Introduction Chronic metabolic disorders such as diabetes mellitus (DM) are becoming a global health concern. According to recent studies, the pathophysiology of DM may involve factors other than traditional glycemic control, such as electrolyte balance and thiamin status. Therefore, this study evaluated the relationship between sodium and potassium and serum thiamin levels in patients with type 1 and type 2 DM. Methods This study was conducted in multiple diabetic outpatient clinics and centers in Karachi, Pakistan, using a non-probability convenience sampling method. The study lasted for approximately six months after the synopsis was approved. A total of 64 patients were selected, 32 of whom each had type 1 and type 2 DM. All patients who were between the ages of 25 and 46 years old and had either type 1 or type 2 DM were included in the study. A Mann-Whitney test and an independent t-test were used to compare the means between the two study groups. Pearson's correlation and chi-square tests were used to determine the variables, correlations, and associations with type 1 and type 2 DM. Results The study findings showed that the distribution of gender among diabetic patients revealed that among males, eight (25.0%) had type 1 DM, and 10 (31.2%) had type 2 DM. Among females, 24 (75.0%) had type 1 DM, and 22 (68.8%) had type 2 DM. Significant correlations were observed in the means of blood glucose levels, such as glycated hemoglobin (HbA1c), fasting blood sugar (FBS), and serum thiamin levels, among patients with type 1 and type 2 DM (p < 0.001). The HbA1c, FBS, and serum thiamin levels were significantly higher in type 2 DM patients than in type 1 DM patients. Among patients with type 1 DM, sodium levels were not substantially correlated with thiamin levels (p = 0.570, r = 0.104), whereas potassium levels were significantly correlated with thiamin levels (p = 0.005, r = 0.263). Conclusion We conclude that the sodium level was not significantly correlated with serum thiamin status in type 1 and type 2 DM, whereas a low positive correlation was observed between potassium and serum thiamin levels in type 1 DM. However, there was no significant correlation concerning potassium levels in type 2 DM.
Background Primary hypothyroidism is a common endocrine disorder resulting from inadequate production of thyroid hormones. Anemia is a common condition that can occur in hypothyroidism. Anemia may occur due to nutrient deficiency, such as iron or vitamin B12 deficiency due to chronic disease in hypothyroidism. Therefore, it is important to evaluate the cause of anemia in hypothyroidism. Objective The aim of this study was to determine the frequency of anemia and its types in patients with primary hypothyroidism. Methods This was a prospective cross-sectional observational study conducted at the Department of Medicine, Jinnah Postgraduate Medical Center, Karachi, Pakistan, using non-probability consecutive sampling. A total of 176 adults aged 18-65 years of either gender, newly diagnosed with primary hypothyroidism, or with any of its symptoms were included in the study. Patients already on anti-thyroid medication and with post-thyroidectomy hypothyroidism were excluded from the study. The duration of the study was 1.5 years, from January 2020 to July 2021. After ethical approval, written informed consent was obtained from each patient. Demographical data along with results of complete blood picture, including Hb and MCV for diagnosing anemia and its types were recorded on a pre-designed proforma. The chi-square test was applied keeping p < 0.05 as statistically significant. Results The mean age of the patients was 42.19 ± 8.43 years, with 59.66% (n = 105) females and 40.34% (n = 71) males. A total of 67% (n =118) patients were found to be anemic. Of these, 38.64% (n = 68) patients had normocytic anemia, 19.32% (n = 34) microcytic anemia, and 9.25% (n = 16) patients had macrocytic anemia; 56.34% (n = 40) males and 74.29% (n = 78) females were reported to be anemic (p = 0.01). Conclusion In our study, the frequency of anemia in patients with hypothyroidism was high, with normocytic anemia being the most common type. It is important to know the type of anemia in hypothyroidism, as normocytic anemia is due to the chronic disease process (anemia of chronic disease) and may not respond to nutrient supplementation. Conversely, microcytic anemia is commonly due to iron deficiency and macrocytic anemia is due to vitamin B12 deficiency and therefore, they require replacement therapy. In any case, it is important to identify and treat the underlying cause of anemia.
Introduction Serum urea and creatinine levels are the most commonly recognized parameters for evaluating renal impairment in patients with diabetes mellitus (DM). Therefore, this study evaluated the correlation between urea and creatinine levels and thiamin levels in patients with type 1 DM (T1DM) and type 2 DM (T2DM). Methods This multi-center, cross-sectional study was conducted at diabetic outpatient clinics in Karachi. The duration of the study was six months, from 1st January 2023 to 30th June 2023. A total of 60 patients were enrolled and divided into two groups, i.e., T1DM and T2DM, each containing 30 patients of both genders between the ages of 24 and 42 years. Demographic data and biochemical variables, such as urea, creatinine, random blood sugar, fasting blood sugar, hemoglobin A1c, and serum thiamin levels, were assessed. The Mann-Whitney U test and independent t-test were used to associate the means between the two study groups. The chi-square test and Spearman's correlation coefficient were used to determine the associations between the variables and T1DM and T2DM. Results The study results revealed that patients with T2DM had a significantly higher frequency of hypertension (p = 0.039), neuropathy (p = 0.038), and coronary artery disease (p = 0.010) than those with T1DM, in both genders. The level of serum thiamin was found to be significantly higher (p < 0.001) in T2DM (14.8 ± 4.82) than in T1DM patients (7.34 ± 1.90). Similarly, serum creatinine was higher in T2DM than in T1DM patients (0.83 ± 0.12 vs. 0.76 ± 0.17, p = 0.025). Moreover, the correlation of urea and creatinine with thiamin levels in T1DM and T2DM patients revealed that in T1DM and T2DM patients, urea and creatinine showed an insignificant positive correlation with thiamin levels. Conclusion We found a significantly higher level of serum creatinine and thiamin levels in T2DM patients than in T1DM; however, there was no significant correlation between urea and creatinine levels and thiamin status in T1DM and T2DM patients. Therefore, we conclude that although serum urea, creatinine, and serum thiamin are important disease biomarkers in diabetic patients, there is no correlation between them.
Introduction The coronavirus disease 2019 (COVID-19) pandemic led to the more common use of venovenous (VV) extracorporeal membrane oxygenation (ECMO) for adults with acute respiratory distress syndrome (ARDS). While tracheostomy is generally understood to decrease the risks of prolonged endotracheal intubation, there is conflicting data regarding the benefit of tracheostomy in patients on ECMO. The purpose of this study is to determine whether ECMO cannulation before tracheostomy impacted patient outcomes. Methods This is a retrospective chart review of patients who underwent tracheostomy for COVID-19-related ARDS at a tertiary academic center from March 2020 through March 2022. Patients were separated into two groups based on whether they were cannulated for ECMO prior to tracheostomy. Fisher's exact test or Wilcoxon rank sum test was used to compare the two groups. Results A total of 24 patients were included in the study, with 13 in the ECMO group and 11 in the non-ECMO group. There was no significant difference in age, comorbidities, race, or gender between the groups. Patients on ECMO had a longer time from admission to intubation (seven days vs. three days, p=.002), were more likely to have multiple intubations (54% vs 9%, p= .033), had increased rates of postoperative bleeding (62% vs. 18%, p = .047), and had a higher mortality rate (39% vs. 0%, p= .041). Conclusions ECMO cannulation prior to tracheostomy for COVID-19-related ARDS is associated with poorer outcomes. It is unclear whether this is related to a more severe disease burden in these patients. Further study is needed to evaluate this and guide future management.
Objectives: Posterior nasal nerve (PNN) ablation is a minimally invasive treatment option for patients with chronic rhinitis. Recent evidence shows that parasympathetic innervation of the nasal cavity is more extensive and there are many fibers posterior to the lateral attachment of the middle turbinate. We describe a modified ablative technique that targets the extensive innervation of the posterior nasal nerves. Methods: Description of the technique and retrospective cohort analysis. In addition to the traditional radiofrequency and cryoablation targets, three additional treatment sites posterior to the middle turbinate were targeted using radiofrequency ablation, as well as one focused treatment posteroinferior to the middle turbinate attachment using cryotherapy ablation. The primary outcome collected was a 30% improvement in overall rhinitis symptoms. Results: Forty-five patients received treatment and completed 3-month follow-up using the modified technique for radiofrequency and cryotherapy PNN ablation. Previously, our institution documented a 64.5% responder rate at 3 months. After introducing the modified technique, the response rate at 3 months significantly improved (64.5% vs. 91.1%, p = .004). Conclusions: This report suggests improved efficacy with implementation of the modified technique for in-office PNN ablation. Given the extensive nature of the post-ganglionic parasympathetic fibers of the nasal cavity which often emerge posterior to the middle turbinate attachment, a modified technique to target these branches should be considered. Prospective randomized studies comparing this modified technique to the traditional technique are needed. Level of Evidence: III.
Transgender individuals face significant health disparities including deficiencies in physician education, knowledge, and comfort with care. The objective of this study was to determine the perceptions, practice patterns, and familiarity of facial plastic surgeons with transgender health care. An anonymous questionnaire was sent to facial plastic surgeons within the American Academy of Facial Plastic and Reconstructive Surgery list-serve. Primary datapoints included participant characteristics, transgender-related experience, and educational goals. Of the 66 facial plastic surgeons surveyed, 49% had treated 1 to 10 transgender patients during their career, and 70% were actively treating at least 1 transgender patient. The number of patients treated and surgeries performed was significantly associated with self-perceived competence, comfort counseling on gender-affirming surgeries, discussing gender identity, asking preferred pronouns, and a desire to learn more about transgender care. Most participants (61%) obtained transgender care training through real-world experience, with only 18% receiving formal training in residency or fellowship. In total, 50% of respondents believe transgender care training among facial plastic surgeons is inadequate and 60% support its incorporation into residency/fellowship curricula. Increased awareness is needed to address the disparities experienced by transgender patients. Many facial plastic surgeons desire to learn more and support incorporating transgender care into training. Understanding the current state of transgender care can assist the facial plastic community in promoting education that strengthens physicians' ability to deliver competent care that addresses the inequities faced by this diverse group.
OBJECTIVES: Transgender individuals face significant health disparities including deficiencies in physician education, knowledge, and comfort with transgender health care. As the prevalence of the transgender population increases more individuals may seek gender-affirming surgery. Herein, we present a survey study which presents data on (1) the current practice patterns, (2) the familiarity with, (3) the perception of, and (4) the future educational goals of transgender health care among laryngologists in the United States. METHODS: A cross-sectional survey study of practicing laryngologists in the United States. RESULTS: A total of 53 laryngologists participated in the study, with 50 (94.3%) coming from an academic practice. Survey response rate was 32.3% (54/167). The number of patients cared for and surgeries performed were significantly associated with self-perceived overall competence (p < 0.001 and p < 0.001), surgical competence (p = 0.013 and p < 0.001), and comfort counseling patients on gender-affirming surgeries (p < 0.001 and p < 0.001). Most obtained training through real-world experience (n = 46, 86.8%), whereas only 11 (20.7%) had formal training in residency or fellowship. Although 37 (70%) of participants felt competent caring for transgender patients, 38 (72%) want to learn more about transgender care, and 49 (93%) support incorporating transgender care into otolaryngology residency/fellowship curricula. CONCLUSION: There is a need for an increased awareness of transgender healthcare issues to address disparities experienced by this diverse population. Many laryngologists report wanting to learn more about this developing part of our field and support incorporating transgender care into training. We attempt to spotlight the degree by which practicing laryngologists are familiar, competent, and comfortable with transgender care. LEVEL OF EVIDENCE: 5 Laryngoscope, 2024.
PURPOSE: Inherited deficiencies of CD40 and CD40 ligand (CD40L) reflect the crucial immunological functions of CD40-CD40L interaction/signaling. Although numerous studies have provided a detailed description of CD40L deficiency, reports of CD40 deficiency are scarce. Herein, we describe the characteristics of all reported patients with CD40 deficiency. METHODS: The PubMed, Embase and Web of Science databases were searched for relevant literature published till 7th August 2023. Study deduplication and identification of relevant reports was performed using the online PICO Portal. The data were extracted using a pre-designed data extraction form and the SPSS software was used for analysis. RESULTS: Systematic literature review revealed 40 unique patients with CD40 deficiency. Respiratory tract and gastrointestinal infections were the predominant clinical manifestations (observed in 93% and 57% patients, respectively). Sclerosing cholangitis has been reported in nearly one-third of patients. Cryptosporidium sp. (29%) and Pneumocystis jirovecii (21%) were the most common microbes identified. Very low to undetectable IgG levels and severely reduced/absent switch memory B cells were observed in all patients tested/reported. Elevated IgM levels were observed in 69% patients. Overall, splice-site and missense variants were the most common (36% and 32%, respectively) molecular defects identified. All patients were managed with immunoglobulin replacement therapy and antimicrobial prophylaxis was utilized in a subset. Hematopoietic stem cell transplantation (HSCT) has been performed in 45% patients (curative outcome observed in 73% of these patients). Overall, a fatal outcome was reported in 21% patients. CONCLUSIONS: We provide a comprehensive description of all important aspects of CD40 deficiency. HSCT is a promising curative treatment option for CD40 deficiency.
Cryptosporidiosis , Cryptosporidium , Hyper-IgM Immunodeficiency Syndrome , Immunologic Deficiency Syndromes , Lymphopenia , Humans , CD40 Ligand/genetics , Hyper-IgM Immunodeficiency Syndrome/genetics , Immunologic Deficiency Syndromes/genetics , CD40 Antigens/genetics , Immunoglobulin M
KEY POINTS: Hispanic-American patients with chronic rhinosinusitis with nasal polyps have a comparable level of tissue eosinophilia compared to their Caucasian counterparts in the United States. Mixed inflammation involving both neutrophils and eosinophils is more common in this population compared to Caucasians. Findings from this study may indicate that Hispanic-American patients have a unique endotype or endotypes that deserves further investigation.
Wireless communication has become an integral part of modern vehicles. However, securing the information exchanged between interconnected terminals poses a significant challenge. Effective security solutions should be computationally inexpensive, ultra-reliable, and capable of operating in any wireless propagation environment. Physical layer secret key generation has emerged as a promising technique, which leverages the inherent randomness of wireless-channel responses in amplitude and phase to generate high-entropy symmetric shared keys. The sensitivity of the channel-phase responses to the distance between network terminals makes this technique a viable solution for secure vehicular communication, given the dynamic behavior of these terminals. However, the practical implementation of this technique in vehicular communication is hindered by fluctuations in the communication link between line-of-sight (LoS) and non-line-of-sight (NLoS) conditions. This study introduces a key-generation approach that uses a reconfigurable intelligent surface (RIS) to secure message exchange in vehicular communication. The RIS improves the performance of key extraction in scenarios with low signal-to-noise ratios (SNRs) and NLoS conditions. Additionally, it enhances the network's security against denial-of-service (DoS) attacks. In this context, we propose an efficient RIS configuration optimization technique that reinforces the signals received from legitimate users and weakens the signals from potential adversaries. The effectiveness of the proposed scheme is evaluated through practical implementation using a 1-bit RIS with 64×64 elements and software-defined radios operating within the 5G frequency band. The results demonstrate improved key-extraction performance and increased resistance to DoS attacks. The hardware implementation of the proposed approach further validated its effectiveness in enhancing key-extraction performance in terms of the key generation and mismatch rates, while reducing the effect of the DoS attacks on the network.
Agro-industrial wastes and by-products are the natural and abundant resources of biomaterials to obtain various value-added items such as biopolymer films, bio-composites and enzymes. This study presents a way to fractionate and to convert an agro-industrial residue, sugarcane bagasse (SB), into useful materials with potential applications. Initially cellulose was extracted from SB which was then converted into methylcellulose. The synthesized methylcellulose was characterized by scanning electron microscopy and FTIR. Biopolymer film was prepared by using methylcellulose, polyvinyl alcohol (PVA), glutaraldehyde, starch and glycerol. The biopolymer was characterized to exhibit 16.30 MPa tensile strength, 0.05 g/m2 h of water vapor transmission rate, 366 % of water absorption to its original weight after 115 min of immersion, 59.08 % water solubility, 99.05 % moisture retention capability and 6.01 % of moisture absorption after 144 h. Furthermore, in vitro studies on absorption and dissolution of model drug by biopolymer showed 2.04 and 104.59 % of swelling ratio and equilibrium water content, respectively. Biocompatibility of the biopolymer was checked by using gelatin media and it was observed that swelling ratio was higher in initial 20 min of contact. The extracted hemicellulose and pectin from SB were fermented by a thermophilic bacterial strain, Neobacillus sedimentimangrovi UE25 that yielded 12.52 and 6.4 IU mL-1 of xylanase and pectinase, respectively. These industrially important enzymes further augmented the utility of SB in this study. Therefore, this study emphasizes the possibility for industrial application of SB to form various products.
Cellulose , Saccharum , Cellulose/chemistry , Methylcellulose , Polyvinyl Alcohol/chemistry , Saccharum/chemistry
This article reports the synthesis, characterization, geometrical optimization, and biological studies of new MBH-based organometallic compounds of medicinal significance. The ligand (MNHA) was prepared via the Morita-Baylis-Hillman (MBH) synthetic route, from aromatic aldehyde containing multiple functional groups. Metal complexes were prepared in an alkaline medium and under other suitable reaction conditions. Spectral and elemental analyses were used to identify the structural and molecular formulas of each compound. Optimized geometry was determined through density functional theory (DFT) B3LYP and 6-311++ G (d,p) basis set for the MBH adduct, whereas structures of novel complexes were optimized with the semi-empirical PM6 method. Powder XRD analysis furnished the crystal class of complexes, with Co3+, Cr3+, and Mn2+ being cubic, while Ni2+ was hexagonal, and Cu2+ was orthorhombic. Moreover, the ligand, along with Ni2+ and Co3+ complexes, showed profound antibacterial action against S. aureus, E. coli, B. pumilis, and S. typhi. Additionally, all of the complexes were shown to persist in the positive antioxidant potential of the ligand. Contrarily, not a single metal complex conserved the antifungal potentials of the ligand.
Coordination Complexes , Staphylococcus aureus , Ligands , Molecular Docking Simulation , Microbial Sensitivity Tests , Escherichia coli , Coordination Complexes/chemistry , Schiff Bases/chemistry
PURPOSE: Neurocritical care patients receive prolonged invasive mechanical ventilation (IMV), but there is poor specific information in this high-risk population about the liberation strategies of invasive mechanical ventilation. METHODS: ENIO (NCT03400904) is an international, prospective observational study, in 73 intensive care units (ICUs) in 18 countries from 2018 to 2020. Neurocritical care patients with a Glasgow Coma Score (GCS) ≤ 12, receiving IMV ≥ 24 h, undergoing extubation attempt or tracheostomy were included. The primary endpoint was extubation failure by day 5. An extubation success prediction score was created, with 2/3 of patients randomly allocated to the training cohort and 1/3 to the validation cohort. Secondary endpoints were the duration of IMV and in-ICU mortality. RESULTS: 1512 patients were included. Among the 1193 (78.9%) patients who underwent an extubation attempt, 231 (19.4%) failures were recorded. The score for successful extubation prediction retained 20 variables as independent predictors. The area under the curve (AUC) in the training cohort was 0.79 95% confidence interval (CI95) [0.71-0.87] and 0.71 CI95 [0.61-0.81] in the validation cohort. Patients with extubation failure displayed a longer IMV duration (14 [7-21] vs 6 [3-11] days) and a higher in-ICU mortality rate (8.7% vs 2.4%). Three hundred and nineteen (21.1%) patients underwent tracheostomy without extubation attempt. Patients with direct tracheostomy displayed a longer duration of IMV and higher in-ICU mortality than patients with an extubation attempt (success and failure). CONCLUSIONS: In neurocritical care patients, extubation failure is high and is associated with unfavourable outcomes. A score could predict extubation success in multiple settings. However, it will be mandatory to validate our findings in another prospective independent cohort.
Airway Extubation , Respiration, Artificial , Humans , Prospective Studies , Tracheostomy , Intensive Care Units
OBJECTIVES: To develop a simple DNA sequencing test for simultaneous identification and antimicrobial resistance (AMR) detection of multiple sexually transmitted infections (STIs). METHODS: Real-time PCR (qPCR) was initially performed to identify Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) infections among a total of 200 vulvo-vaginal swab samples from female sex workers in Ecuador. qPCR positive samples plus qPCR negative controls for these STIs were subjected to single gene targeted PCR MinION-nanopore sequencing using the smartphone operated MinIT. RESULTS: Among 200 vulvo-vaginal swab samples 43 were qPCR positive for at least one of the STIs. Single gene targeted nanopore sequencing generally yielded higher pathogen specific read counts in qPCR positive samples than qPCR negative controls. Of the 26 CT, NG or MG infections identified by qPCR, 25 were clearly distinguishable from qPCR negative controls by read count. Discrimination of TV qPCR positives from qPCR negative controls was poorer as many had low pathogen loads (qPCR cycle threshold >35) which produced few specific reads. Real-time AMR profiling revealed that 3/3 NG samples identified had gyrA mutations associated with fluoroquinolone resistance, 2/10 of TV had mutations related to metronidazole resistance, while none of the MG samples possessed 23S rRNA gene mutations contributing to macrolide resistance. CONCLUSIONS: Single gene targeted nanopore sequencing for diagnosing and simultaneously identifying key antimicrobial resistance markers for four common genital STIs shows promise. Further work to optimise accuracy, reduce costs and improve speed may allow sustainable approaches for managing STIs and emerging AMR in resource poor and laboratory limited settings.
Drug Resistance, Bacterial/genetics , Mycoplasma genitalium/genetics , Neisseria gonorrhoeae/genetics , Sexually Transmitted Diseases/diagnosis , Trichomonas vaginalis/genetics , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , DNA Gyrase/genetics , Ecuador , Female , Fluoroquinolones/pharmacology , Fluoroquinolones/therapeutic use , Humans , Macrolides/pharmacology , Mycoplasma genitalium/drug effects , Mycoplasma genitalium/isolation & purification , Nanopore Sequencing , Neisseria gonorrhoeae/drug effects , Neisseria gonorrhoeae/isolation & purification , RNA, Ribosomal, 23S/chemistry , RNA, Ribosomal, 23S/genetics , RNA, Ribosomal, 23S/metabolism , Real-Time Polymerase Chain Reaction , Sex Workers , Sexually Transmitted Diseases/drug therapy , Sexually Transmitted Diseases/microbiology , Trichomonas vaginalis/drug effects , Trichomonas vaginalis/isolation & purification , Vagina/microbiology
Purpose: The aim of this study was to determine visual and anatomical outcome of perforating injuries due to shotgun pellet. Methods: This was a prospective observational study carried out between July 2016 and Jan 2019 at a tertiary care referral center in Srinagar, Jammu and Kashmir. A total of 172 eyes with perforating injuries of 170 patients were included in the study and were followed up for 6 months with best-corrected visual acuity, slit-lamp examination for status of anterior chamber and lens, fundus examination for status of retina and media, intraocular pressure measurements, and OCT (optical coherence tomography) and FFA (fundus fluoresceine angiography) in selected cases. The relative improvement of visual acuity after treatment was interpreted by applying paired two-tailed t tests. Prognostic significance of other variables was calculated using Chi-square and Chi-square for linear trend tests, for two dependent outcome variables of good outcome and poor outcome. Results: WHO category 4 visual impairment was found in 66 (38.4%) eyes, whereas category 0 was found in 24 (14%) of eyes. Retina was found to be attached 99 (57.6%) of study eyes. Conclusion: Perforating injury is a severe form of ocular trauma with grave consequences in terms of functional and anatomical outcome.
Eye Injuries , Eye Injuries/complications , Eye Injuries/diagnosis , Humans , Prospective Studies , Retina/diagnostic imaging , Retrospective Studies , Tomography, Optical Coherence , Visual Acuity
BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) patients typically receive either tubeless anesthesia or general endotracheal anesthesia (GETA). Patients receiving propofol-based total intravenous anesthesia (TIVA) are at higher risk of sedation-related adverse events (SRAEs) than patients receiving GETA, primarily due to the need for additional airway maneuvers. The increasing use of non-operating room (OR) anesthesia and the perception of a higher incidence of adverse outcomes in non-OR areas has led to the development of devices to improve safety while maintaining efficiency. The purpose of this study was to evaluate if the LMA Gastro™ could be used as a safe alternative to tubeless anesthesia for successfully completing ERCPs. METHODS: Eligible subjects were identified within the patient population at MD Anderson Cancer Center. Inclusion criteria consisted of adult patients (≥18 years old) scheduled for elective ERCP with TIVA. This was a prospective observational study in which the following data were collected: number of attempts and time to successful supraglottic airway (SGA) placement, vital signs, peripheral oxygen saturation (SpO2), median end-tidal CO2, practitioner satisfaction, and any complications. RESULTS: A total of 30 patients were included in this study. The overall rate of successful SGA placement within 3 attempts was 96.7% (95% confidence interval [CI], 82.8-99.9) or 29/30. The rate of successful ERCP with SGA placement within 3 attempts was 93.3% (95% CI, 77.9-99.2) or 28/30. Both the gastroenterologist and anesthesiologist reported satisfaction with the device in 90% of the cases (in 66.7% of the cases both anesthesiologist and gastroenterologist scored the device a 7/7 for satisfaction). Patients maintained an SpO2 of 95%-100% from induction to discharge, with the exception of 1 patient who had an SpO2 of 93%. The median end-tidal CO2 during the procedure for all patients was 35 mm Hg. Observed aspiration did not occur in any patient. Symptoms of hoarseness (13.3%), mouth soreness (6.7%), sore throat (6.6%), and minor bleeding/cuts/redness/change in taste to the tongue (3.3%) were determined through patient questioning before postanesthesia care unit (PACU) discharge. CONCLUSIONS: Our study suggests that the LMA Gastro might be a safe alternative for ERCP procedures. There was a high level of practitioner satisfaction. Only minor complications, such as hoarseness, mouth or throat soreness, or minor trauma to the tongue were experienced by patients. Similar incidences of complications may occur with GETA and tubeless anesthesia. The procedure was well tolerated by all patients; all patients maintained adequate oxygenation and required only minimal blood pressure support.
Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Laryngeal Masks/adverse effects , Adult , Aged , Aged, 80 and over , Airway Management , Anesthesiologists , Carbon Dioxide/blood , Cholangiopancreatography, Endoscopic Retrograde/methods , Female , Gastroenterologists , Hoarseness/epidemiology , Hoarseness/etiology , Humans , Male , Middle Aged , Oxygen/blood , Patient Safety , Pharyngitis/epidemiology , Pharyngitis/etiology , Postoperative Complications/epidemiology , Prospective Studies , Tongue/injuries
OBJECTIVES: 1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients. 2- To determine the salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL- 17 among COVID-19 patients subjected to 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles. TRIAL DESIGN: This will be a parallel group, quadruple blind-randomised controlled pilot trial with an add on laboratory based study. PARTICIPANTS: A non-probability, purposive sampling technique will be followed to identify participants for this study. The clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. The viral PCR tests will be done at main AKUH clinical laboratories whereas the immunological tests (cytokine analysis) will be done at the Juma research laboratory of AKUH. The inclusion criteria are laboratory-confirmed COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH. Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients will be excluded. Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus. INTERVENTION AND COMPARATOR: Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc.) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products Inc./ ActiveOxy® by Boumatic Inc.) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer. After each use, the patient is asked not to eat, drink, or rinse their mouth for the next 30 minutes. MAIN OUTCOMES: The primary outcome is the reduction in the intra-oral viral load confirmed with real time quantitative PCR. RANDOMISATION: The assignment to the study group/ allocation will be done using the sealed envelope method under the supervision of Clinical Trial Unit (CTU) of Aga Khan University, Karachi, Pakistan. The patients will be randomised to their respective study group (1:1:1:1:1 allocation ratio) immediately after the eligibility assessment and consent administration is done. BLINDING (MASKING): The study will be quadruple-blinded. Patients, intervention provider, outcome assessor and the data collection officer will be blinded. The groups will be labelled as A, B, C, D or E. The codes of the intervention will be kept in lock & key at the CTU and will only be revealed at the end of study or if the study is terminated prematurely. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. The present study will serve as a pilot trial. We intend to study 50 patients in five study groups with 10 patients in each study group. For details, please refer to Fig. 1 for details. TRIAL STATUS: Protocol version is 7.0, approved by the department and institutional ethics committees and clinical trial unit of the university hospital. Recruitment is planned to start as soon as the funding is sanctioned. The total duration of the study is expected to be 6 months i.e. August 2020-January 2021. TRIAL REGISTRATION: This study protocol was registered at www.clinicaltrials.gov on 10 April 2020 NCT04341688 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). Fig. 1 Flow diagram of study-participants' timeline.
Azadirachta , Betacoronavirus , Coronavirus Infections , Hydrogen Peroxide/administration & dosage , Pandemics , Plant Extracts/administration & dosage , Pneumonia, Viral , Povidone-Iodine/administration & dosage , Saline Solution, Hypertonic/administration & dosage , Viral Load , Adult , Anti-Infective Agents, Local/administration & dosage , Betacoronavirus/drug effects , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/immunology , Coronavirus Infections/therapy , Female , Hospitalization , Humans , Male , Monitoring, Immunologic/methods , Mouthwashes/administration & dosage , Nasal Lavage/methods , Pneumonia, Viral/diagnosis , Pneumonia, Viral/immunology , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic , SARS-CoV-2 , Viral Load/drug effects , Viral Load/methods
BACKGROUND: Prolonged invasive ventilation is common in patients with severe brain injury. Information on optimal management of extubation and on the use of tracheostomy in these patients is scarce. International guidelines regarding the ventilator liberation and tracheostomy are currently lacking. METHODS: The aim of 'Extubation strategies in Neuro-Intensive care unit patients and associations with Outcomes' (ENIO) study is to describe current management of weaning from invasive ventilation, focusing on decisions on timing of tracheal extubation and tracheostomy in intensive care unit (ICU) patients with brain injury. We conducted a prospective, international, multi-centre observational study enrolling patients with various types of brain injury, including trauma, stroke, and subarachnoid haemorrhage, with an initial Glasgow Coma Score equal or less than 12, and a duration of invasive ventilation longer than 24 hours from ICU admission. ENIO is expected to include at least 1,500 patients worldwide. The primary endpoint of the ENIO study is extubation success in the 48 hours following endotracheal tube removal. The primary objective is to validate a score predictive of extubation success. To accomplish this, the study population will be randomly divided to a development cohort (2/3 of the included patients) and a validation cohort (the remaining 1/3). Secondary objectives are: to determine the incidence of extubation success rate according to various time-frames (within 96 hours, >96 hours after extubation); to validate (existing) prediction scores for successful extubation according to various time-frames and definitions (i.e., tracheostomy as extubation failure); and to describe the current practices of extubation and tracheostomy, and their associations. DISCUSSION: ENIO will be the largest prospective observational study of ventilator liberation and tracheostomy practices in patients with severe brain injury undergoing invasive mechanical ventilation, providing a validated predictive score of successful extubation. TRIAL REGISTRATION: The ENIO study is registered in the Clinical Trials database: NCT03400904.
