ABSTRACT
The relationship between chronic liver disease and respiratory symptoms and hypoxia is well recognized. Over the last century, three pulmonary complications specific to chronic liver disease (CLD) have been characterized: hepatopulmonary syndrome, portopulmonary hypertension, and hepatic hydrothorax. Apart from that coexisting pulmonary disease like chronic obstructive lung disease and interstitial lung disease also complicate the outcomes after liver transplantation (LT). Assessment for evaluation of underlying pulmonary disorders is essential to improve outcomes in patients with CLD, posted for LT. This consensus guideline of the Liver Transplant Society of India (LTSI) provides a comprehensive review of pulmonary issues in CLD, related and unrelated to underlying liver disease and gives recommendations for pulmonary screening in specific clinical scenarios in adults with chronic liver disease planned for LT. This document also aims to standardize the strategies for preoperative evaluation of these pulmonary issues in this subset of patients. Proposed recommendations were based on selected single case reports, small series, registries, databases, and expert opinion. The paucity of randomized, controlled trials in either of these disorders was noted. Additionally, this review will highlight the lacunae in our current evaluation strategy, challenges faced, and will provide direction to potentially useful futuristic preoperative evaluation strategies.
ABSTRACT
Background and Aims: Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) is an infectious disease. The use of video laryngoscopes is recommended for intubation of patients with COVID-19. But in resource-poor countries, it is rare to have video laryngoscopes available. In this trial, we have compared the ease of oral intubation by direct laryngoscopy with styletted endotracheal tube and intubation over the bougie, with the use of the aerosol box. The secondary objectives were comparison of the incidence of airway loss, attempts taken to intubate, time for intubation and hemodynamic changes. Material and Methods: 80 non-coronavirus infected patients coming for an elective procedure under general anesthesia were recruited in this randomized control trial. Participants were assigned into groups S and B using a computer-generated random sequence of numbers by closed envelope technique. In both groups, aerosol box was used. In Group S, participants were intubated by direct laryngoscopy with a styletted endotracheal tube and in group B, after direct laryngoscopy, the endotracheal tube was railroaded over the bougie. Results: Ease of endotracheal intubation was good (67.5%% vs. 45%), satisfactory (32.5%% vs. 37.5%), and poor (0% vs. 17.5%) in group S and B respectively (P < 0.011). The attempts required for intubation were similar in both groups. The time for intubation was significantly less in group S than B (23 vs. 55 s). Conclusion: The use of a styletted endotracheal tube made intubation easier and faster than tracheal intubation with bougie when the aerosol box was used in patients without known or predicted difficult airway and significant medical comorbidities.
ABSTRACT
Background: The occurrence of postoperative pulmonary complications (PPCs) and other sequelae of COVID-19 infections like thromboembolic events in patients coming for surgery following COVID-19 infection in the Indian population had not been adequately studied. Aim of the Study: We evaluated the incidence of PPCs, acute kidney injury, and thromboembolic complications such as pulmonary embolism, deep-vein thrombosis, myocardial infarction, stroke, and 30-day mortality rate in post-COVID-19 patients undergoing surgery compared to those without a history of COVID-19 infection. Settings and Design: It was a retrospective, observational, case–control study conducted in a tertiary care center. Materials and Methods: One hundred and sixty-six post-COVID-19 surgical patients were included. A matched control group (n = 166) was formed by choosing patients with no history of COVID-19 who underwent similar surgical procedures under a similar technique of anesthesia. Their medical records were analyzed for the development of postoperative pulmonary and nonpulmonary complications and 30-day mortality. Statistical Analysis Used: Independent samples t-test and Chi-squared test were used for statistical analysis. Results: The mean age of patients in the control group was significantly higher than those in the post-COVID-19 group. The number of patients who received two doses of vaccine was also significantly higher in the control group. Comparison of the distribution of preexisting medical conditions and postoperative complications, duration of hospital stay, and incidence of 30-day mortality did not show any significant difference in both groups. Conclusion: Incidence of postoperative complications, length of hospital stay, and 30-day mortality in post-COVID-19 patients undergoing surgical procedures were comparable with patients with no history of COVID-19 infection.
ABSTRACT
BACKGROUND: The safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines have not yet been reported. We therefore aimed to report the results of a substudy within a phase 3 UK trial, by evaluating the safety, immunogenicity, and efficacy of NVX-CoV2373 when co-administered with licensed seasonal influenza vaccines. METHODS: We did a planned exploratory substudy as part of the randomised, observer-blinded, placebo-controlled, phase 3 trial of the safety and efficacy of the COVID-19 vaccine (NVX-CoV2373) by co-administrating the influenza vaccine at four study hospitals in the UK. Approximately, the first 400 participants meeting the main study entry criteria-with no contraindications to influenza vaccination-were invited to join the substudy. Participants of the main study were randomly assigned (1:1) to receive two intramuscular injections of either NVX-CoV2373 (5 µg) or placebo (normal saline) 21 days apart; participants enrolled into the substudy were co-vaccinated with a single (0·5 mL) intramuscular, age-appropriate (quadrivalent influenza cell-based vaccine [Flucelvax Quadrivalent; Seqirus UK, Maidenhead] for those aged 18-64 years and adjuvanted trivalent influenza vaccine [Fluad; Seqirus UK, Maidenhead] for those ≥65 years), licensed, influenza vaccine on the opposite deltoid to that of the first study vaccine dose or placebo. The influenza vaccine was administered in an open-label manner and at the same time as the first study injection. Reactogenicity was evaluated via an electronic diary for 7 days after vaccination in addition to monitoring for unsolicited adverse events, medically attended adverse events, and serious adverse events. Immunogenicity was assessed with influenza haemagglutination inhibition and SARS-CoV-2 anti-spike protein IgG assays. Vaccine efficacy against PCR-confirmed, symptomatic COVID-19 was assessed in participants who were seronegative at baseline, received both doses of study vaccine or placebo, had no major protocol deviations affecting the primary endpoint, and had no confirmed cases of symptomatic COVID-19 from the first dose until 6 days after the second dose (per-protocol efficacy population). Immunogenicity was assessed in participants who received scheduled two doses of study vaccine, had a baseline sample and at least one post-vaccination sample, and had no major protocol violations before unmasking (per-protocol immunogenicity population). Reactogenicity was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo and had data collected for reactogenicity events. Safety was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo. Comparisons were made between participants of the substudy and the main study (who were not co-vaccinated for influenza). This study is registered with ClinicalTrials.gov, number NCT04583995. FINDINGS: Between Sept 28, 2020, and Nov 28, 2020, a total of 15 187 participants were randomised into the main phase 3 trial, of whom 15 139 received treatment (7569 received dose one of NVX-CoV2373 and 7570 received dose one of placebo). 431 participants were co-vaccinated with a seasonal influenza vaccine in the substudy (217 received NVX-CoV2373 plus the influenza vaccine and 214 received placebo plus the influenza vaccine). In general, the substudy participants were younger, more racially diverse, and had fewer comorbid conditions than those in the main study. Reactogenicity events were more common in the co-administration group than in the NVX-CoV2373 alone group: tenderness (113 [64·9%] of 174 vs 592 [53·3%] of 1111) or pain (69 [39·7%] vs 325 [29·3%]) at injection site, fatigue (48 [27·7%] vs 215 [19·4%]), and muscle pain (49 [28·3%] vs 237 [21·4%]). Incidences of unsolicited adverse events, treatment-related medically attended adverse events, and serious adverse events were low and balanced between the co-administration group and the NVX-CoV2373 alone group. No episodes of anaphylaxis or deaths were reported within the substudy. Co-administration resulted in no change to influenza vaccine immune response although a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. NVX-CoV2373 vaccine efficacy in the substudy (ie, participants aged 18 to <65 years) was 87·5% (95% CI -0·2 to 98·4) and in the main study was 89·8% (95% CI 79·7-95·5). INTERPRETATION: To our knowledge, this substudy is the first to show the safety, immunogenicity, and efficacy profile of a COVID-19 vaccine when co-administered with seasonal influenza vaccines. Our results suggest concomitant vaccination might be a viable immunisation strategy. FUNDING: Novavax.