1.Diagnostic accuracy of left ventricular outflow tract velocity time integral versus inferior vena cava collapsibility index in predicting post-induction hypotension during general anesthesia: an observational study
Vibhuti SHARMA ; Arti SHARMA ; Arvind SETHI ; Jyoti PATHANIA
Acute and Critical Care 2024;39(1):117-126
Point of care ultrasound (POCUS) is being explored for dynamic measurements like inferior vena cava collapsibility index (IVC-CI) and left ventricular outflow tract velocity time integral (LVOT-VTI) to guide anesthesiologists in predicting fluid responsiveness in the preoperative period and in treating post-induction hypotension (PIH) with varying accuracy. Methods: In this prospective, observational study on included 100 adult patients undergoing elective surgery under general anesthesia, the LVOT-VTI and IVC-CI measurements were performed in the preoperative room 15 minutes prior to surgery, and PIH was measured for 20 minutes in the post-induction period. Results: The incidence of PIH was 24%. The area under the curve, sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of the two techniques at 95% confidence interval was 0.613, 30.4%, 93.3%, 58.3%, 81.4%, 73.6% for IVC-CI and 0.853, 83.3%, 80.3%, 57.1%, 93.8%, 77.4% for LVOT-VTI, respectively. In multivariate analysis, the cutoff value for IVC-CI was >51.5 and for LVOT-VTI it was ≤17.45 for predicting PIH with odd ratio [OR] of 8.491 (P=0.025) for IVCCI and OR of 17.427 (P<0.001) for LVOT. LVOT-VTI assessment was possible in all the patients, while 10% of patients were having poor window for IVC measurements. Conclusions: We recommend the use of POCUS using LVOT-VTI or IVC-CI to predict PIH, to decrease the morbidity of patients undergoing surgery. Out of these, we recommend LVOT-VTI measurements as it has showed a better diagnostic accuracy (77.4%) with no failure rate.
2.Diagnostic accuracy of left ventricular outflow tract velocity time integral versus inferior vena cava collapsibility index in predicting post-induction hypotension during general anesthesia: an observational study
Vibhuti SHARMA ; Arti SHARMA ; Arvind SETHI ; Jyoti PATHANIA
Acute and Critical Care 2024;39(1):117-126
Point of care ultrasound (POCUS) is being explored for dynamic measurements like inferior vena cava collapsibility index (IVC-CI) and left ventricular outflow tract velocity time integral (LVOT-VTI) to guide anesthesiologists in predicting fluid responsiveness in the preoperative period and in treating post-induction hypotension (PIH) with varying accuracy. Methods: In this prospective, observational study on included 100 adult patients undergoing elective surgery under general anesthesia, the LVOT-VTI and IVC-CI measurements were performed in the preoperative room 15 minutes prior to surgery, and PIH was measured for 20 minutes in the post-induction period. Results: The incidence of PIH was 24%. The area under the curve, sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of the two techniques at 95% confidence interval was 0.613, 30.4%, 93.3%, 58.3%, 81.4%, 73.6% for IVC-CI and 0.853, 83.3%, 80.3%, 57.1%, 93.8%, 77.4% for LVOT-VTI, respectively. In multivariate analysis, the cutoff value for IVC-CI was >51.5 and for LVOT-VTI it was ≤17.45 for predicting PIH with odd ratio [OR] of 8.491 (P=0.025) for IVCCI and OR of 17.427 (P<0.001) for LVOT. LVOT-VTI assessment was possible in all the patients, while 10% of patients were having poor window for IVC measurements. Conclusions: We recommend the use of POCUS using LVOT-VTI or IVC-CI to predict PIH, to decrease the morbidity of patients undergoing surgery. Out of these, we recommend LVOT-VTI measurements as it has showed a better diagnostic accuracy (77.4%) with no failure rate.
3.Diagnostic accuracy of left ventricular outflow tract velocity time integral versus inferior vena cava collapsibility index in predicting post-induction hypotension during general anesthesia: an observational study
Vibhuti SHARMA ; Arti SHARMA ; Arvind SETHI ; Jyoti PATHANIA
Acute and Critical Care 2024;39(1):117-126
Point of care ultrasound (POCUS) is being explored for dynamic measurements like inferior vena cava collapsibility index (IVC-CI) and left ventricular outflow tract velocity time integral (LVOT-VTI) to guide anesthesiologists in predicting fluid responsiveness in the preoperative period and in treating post-induction hypotension (PIH) with varying accuracy. Methods: In this prospective, observational study on included 100 adult patients undergoing elective surgery under general anesthesia, the LVOT-VTI and IVC-CI measurements were performed in the preoperative room 15 minutes prior to surgery, and PIH was measured for 20 minutes in the post-induction period. Results: The incidence of PIH was 24%. The area under the curve, sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of the two techniques at 95% confidence interval was 0.613, 30.4%, 93.3%, 58.3%, 81.4%, 73.6% for IVC-CI and 0.853, 83.3%, 80.3%, 57.1%, 93.8%, 77.4% for LVOT-VTI, respectively. In multivariate analysis, the cutoff value for IVC-CI was >51.5 and for LVOT-VTI it was ≤17.45 for predicting PIH with odd ratio [OR] of 8.491 (P=0.025) for IVCCI and OR of 17.427 (P<0.001) for LVOT. LVOT-VTI assessment was possible in all the patients, while 10% of patients were having poor window for IVC measurements. Conclusions: We recommend the use of POCUS using LVOT-VTI or IVC-CI to predict PIH, to decrease the morbidity of patients undergoing surgery. Out of these, we recommend LVOT-VTI measurements as it has showed a better diagnostic accuracy (77.4%) with no failure rate.
4.Diagnostic accuracy of left ventricular outflow tract velocity time integral versus inferior vena cava collapsibility index in predicting post-induction hypotension during general anesthesia: an observational study
Vibhuti SHARMA ; Arti SHARMA ; Arvind SETHI ; Jyoti PATHANIA
Acute and Critical Care 2024;39(1):117-126
Point of care ultrasound (POCUS) is being explored for dynamic measurements like inferior vena cava collapsibility index (IVC-CI) and left ventricular outflow tract velocity time integral (LVOT-VTI) to guide anesthesiologists in predicting fluid responsiveness in the preoperative period and in treating post-induction hypotension (PIH) with varying accuracy. Methods: In this prospective, observational study on included 100 adult patients undergoing elective surgery under general anesthesia, the LVOT-VTI and IVC-CI measurements were performed in the preoperative room 15 minutes prior to surgery, and PIH was measured for 20 minutes in the post-induction period. Results: The incidence of PIH was 24%. The area under the curve, sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of the two techniques at 95% confidence interval was 0.613, 30.4%, 93.3%, 58.3%, 81.4%, 73.6% for IVC-CI and 0.853, 83.3%, 80.3%, 57.1%, 93.8%, 77.4% for LVOT-VTI, respectively. In multivariate analysis, the cutoff value for IVC-CI was >51.5 and for LVOT-VTI it was ≤17.45 for predicting PIH with odd ratio [OR] of 8.491 (P=0.025) for IVCCI and OR of 17.427 (P<0.001) for LVOT. LVOT-VTI assessment was possible in all the patients, while 10% of patients were having poor window for IVC measurements. Conclusions: We recommend the use of POCUS using LVOT-VTI or IVC-CI to predict PIH, to decrease the morbidity of patients undergoing surgery. Out of these, we recommend LVOT-VTI measurements as it has showed a better diagnostic accuracy (77.4%) with no failure rate.
5.Vaccines development in India: advances, regulation, and challenges
Rakshita SALALLI ; Jyoti Ram DANGE ; Sonia DHIMAN ; Teenu SHARMA
Clinical and Experimental Vaccine Research 2023;12(3):193-208
One of the most significant medical advancements in human history is the development of vaccines. Progress in vaccine development has always been greatly influenced by scientific human innovation. The main objective of vaccine development would be to acquire sufficient evidence of vaccine effectiveness, immunogenicity, safety, and/or quality to support requests for marketing approval. Vaccines are biological products that enhance the body’s defenses against infectious diseases. From the first smallpox vaccine to the latest notable coronavirus disease 2019 nasal vaccine, India has come a long way. The development of numerous vaccines, driven by scientific innovation and advancement, combined with researcher’s knowledge, has helped to reduce the global burden of disease and mortality rates. The Drugs and Cosmetics Rules of 1945 and the New Drugs and Clinical Trials Rules of 2019 specify the requirements and guidelines for CMC (chemistry, manufacturing, and controls) for all manufactured and imported vaccines, including those against coronavirus infections. This article provides an overview of the regulation pertaining to the development process, registration, and approval procedures for vaccines, particularly in India, along with their brief history.