partial pressure of oxygen (PaO2) (p=0.0019), % predicted FVC (p<0.0001), % predicted FEV1 (p=0.001), and 6-MWT distance (p<0.001). The physical component score in the short-form survey 12 questionnaire was higher in group A, p<0.001, whereas the mental component score was comparable. Conclusions Patients requiring invasive mechanical ventilation (MV) have a greater risk of impaired pulmonary function and reduced QOL post-ICU discharge. This warrants a greater need for following these patients for better rehabilitation.

Preparing Intensive Care Unit in Resource-Constraint Setting Amid COVID-19 Pandemic: Our Experience and Review.

COVID-19 pandemic is an emerging, rapidly evolving public health emergency where a nation's health-care system can face a marked surge in demand for intensive care unit (ICU) beds and organ support. In regions with insufficient medical resources, it may further aggravate the existing shortage, limiting an ICU's ability to provide the normal standard of care. It can present ethically or legally demanding questions about how to prioritize the allocation of life-saving medical resources. In developing countries like India, still many hospitals are challenged by competing priorities and remain underprepared. In the wake of COVID-19 pandemic, to guide the intensive care disaster planners in regions with low resources and to ensure ICU readiness, this review shares our experience and strategies for preparing ICU with existing and alternative resources, focusing on space, equipment, and health-care workers' safety and training.