A multicentre, double-blind, placebo-controlled randomized trial of Mycobacterium w in critically ill patients with COVID-19 (ARMY-2).

BACKGROUND: Mycobacterium w (Mw), an immunomodulator, resulted in better clinical status in severe coronavirus infectious disease 19 (COVID-19) but no survival benefit in a previous study. Herein, we investigate whether Mw could improve clinical outcomes and survival in COVID-19. MATERIALS AND METHODS: In a multicentric, randomized, double-blind, parallel-group, placebo-controlled trial, we randomized hospitalized subjects with severe COVID-19 to receive either 0.3 mL/day of Mw intradermally or a matching placebo for three consecutive days. The primary outcome was 28-day mortality. The co-primary outcome was the distribution of clinical status assessed on a seven-point ordinal scale ranging from discharged (category 1) to death (category 7) on study days 14, 21, and 28. The key secondary outcomes were the change in sequential organ failure assessment (SOFA) score on days 7 and 14 compared to the baseline, treatment-emergent adverse events, and others. RESULTS: We included 273 subjects (136 Mw, 137 placebo). The use of Mw did not improve 28-day survival (Mw vs. placebo, 18 [13.2%] vs. 12 [8.8%], P = 0.259) or the clinical status on days 14 (odds ratio [OR], 1.33; 95% confidence intervals [CI], 0.79-2.3), 21 (OR, 1.49; 95% CI, 0.83-2.7) or 28 (OR, 1.49; 95% CI, 0.79-2.8) between the two study arms. There was no difference in the delta SOFA score or other secondary outcomes between the two groups. We observed higher injection site reactions with Mw. CONCLUSION: Mw did not reduce 28-day mortality or improve clinical status on days 14, 21 and 28 compared to placebo in patients with severe COVID-19. [Trial identifier: CTRI/2020/04/024846].

Peri-Intubation Hypoxia After Delayed Versus Rapid Sequence Intubation in Critically Injured Patients on Arrival to Trauma Triage: A Randomized Controlled Trial.

BACKGROUND: Critically injured patients who are agitated and delirious on arrival do not allow optimal preoxygenation in the emergency area. We investigated whether the administration of intravenous (IV) ketamine 3 minutes before administration of a muscle relaxant is associated with better oxygen saturation levels while intubating these patients. METHODS: Two hundred critically injured patients who required definitive airway management on arrival were recruited. The subjects were randomized as delayed sequence intubation (group DSI) or rapid sequence intubation (group RSI). In group DSI, patients received a dissociative dose of ketamine followed by 3 minutes of preoxygenation and paralysis using IV succinylcholine for intubation. In group RSI, a 3-minute preoxygenation was performed before induction and paralysis using the same drugs, as described conventionally. The primary outcome was incidence of peri-intubation hypoxia. Secondary outcomes were first-attempt success rate, use of adjuncts, airway injuries, and hemodynamic parameters. RESULTS: Peri-intubation hypoxia was significantly lower in group DSI (8 [8%]) compared to group RSI (35 [35%]; P = .001). First-attempt success rate was higher in group DSI (83% vs 69%; P = .02). A significant improvement in mean oxygen saturation levels from baseline values was seen in group DSI only. There was no incidence of hemodynamic instability. There was no statistically significant difference in airway-related adverse events. CONCLUSIONS: DSI appears promising in critically injured trauma patients who do not allow adequate preoxygenation due to agitation and delirium and require definitive airway on arrival.

Tracheal intubation practices and adverse events in trauma victims on arrival to trauma triage: A single centre prospective observational study.

Background and Aims: Trauma is one of the leading causes of global disease burden. Data on airway management in trauma patients from developing countries, particularly India is sparse. Hence, we planned a prospective observational study to assess the airway management practice patterns and associated complications. Methods: The study was conducted in trauma triage of a tertiary care hospital. Data was collected on all tracheal intubations occurring in trauma victims requiring definitive airway control, a detailed proforma including patient details, mode of injury, drugs used, intubation procedure, and complications were filled out for each patient. Results: We observed that the airway in trauma patients was primarily managed by non-anaesthesia speciality residents (426 patients); anaesthesia residents were primarily called for deferred or difficult intubations. The first attempt success rate of intubation by anaesthesia residents was significantly higher than speciality residents (P = 0.0001; 95% CI 9.02-24.66). Non-anaesthesia residents used midazolam in varying doses (3-12 mg) for intubation, whereas, rapid sequence intubation was the most common technique used by anaesthesia residents. Airway injuries were the most frequent complication observed in 32.8% of patients intubated by specialty residents compared to 5.9% of patients intubated by anaesthesia residents. Conclusion: The trauma triage is a high-volume area for frequent tracheal intubations which are manned by non-anaesthesia speciality teams. A number of factors related to the patient, staff, availability of airway equipment and unfavourable surroundings impact airway management and may explain the high incidence of airway complications, such as airway injuries in these trauma victims.

Colonization of the central venous catheter by Stenotrophomonas maltophilia in an ICU setting: An impending outbreak managed in time.

BACKGROUND: Stenotrophomonas maltophiliacauses opportunistic infections in immunocompromised and patients in intensive care units (ICUs). An outbreak of S. maltophilia in ICU is described which highlights the importance of the risk of infection from contaminated medical devices and suction fluids in ventilated patients. METHODS: The investigation of the outbreak was carried out. Environmental sampling was done. This was followed by MALDI-TOF MS typing and recA gene-based-phylogeny. RESULTS: In February, S. maltophilia was reported from the central line blood of six patients from ICU within a span of two weeks. The peripheral line blood cultures were sterile in all patients. Relevant environmental sampling of the high-touch surface and fluids revealed S. maltophilia strains in normal saline used for suction and in the inspiratory circuit of two patients. The isolated strains from patients and environment (inspiratory fluid) showed a minimum of 95.41% recA gene sequence identity between each other. Strict cleaning and disinfection procedures were followed. Continuous surveillance was done and no further case of S. maltophilia was detected. Timely diagnosis and removal of central line prevented development of central-line associated blood stream infection. CONCLUSION: This outbreak report illustrates that environmental sources like suction fluid and normal saline could be the source of S. maltophilia in ICU patients.

Computed tomography chest in COVID-19: When & why?

Computed tomography (CT) of the chest plays an important role in the diagnosis and management of coronavirus disease 2019 (COVID-19), but it should not be used indiscriminately. This review provides indications of CT chest in COVID-19 suspect, positive and recovered patients based on the current scientific evidence and our personal experience. CT chest is not indicated as a routine screening modality due to its poor sensitivity and specificity. However, it is useful in a small subset of COVID-19 suspects who test negative on reverse transcription-polymerase chain reaction (RT-PCR) with normal/indeterminate chest X-ray (CXR) but have moderate-to-severe respiratory symptoms and high index of clinical suspicion. CT chest is not indicated in every RT-PCR-positive patient and should be done only in specific clinical scenarios, where it is expected to significantly contribute in the clinical management such as COVID-19 patients showing unexplained clinical deterioration and/or where other concurrent lung pathology or pulmonary thromboembolism needs exclusion. Serial CXR and point-of-care ultrasound are usually sufficient to evaluate the progression of COVID-19 pneumonia. CT chest is also indicated in COVID-19-positive patients with associated co-morbidities (age >65 yr, diabetes, hypertension, obesity, cardiovascular disease, chronic respiratory disease, immune-compromise, etc.) who, despite having mild symptoms and normal/indeterminate CXR, record oxygen saturation of <93 per cent at rest while breathing room air or de-saturate on six-minute walk test. Finally, CT chest plays a crucial role to rule out lung fibrosis in patients recovered from COVID-19 infection who present with hypoxia/impaired lung function on follow up. In conclusion, though CT chest is an indispensable diagnostic tool in COVID-19, it should be used judiciously and only when specifically indicated.