Takeaways from the Recarbrio Conundrum: Has the FDA Jumped the Gun?

Recarbrio is a novel antibiotic approved by US-FDA. It was initially found to be useful in treating various resistant gram negative infections. A recent investigation revealed lack of methodological and scientific integrity behind the process of FDA approval for this drug. This incident is a lesson for us that we shall not consider FDA clearance as the gold standard before approving any drug in the Indian market or start using it before having adequate data from our own clinical settings.

Commentary on "Prediction of Successful Spontaneous Breathing Trial and Extubation of Trachea by Lung Ultrasound in Mechanically Ventilated Patients in Intensive Care Unit".

How to cite this article: Chowdhury SR, Kundu R. Commentary on "Prediction of Successful Spontaneous Breathing Trial and Extubation of Trachea by Lung Ultrasound in Mechanically Ventilated Patients in Intensive Care Unit." Indian J Crit Care Med 2023;27(8):596.

Meta-analysis comparing diabetes in pregnancy study group India (DIPSI) vs the international association of the diabetes and pregnancy study groups (IADPSG) criteria for diagnosis of gestational diabetes among Indian population.

Despite consensus on universal screening of women at 24-28 weeks for a diagnosis of gestational diabetes, controversy remains on an appropriate criterion. The study is aimed to find out the sensitivity and specificity of Diabetes in Pregnancy Study Group India (DIPSI) criteria compared to the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria for diagnosis of Gestational Diabetes Mellitus (GDM). A meta-analysis of studies comparing DIPSI as an index test to IADPSG as the reference test for diagnosing GDM was carried out. A total of 8 comparative studies were included. Pooled analysis showed a sensitivity of 0.44 [0.29 to 0.60] and specificity of 0.97 [0.94 to 0.98], which means the index test DIPSI will correctly identify only 44% of the subjects who have the disease (GDM positive) but it will also fail to identify 56% of the GDM positive subjects. Derek's funnel graph revealed fewerchances of publication bias. Though convenient, DIPSI criteria was not found to be sensitive enough for a diagnosis of GDM and missed an opportunity to improve pregnancy and subsequent long-term outcomes for a substantial number of women. Further studies should focus on comparing pregnancy outcomes for the two criteria, so that decision to adopt any criteria is more evidence-based.

Nebulised magnesium sulphate as an adjuvant to the treatment of acute exacerbation of COPD: A systematic review and meta-analysis of randomised controlled trials with trial sequential analysis.

The purpose of this meta-analysis was to evaluate the efficacy of nebulised magnesium in the treatment of acute exacerbation of COPD. PubMed and Embase databases were searched for randomised controlled trials comparing any dose of nebulised magnesium sulphate with placebo for treatment of acute exacerbation of COPD, published from database inception till 30 June 2022. Bibliographic mining of relevant results was performed to identify any additional studies. Data extraction and analyses were done independently by review authors and any disagreements were resolved through consensus. Meta-analysis was done using a fixed-effect model at clinically significant congruent time points reported across maximum studies to ensure comparability of treatment effect. Four studies met the inclusion criteria, randomly assigning 433 patients to the comparisons of interest in this review. Pooled analysis showed that nebulised magnesium sulphate improved pulmonary expiratory flow function at 60 minutes after initiation of intervention compared to placebo [median difference (MD) 9.17%, 95% confidence interval (CI) 2.94 to 15.41]. Analysis of expiratory function in terms of standardised mean differences (SMD) revealed a small yet significant positive effect size (SMD 0.24, 95% CI 0.04 to 0.43). Among the secondary outcomes, nebulised magnesium sulphate reduced the need for ICU admission (risk ratio 0.52, 95% CI 0.28 to 0.95), amounting to 61 fewer ICU admissions per 1000 patients. No difference was noted in the need for hospital admission, need for ventilatory support, or mortality. No adverse events were reported. Nebulised magnesium sulphate improves pulmonary expiratory flow function and reduces the need for ICU admission in patients with acute exacerbation of COPD.

The use of preoperative inferior vena cava ultrasound to predict anaesthesia-induced hypotension: a systematic review.

Preoperative ultrasound assessment of inferior vena cava (IVC) diameter and the collapsi-bility index might identify patients with intravascular volume depletion. The purpose of this review was to gather the existing evidence to find out whether preoperative IVC ultrasound (IVCUS) derived parameters can reliably predict hypotension after spinal or general anaesthesia. PubMed was searched to identify research articles that addressed the role of IVC ultrasound in predicting hypotension after spinal and general anaesthesia in adult patients. We included 4 randomized control trials and 17 observational studies in our final review. Among these, 15 studies involved spinal anaesthesia and 6 studies involved general anaesthesia. Heterogeneity with respect to the patient populations under evaluation, definitions used for hypotension after anaesthesia, IVCUS assessment methods, and cut-off values for IVCUS-derived parameters to predict hypotension precluded pooled meta-analysis. The maximum and minimum reported sensitivity of the IVC collapsibility index (IVCCI) for predicting post-spinal hypotension was 84.6% and 58.8% respectively, while the maximum and minimum specificities were 93.1% and 23.5% respectively. For the prediction of hypotension after general anaesthesia induction, the reported ranges of sensitivity and specificity of IVCCI were 86.67% to 45.5% and 94.29% to 77.27%, respectively. Current literature on the predictive role of IVCUS for hypotension after anaesthesia is heterogeneous both in methodology and in results. Standardization of the definition of hypotension under anaesthesia, method of IVCUS assessment, and the cut-offs for IVC diameter and the collapsibility index for prediction of hypotension after anaesthesia are necessary for drawing clinically relevant conclusions.

Diabetes in Pregnancy Study Group India (DIPSI) and WHO (1999) diagnostic criteria for GDM: A meta-analysis.

BACKGROUND AND AIMS: The diagnosis of Gestational diabetes mellitus (GDM) is challenging and controversial due to the heterogeneity or lack of consensus regarding the screening and diagnostic criteria for GDM. METHODS: A meta-analysis of studies comparing Diabetes in Pregnancy Study Group India (DIPSI) and WHO 1999 for diagnosing GDM was carried out. RESULTS: A total of 6 comparative studies were included. Pooled analysis showed sensitivity and specificity as 0.79 (95% CI: 0.53 to 0.92) and 0.97 (95% CI: 0.94 to 0.98) respectively. CONCLUSION: Based on the results of the meta-analysis, DIPSI showed higher specificity when compared to WHO 1999, hence may be used to rule in disease in probable GDM cases. However, the results should be interpreted more cautiously and carefully since only a few studies were included.

The Impact of High-flow Nasal Cannula vs Other Oxygen Delivery Devices during Bronchoscopy under Sedation: A Systematic Review and Meta-analyses.

Background: The widespread diagnostic and therapeutic application of bronchoscopy is often associated with complications like desaturation. This systematic review and meta-analysis intend to scrutinize whether the high-flow nasal cannula (HFNC) is advantageous for providing respiratory support during bronchoscopic procedures under sedation, in comparison with other conventional modalities for oxygen therapy. Materials and methods: A thorough screening of electronic databases was done till 31st December 2021 after obtaining registration in PROSPERO (CRD42021245420). Randomized controlled trials (RCT), evaluating the impact of HFNC and standard/any other oxygen-delivery devices during bronchoscopy were included in this meta-analysis. Results: We retrieved in nine RCTs, with a total of 1306 patients, the application of HFNC during bronchoscopy led to decreased number of desaturation spells [relative risk (RR) 0.34, 95% confidence interval (CI) 0.27-0.44, I 2 = 23%], higher nadir value of SpO2 [Mean difference (MD) 4.30, 95% CI 2.41-6.19, I 2 = 96%], and improved PaO2 from baseline (MD 21.77, 95% CI 2.8-40.74, I 2 = 99%), along with similar PaCO2 values (MD -0.34, 95% CI -1.82 to 1.13, I 2 = 58%) just after the procedure. However, apart from desaturation spell, the findings are significantly heterogeneous. In subgroup analysis, HFNC had significantly lesser desaturation spells and better oxygenation than low-flow devices, but in comparison to noninvasive ventilation (NIV) had a lower nadir value of SpO2 with no other significant difference. Conclusion: High-flow nasal cannula led to greater oxygenation and prevented desaturation spells more effectively in comparison with low-flow devices like nasal cannula, venturi mask, etc., and may be considered as an alternative to NIV during bronchoscopy in certain high-risk patients. How to cite this article: Roy A, Khanna P, Chowdhury SR, Haritha D, Sarkar S. The Impact of High-flow Nasal Cannula vs Other Oxygen Delivery Devices during Bronchoscopy under Sedation: A Systematic Review and Meta-analyses. Indian J Crit Care Med 2022;26(10):1131-1140.

Comparison of ultrasound-guided versus conventional palpatory method of dorsalis pedis artery cannulation: A randomized controlled trial.

BACKGROUND: Whether use of ultrasound (USG) to cannulate dorsalis pedis artery (DPA) increases first pass successful cannulation, decreases the number of attempts and complications as compared to palpation technique was assessed in this study. DESIGN: Randomized controlled trial. SETTING: Operating room. PATIENTS: About 60 adult patients undergoing any head-neck or faciomaxillary surgery requiring arterial cannulation were enrolled. INTERVENTION: DPA was cannulated either by USG-guided technique (USG group) or by palpation technique (palpation group) with 30 patients in each group. MEASUREMENT: Data were assessed for "first-attempt success" of cannulation, number of attempts, assessment time, cannulation time, cannulation failure, and incidence of complications. MAIN RESULTS: Successful first pass DPA cannulation was similar between the groups (ultrasound group vs. palpation group, 76.7% vs. 60%, respectively) [relative risk (95% confidence interval (CI) = 0.69 (0.43, 1.13), P = 0.267)] as was the number of attempts required for successful cannulation [median (interquartile range (IQR) number of attempts 1 (1-2) in palpation group P and USG group U 1 (1-1); P = 0.376]. Median (IQR) assessment time was significantly less (P < 0.0004) in palpation group [palpation group 12 (9-17) vs. USG group U 19 (15-21)]. However, cannulation time was significantly higher (P = 0.0093) in Group P [median (IQR) 17.5 (12-36 s) and 11.5 (9-15)]. Although the total procedure time (sum of both assessment time and cannulation time) remain statistically similar between two groups (P = 0.8882). CONCLUSIONS: Use of USG for the cannulation of DPA is feasible, but it is not associated with significant increase in first-attempt success rate, decrease in total number of cannulation attempts or total procedure time.

Role of IVC collapsibility index to predict post spinal hypotension in pregnant women undergoing caesarean section. An observational trial.

BACKGROUND: Postspinal anesthesia hypotension (PSH) in pregnant women is common and may lead to poor maternal and fetal outcome. Fluid loading in pregnant women before spinal anesthesia to prevent hypotension is of limited ability. We hypothesized that those women who are hypovolemic before spinal anesthesia may be at risk of PSH and inferior vena cava collapsibility index (IVCCI) will be able to identify hypovolemic parturients. METHODS: In this prospective observational study, n = 45 women undergoing elective lower segment cesarean section with singleton pregnancy were recruited and IVCCI in left lateral tilt (with wedge) and supine position (without wedge) were noted by M-mode ultrasound (USG) before spinal anesthesia. After spinal anesthesia, changes in blood pressure were noted till 15 min after spinal anesthesia. RESULTS: USG measurements were obtained in 40 patients and 23 of 40 patients (57.5%) had at least one episode of hypotension. Area under the ROC curve of IVCCI with wedge to predict PSH was 0.46 (95% CI 0.27, 0.64) and best cut-of value was 25.64 with a sensitivity and specificity of 60.9% and 35.5%, respectively. Area under the ROC curve of IVCCI without wedge to predict PSH was 0.38 (95% CI 0.19, 0.56) and best cut-of value was 20.4 with a sensitivity and specificity of 69.6% and 23.5%, respectively. CONCLUSION: We conclude that IVCCI is not a predictor of PSH in pregnant women undergoing elective cesarean section.