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OBJECTIVES: Tracheostomy usually is performed to aid weaning from mechanical ventilation and facilitate rehabilitation and secretion clearance. Little is known about the safety of percutaneous tracheostomy in patients with severe COVID-19 supported on venovenous extracorporeal membrane oxygenation (VV-ECMO). This study aimed to investigate the bleeding risk of bedside percutaneous tracheostomy in patients with COVID-19 infection supported with VV-ECMO. DESIGN: A Retrospective review of electronic data for routine care of patients on ECMO. SETTING: Tertiary, university-affiliated national ECMO center. PARTICIPANTS: Patients with COVID-19 who underwent percutaneous tracheostomy while on VV-ECMO support. INTERVENTIONS: No intervention was conducted during this study. MEASUREMENTS AND MAIN RESULTS: Electronic medical records of 16 confirmed patients with COVID-19 who underwent percutaneous tracheostomy while on VV-ECMO support, including patient demographics, severity of illness, clinical variables, procedural complications, and outcomes, were compared with 16 non-COVID-19 patients. The SPSS statistical software was used for statistical analysis. The demographic data were compared using the chi-square test, and normality assumption was tested using the Shapiro-Wilk test. The indications for tracheostomy in all the patients were prolonged mechanical ventilation and sedation management. None of the patients suffered a life-threatening procedural complication within 48 hours. Moderate-to-severe bleeding was similar in both groups. There was no difference in 30- and 90-days mortality between both groups. As per routine screening results, none of the staff involved contracted COVID-19 infection. CONCLUSIONS: In this case series, percutaneous tracheostomy during VV-ECMO in patients with COVID-19 appeared to be safe and did not pose additional risks to patients or healthcare workers.
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COVID-19 , Oxigenación por Membrana Extracorpórea , Humanos , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/métodos , Traqueostomía/efectos adversos , Traqueostomía/métodos , COVID-19/terapia , Hemorragia/etiología , Respiración Artificial , Estudios RetrospectivosRESUMEN
In recent years, several studies have demonstrated that the experience derived from video games improves interventions that require technical skills. Airway management is crucial to anesthesiologists, requiring technical and non-technical skills. We evaluated the benefits of video games for video stylet-guided tracheal intubation, which allows the use of video technology in airway management of residents with anesthesiology training. In the present study, the residents working in the Department of Anesthesiology and Reanimation at the Health Sciences University of Kartal Dr. Lütfi Kirdar City Hospital in Istanbul were assigned to two groups. Active users who played video games on a regular basis formed study group (n = 14), while those who did not have video gaming habits were assigned to the control group (n = 15). Female patients with the American Society of Anesthesiologists (ASA) I and II classification undergoing elective open or laparoscopic gynecological surgery through tracheal intubation under general anesthesia were included in the study. Female patients elective open and laparoscopic gynecological surgery under GA were included in the study. Time to intubate the trachea by using video stylet in (Group 1) was found to be 29 s on average, and it was 59.9 s for Group 2 ( p < 0.01) The average number of tracheal intubation attempts was 1.1 in Group 1, and 1.4 in Group 2 (p = 0.19). Video gaming experience improves the visual attention.Those accustomed to playing with video games, video stylet- guided tracheal intubation, performed intubation in less time.
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Anestesiología , Juegos de Video , Femenino , Humanos , Intubación Intratraqueal , Laringoscopía , Tráquea , Grabación en VideoRESUMEN
BACKGROUND: Tracheal intubation for patients with COVID-19 is required for invasive mechanical ventilation. The authors sought to describe practice for emergency intubation, estimate success rates and complications, and determine variation in practice and outcomes between high-income and low- and middle-income countries. The authors hypothesized that successful emergency airway management in patients with COVID-19 is associated with geographical and procedural factors. METHODS: The authors performed a prospective observational cohort study between March 23, 2020, and October 24, 2020, which included 4,476 episodes of emergency tracheal intubation performed by 1,722 clinicians from 607 institutions across 32 countries in patients with suspected or confirmed COVID-19 requiring mechanical ventilation. The authors investigated associations between intubation and operator characteristics, and the primary outcome of first-attempt success. RESULTS: Successful first-attempt tracheal intubation was achieved in 4,017/4,476 (89.7%) episodes, while 23 of 4,476 (0.5%) episodes required four or more attempts. Ten emergency surgical airways were reported-an approximate incidence of 1 in 450 (10 of 4,476). Failed intubation (defined as emergency surgical airway, four or more attempts, or a supraglottic airway as the final device) occurred in approximately 1 of 120 episodes (36 of 4,476). Successful first attempt was more likely during rapid sequence induction versus non-rapid sequence induction (adjusted odds ratio, 1.89 [95% CI, 1.49 to 2.39]; P < 0.001), when operators used powered air-purifying respirators versus nonpowered respirators (adjusted odds ratio, 1.60 [95% CI, 1.16 to 2.20]; P = 0.006), and when performed by operators with more COVID-19 intubations recorded (adjusted odds ratio, 1.03 for each additional previous intubation [95% CI, 1.01 to 1.06]; P = 0.015). Intubations performed in low- or middle-income countries were less likely to be successful at first attempt than in high-income countries (adjusted odds ratio, 0.57 [95% CI, 0.41 to 0.79]; P = 0.001). CONCLUSIONS: The authors report rates of failed tracheal intubation and emergency surgical airway in patients with COVID-19 requiring emergency airway management, and identified factors associated with increased success. Risks of tracheal intubation failure and success should be considered when managing COVID-19.
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COVID-19 , Manejo de la Vía Aérea , Estudios de Cohortes , Humanos , Intubación Intratraqueal , Estudios Prospectivos , SARS-CoV-2RESUMEN
Microlaryngoscopy for benign vocal cord lesion excision is a procedure with good outcomes and relatively few complications that is performed worldwide. The anterior one-third of the vocal cords is a relatively common site to find benign polyps, and the excision of cases with adequate laryngeal exposure is relatively easy. However, they can sometimes present a challenge when laryngeal exposure is suboptimal, which leads to trouble in accessing the site. The factors that can lead to difficulties in laryngeal exposure are numerous, such as restricted mouth opening, limited neck extension, large tongue size, and others. The preoperative prediction of difficult laryngeal exposure (DLE) can be obtained by different scoring and grading systems. We have used the Laryngoscore in this case. However, management options for such cases remain limited. Here, we present a case that was managed using channeled cup forceps under fiberoptic endoscopy with the STRIVE-Hi technique used to administer anesthesia.
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Imminent upper airway obstruction due to life-threatening tracheal stenosis of any cause is a challenging situation. We present a challenging case of total thyroidectomy for a malignant, invasive, and highly vascularized thyroid carcinoma that has invaded the surrounding tissues, including the sternum and mediastinum, resulting in compression of the trachea with indentation. The patient presented with a significant symptomatic tracheal stenosis, the narrowest area of that was 4 mm. Airway management in such cases presents a particular challenge to the anesthesiologists, especially considering that the option of tracheostomy is very difficult most of the time due to the highly swollen thyroid and distorted anatomy. A meticulous history of the patient's illness had been taken, and a comprehensive preoperative evaluation was conducted, including construction of a 3D model airway, virtual endoscopy, and transnasal tracheoscopy. On the day of the surgery, the airway was managed through spontaneous respiration using intravenous anesthesia and the high-flow nasal oxygen (STRIVE-Hi) technique. It was then secured with intubation using a straw endotracheal tube (Tritube®) with an internal diameter (ID) of 2.4 mm and an outer diameter of 4.4 mm with the help of a fiberscope and D-MAC blade of a video laryngoscope. At the end of the procedure, the airway was checked with a fiber optic scope, which showed an improvement in the narrowed area. This enabled us to replace the Tritube with an adult cuffed ETT of size 6.5 mm ID, and the patient was transferred intubated to the surgical ICU. Two days later, the patient's tracheal diameter was evaluated with the help of a fiberoptic scope and extubated successfully in the operating theater.
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BACKGROUND: Cardiac arrest in hospital and out-of-hospital settings is associated with high mortality rates. Therefore, a bedside test that can predict resuscitation outcomes of cardiac arrest patients is of great value. Point-of-care ultrasound (POCUS) has the potential to be used as an effective diagnostic and prognostic tool during cardiac arrest, particularly in observing the presence or absence of cardiac activity. However, it is highly susceptible to "self-fulfilling prophecy" and is associated with prolonged cardiopulmonary resuscitation (CPR), which negatively impacts the survival rates of cardiac arrest patients. As a result, the current systematic review was created to assess the role of POCUS in predicting the clinical outcomes associated with out-of-hospital and in-hospital cardiac arrests. METHODS: The search for scientific articles related to our study was done either through an electronic database search (i.e., PubMed, Medline, ScienceDirect, Embase, and Google Scholar) or manually going through the reference list of the relevant articles. A quality appraisal was also carried out with the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2), and the prognostic test performance (sensitivity and sensitivity) was tabulated. RESULTS: The search criteria yielded 3984 articles related to our topic, of which only 22 were eligible for inclusion. After reviewing the literature, we noticed a wide variation in the definition of cardiac activity, and the statistical heterogeneity was high; therefore, we could not carry out meta-analyses. The tabulated clinical outcomes based on initial cardiac rhythm and definitions of cardiac activity showed highly inconsistent results. CONCLUSION: POCUS has the potential to provide valuable information on the management of cardiac arrest patients; however, it should not be used as the sole predictor for the termination of resuscitation efforts.
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Coronavirus disease 2019 (COVID-19) is an infectious disease caused by SARS-CoV-2, which was first discovered in Wuhan, China. The disease has grown into a global pandemic causing mild to moderate symptoms in most people. The disease can also exhibit serious illnesses, especially for patients with other chronic diseases such as cardiovascular diseases, diabetes, chronic respiratory disease, or cancer. In such cases of severe illness, high flow nasal oxygen (HFNO) has been used to provide oxygenation to COVID-19 patients. However, the efficiency of HFNO remains uncertain, prompting the conduction of this systematic review to evaluate the effectiveness of the therapy. A thorough search for relevant and original articles was carried out on five electronic databases, including ScienceDirect, PubMed, Cochrane Library, Embase, and Google Scholar. No time limitation was placed during the search as it included all the articles related to COVID-19 from 2019 to 2022. The search strategy utilized in this systematic review yielded 504 articles, of which only 10 met the eligibility criteria and were included. Our meta-analysis reveals that HFNO success rate was higher than HFNO failure rates (0.52 (95% CI; 0.47, 0.56) and 0.48 (95% CI; 0.44, 0.53), respectively), however, the difference was statistically insignificant. HFNO was associated with a significant decrease in mortality and intubation rates (0.28 (95% CI; 0.19, 0.39) and 0.28 (95% CI; 0.18, 0.41), respectively). Our statistical analysis has shown that significantly lower ROX index (5.07 ± 1.66, p = 0.028) and PaO2/FiO2 (100 ± 27.51, p = 0.031) are associated with HFNO failure, while a significantly lower respiratory rate (RR) (23.17 ± 4.167, p = 0.006) is associated with HFNO success. No statistically significant difference was observed in SpO2/FiO2 ratio between the HFNO success and failure groups (154.23 ± 42.74 vs. 124.025 ± 28.50, p = 0.62, respectively). Based on the results from our meta-analysis, the success or failure of HFNO in treating COVID-19 adult patients remains uncertain. However, HFNO has been shown to be an effective treatment in reducing mortality and intubation rates. Therefore, HFNO can be recommended for COVID-19 patients but with close monitoring and should be carried out by experienced healthcare workers.
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Oligoanalgesia, the undertreatment of trauma-related pain using standard analgesics in prehospital and emergency departments, has been extensively documented as one of the major challenges affecting the effective treatment of trauma-related pain. When administered in low doses, methoxyflurane has been highlighted by numerous medical works of literature to provide an effective, nonopioid, nonnarcotic treatment alternative to standard analgesics for prehospital and emergency department use. Low-dose methoxyflurane has been associated with fast-pain relief in adult patients manifesting moderate-to-severe pain symptoms. This systematic review and meta-analysis aimed to assess the clinical implication of low-dose methoxyflurane use in prehospital and emergency departments in adult patients with moderate-to-severe trauma-related pain. Moreover, the review aimed at assessing the risk stratification associated with using low-dose methoxyflurane in prehospital and emergency departments. The systematic review and meta-analysis performed a comprehensive search for pertinent literature assessing the implications and risks of using low-dose methoxyflurane in adult patients exhibiting moderate-to-severe trauma-related pain in prehospital settings. A comparison between the use of low-dose methoxyflurane and standard-of-care analgesics, placebo, in prehospital settings was reported in four clinically conducted randomized controlled trials (RCTs). These RCTs included the STOP! trial, InMEDIATE, MEDIATA, and the PenASAP trials. A meta-analysis comparing the time taken to achieve first pain relief on initial treatment of patients with moderate-to-severe trauma-related pain favored the use of low-dose methoxyflurane to the standard-of-care analgesics (mean difference = -6.63, 95% confidence interval = -7.37, -5.09) on time taken to establish effective pain relief. Low-dose methoxyflurane has been associated with superior and faster pain relief in prehospital and emergency departments in adult patients exhibiting moderate-to-severe trauma-related pain compared to other standard analgesics.
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Type II diabetes mellitus (T2DM) is a global epidemic affecting people of all ages in developed and developing countries. The disease is usually characterized by insulin resistance and glucose intolerance; therefore, oral antidiabetic drugs such as thiazolidinediones (TZDs) and biguanide metformin are used to counter these defects. Due to the varied action mechanisms of TZDs and Metformin, their effects on insulin sensitivity and glucose tolerance may differ. Therefore, the current study was carried out to compare the effects of Metformin and TZDs on insulin sensitivity and glucose tolerance among patients with T2DM. Two methods, including using a well-outlined search strategy in 5 electronic databases including ScienceDirect, Google Scholar, PubMed, Scopus, and Embase, and a manual search which involved going through the reference lists of studies from the electronic databases were used to retrieve studies published between 2000 and 2022. Additionally, data analysis of outcomes retrieved from the studies eligible for inclusion and the methodological quality was carried out using the Review Manager software (RevMan 5.4.1) and STATA. The meta-analysis has shown that TZDs have a significantly better overall effect on fasting plasma glucose (FPG) (SMD:0.61; 95% CI:0.06, 1.16: p = 0.03) and insulin sensitivity than Metformin (Mean QUICKI: 0.306 ± 0.019 vs. 0.316 ± 0.019, respectively; p=0.0003). However, the TZDs and Metformin offer the same effect on glycemic control as assessed using HBA1c levels (MD: 0.10; 95% CI: -0.20, 0.40; p = 0.52). TZDs offer better insulin sensitivity and glucose tolerance improvements compared to Metformin. This evidence contradicts the current guidelines by the American Diabetes Association/European Association for the Study of Diabetes (ADA/EASD) and the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE), which recommend the use of Metformin as the first-line drug monotherapy for patients with T2DM.
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Background: Emergency physicians play a major role in managing patients with hip fractures. The most commonly used pain management option is parenteral opioids. However, parenteral opioids are subjected to several adverse effects. New pain management techniques such as regional anesthesia are used as alternatives to parenteral opioids. Anatomical landmarks were used to administer regional anesthesia; however, ultrasound guidance has shown promising results with regional anesthesia. Objective: of the Review: The present study compares the efficacy of ultrasound-guided regional anesthesia (USGRA) to parenteral opioids in analgesia of hip fractures patients. Methods: A literature search for original and relevant articles carried out through six electronic databases, yielded 710 articles which were then assessed using the eligibility criteria resulting in 8 studies eligible for inclusion. Results: A Meta-analysis of the seven studies showed that ultrasound-guided femoral nerve block was more effective than parenteral opioids in relieving pain. Similarly, meta-analysis of data from two studies shows that US-guided FICB significantly reduced pain scores than parenteral opioids. A subgroup analysis of adverse events showed no significant difference in nausea/vomiting and respiratory complications. However, a subgroup analysis on hypotension showed that the incidence of hypotension was significantly lower in USGRA than parenteral opioids. The present study also revealed that patients in the USGRA group required less frequent rescue analgesia than the patients in the parenteral opioids group. Conclusion: Results of the present study show that USGRA is superior to parenteral opioids in reducing pain and the need for rescue analgesia in patients with hip fractures.
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Lacerations are common injuries managed by emergency department practitioners and are mostly witnessed in children. These lacerations usually require wound closure, which may result in one of the most unpleasant and painful childhood experiences. The pain can be minimized through topical anesthesia, such as a combination of lidocaine, epinephrine, and tetracaine (LET) and a eutectic mixture of local anesthetics (EMLA). The current study was carried out to demonstrate the efficacy of EMLA and LET in pediatric wound management. A thorough literature search was carried out without any time limitation on five electronic databases, including PubMed, Medline, Web of Science, Embase, and Google Scholar. Relevant studies from these databases and their references were scoured for additional studies. Study quality appraisal and data analysis were conducted using Review Manager software (RevMan 5.4.1). The literature search yielded 1651 articles of which only eight were eligible for inclusion in the present study. A meta-analysis of results from 3 studies showed that LET had a significant pain reduction than the control interventions (SMD: -0.46; 95% CI: -0.69, -0.23: p<0.0001). However, the pooled effect size of data from 3 studies showed EMLA had an insignificant difference with the control interventions (SMD: -0.79; 95% CI: -1.82, -0.24: p = 0.13). Similarly, no significant difference in the number of adverse reactions was reported in either EMLA (OR: 2.31; 95% CI: 0.67, 7.93; p = 0.18) or LET (OR: 0.99; 95% CI: 0.15, 6.50; p = 0.99) Our study suggests that the topical application of EMLA and LET effectively offers pain-free wound management among pediatric patients. However, the interventions are subject to adverse reactions that should be considered when managing the wounds.
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Procedural sedation and analgesia (PSA) is a treatment approach involving treating patients with agents with dissociative, sedative, or analgesic properties to suppress their consciousness to variable levels. Ketamine and propofol have been used historically for PSA. Because they each have their demerits, it was postulated that combining both drugs (ketofol) would result in a mixture with additive properties and lessen or eliminate the demerits attributed to each drug. The primary objective of this systematic review and meta-analysis is to compare ketamine alone and a combination of ketamine and propofol (ketofol) for procedural sedation and analgesia from an emergency perspective. A systematic search was conducted on published studies from the databases of Scopus, ScienceDirect, PubMed, Google Scholar, APA PsycInfo, and the Cochrane Central Register of Controlled Trial (CENTRAL) until July 2022. The articles that were published on the online databases were authored between January 2007 and 2018. The selected papers were scanned and examined to check whether they met the eligibility criteria for the study. The search produced six articles that were included in the systematic review and meta-analysis. All six articles that passed the eligibility criteria were viable for the analysis. All the trials focused on the effectiveness of ketofol versus ketamine for PSA from an emergency perspective. Ketofol was found to be safe and more effective in comparison to ketamine for PTA.
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Carpal tunnel syndrome (CTS) is the most common upper extremity neuropathy. The disease initially manifests as a sensory disorder in the form of paresthesia, numbness, or tingling of the fingers. The diagnosis is usually made based on history and clinical symptoms, which are confirmed using nerve conduction studies (NCS) and electromyography. More recently, ultrasound has gained more use in CTS diagnosis due to its advantages, which include patients' comfort during diagnosis, better visualization of anatomy and nerve forms directly, and cost-effectiveness. However, a literature review shows that the diagnostic accuracy of ultrasound over NCS is still in question; therefore, the present systematic review was carried out to compare the diagnostic accuracy of ultrasound to NCS and electromyography. A systematic literature search was performed on five electronic databases: PubMed, Medline, Web of Science, Embase, and Google Scholar. The search strategy limited the retrieval of literature published between 2000 and 2022. Of the 1098 articles retrieved from the electronic databases, only 12 met the inclusion criteria. A meta-analysis of outcomes from the included studies showed that the pooled sensitivity and specificity of the ultrasound were 0.80 (95% CI: 0.73, 0.88) and 0.90 (0.83, 0.96), respectively. On the other hand, combing the outcomes of electromyography and NCS resulted in sensitivity and specificity values of 0.89 (95% CI: 0.84, 0.95) and 0.77 (95% CI; 0.64, 0.90), respectively. The results show that ultrasound has comparable sensitivity and slightly higher specificity than NCS and electromyography; therefore, ultrasound can be used as an alternative diagnostic test for CTS. However, it cannot replace NCS and electromyography since more research needs to be done on doubtful and secondary cases of CTS.
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BACKGROUND: Annually, 10% of warfarin patients will likely need to stop warfarin prior to elective surgery to achieve a baseline international normalization ratio (INR) level (INR ≤ 1.2) at the time of the procedure. This study explores the influence of genetic and non-genetic factors on INR normalization in the Arab (major part of Near Eastern) population in preprocedural warfarin management. METHODS: An observational prospective cohort study was designed to recruit Arab patients taking warfarin and scheduled for an elective procedure. Two INR readings were recorded. DNA extraction and genotyping of variants in CYP2C9*2, CYP2C9*3, CYP4F2*3, VKORC1*2, and FII (rs5896) and FVII (rs3093229) genes using real-time polymerase chain reaction were performed. RESULTS: Data from 116 patients were included in the analysis. CYP2C9 and VKORC1 genetic variants carriers required lower maintenance dose compared to non-carriers. The analysis showed that ciprofloxacin, antiplatelet medications, and INR index (INR at visit 1) are the only factors associated with the INR decline rate. Also, the proportion of CYP2C9*3 carriers with normal INR (≤1.2) on the day of surgery was significantly lower than those with wild-type genotype (28% vs 60%, p=0.013). In addition, heparin bridging, INR target, and Sudanese nationality are significant predictors of INR normalization (≤1.2) on the day of the procedure. CONCLUSION: Despite the confirmed effect of genetic factors on warfarin maintenance dose, the study was not able to find a significant effect of any genetic factor on the rate of INR normalization possibly due to the small sample size. Index INR and interacting medications showed to be significant predictors of INR decline rate.
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BACKGROUND: The use of anticoagulant bridging remains controversial. This study was conducted to evaluate our warfarin periprocedural management in Qatar and investigate the associated clinical outcomes with such management. METHODS: A prospective cohort study was designed to describe the periprocedural clinical practice in warfarin patients in Qatar and to compare clinical safety and efficacy outcomes between anticoagulant bridging and nonbridging. RESULTS: 103 patients were recruited. Bridging occurred in 82% of the participants. No thromboembolic events were observed, while 39.1% of patients experienced bleeding events during the study period. The incidence of overall bleeding and major bleeding were numerically higher for bridging group compared to nonbridging but did not reach statistical significance ([30.6% vs 22.2%, Pâ¯=â¯0.478] and [12.9% vs 5.6%, Pâ¯=â¯0.375], respectively). CONCLUSION: Warfarin interruption and bridging are overwhelmingly used in warfarin-treated patients in Qatar. While bridging was numerically associated with increased bleeding events, there is no statistical difference in reported clinical events between bridging and nonbridging strategies.
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Anticoagulantes , Procedimientos Quirúrgicos Electivos , Hemorragia/inducido químicamente , Heparina , Tromboembolia/prevención & control , Warfarina , Adulto , Anciano , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Femenino , Hemorragia/etiología , Hemorragia/prevención & control , Heparina/efectos adversos , Heparina/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Atención Perioperativa , Estudios Prospectivos , Qatar , Tromboembolia/etiología , Resultado del Tratamiento , Warfarina/efectos adversos , Warfarina/uso terapéutico , Privación de TratamientoRESUMEN
Foreign body (FB) ingestion is commonly seen in the ear nose and throat (ENT) field, with different presentations and sequelae. FBs can arrest in the upper aerodigestive tract or continue further down into either the airway tract to the bronchus or the digestive tract to the intestines. The pathway of an FB depends on the size and shape of the FB and how sharp its edges are. Since the 20th century, the use of disposable stainless-steel needles in the oral cavity has proven to be an effective and safe method for performing various intraoral procedures like dental infiltration or a root canal wash. Complications from their use are rare. Generally, dental needle breakages are caused by patients biting the needle, incorrect injection techniques, or inadequate preventative measures. The sudden movement of a patient during a procedure is one of the most common causes of breakage. Occasionally, needles are swallowed during dental procedures such as a root canal. Here, we report a case of a patient that swallowed a broken needle during a dental procedure. A few days later, the patient presented with neck pain, swelling, and a FB sensation. When the patient presented, she claimed that her symptoms had onset after consuming a meal containing duck meat. Initially, the patient was diagnosed as having ingested a duck bone. However, intraoperatively, the FB was discovered to be an injection needle that had migrated from the throat to the neck.
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OBJECTIVES: This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the "Berlin" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings. TRIAL DESIGN: This is a prospective, randomized (1:1 ratio), parallel group feasibility study in adult patients with proven COVID-19 associated ARDS. PARTICIPANTS: All adult patients admitted to the ICU of Hamad Medical Corporation facilities in Qatar because of COVID-19 infection who develop moderate to severe ARDS are eligible. The inclusion criteria are above 18 years of age, proven COVID-19 infection, respiratory failure necessitating intubation and mechanical ventilation, ARDS with a P/F ratio of at least 200mmHg or less and a minimum PEEP 5cmH2O, BMI less 30 kg/ m2. The following exclusion criteria: no written consent, chronic respiratory disease, acute or chronic cardiovascular disease, pregnancy or need for special therapy (prone position and/or Extracorporeal membrane oxygenation). INTERVENTION AND COMPARATOR: After randomisation, the group A patients will be ventilated with the test-device for 48 hours. The settings will be started with the pre-existing-PEEP. The upper pressure will be determined to achieve a tidal volume of 6 ml/kg lean body mass, while the respiratory rate will be set to maintain an arterial pH above 7.2. In group B, the ventilator settings will be adjusted by the attending ICU team in accordance with lung-protective ventilation strategy. All other treatment will be unchanged and according to our local policies/guidelines. MAIN OUTCOMES: The primary end point is PaO2. As this is a dynamic parameter, we will record it every 6-8 hours and analyse it sequentially. RANDOMISATION: The study team screens the ventilated patients who fulfil the inclusion criteria and randomise using a 1:1 allocation ratio after consenting using a closed envelope method. The latter were prepared and sealed in advance by an independent person. BLINDING (MASKING): Due to the technical nature of the study (use of a specific ventilator) blinding is only possible for the data-analysts and the patients. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size calculation based on the assumption of an effect size (change in PaO2) of 1.5 SDS in the primary endpoint (PaO2), an intended power of 80%, an alpha error of 5% and an equal sample ratio results in n=7 patients needed to treat. However, to compensate for dropouts we will include 10 patients in each group, which means in total 20 patients. TRIAL STATUS: The local registration number is MRC-05-018 with the protocol version number 3. The date of approval is 14th April 2020. Recruitment began 28th May 2020 and is expected to end in September 2020. TRIAL REGISTRATION: The protocol was registered before starting subject recruitment under the title: "Flow controlled ventilation in ARDS associated with COVID-19" in ClinicalTrials.org with the registration number: NCT04399317 . Registered on 22 May 2020. 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.
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Betacoronavirus/patogenicidad , Infecciones por Coronavirus/terapia , Pulmón/virología , Neumonía Viral/terapia , Respiración Artificial , Síndrome de Dificultad Respiratoria/terapia , COVID-19 , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/virología , Estudios de Factibilidad , Interacciones Huésped-Patógeno , Humanos , Pulmón/fisiopatología , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/fisiopatología , Neumonía Viral/virología , Estudios Prospectivos , Qatar , Ensayos Clínicos Controlados Aleatorios como Asunto , Respiración Artificial/efectos adversos , Síndrome de Dificultad Respiratoria/diagnóstico , Síndrome de Dificultad Respiratoria/fisiopatología , Síndrome de Dificultad Respiratoria/virología , SARS-CoV-2 , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND AND AIMS: Human plasma protein fraction 5% (PPF5%) is an albumin-based colloid used to expand the plasma volume during volume deficiency. The current basic medical experimental study assessed in vitro coagulation of PPF5% solution and its effects on blood coagulation and chemistry. METHODS: The study involved 20 volunteers, and each volunteer donated 20-50 ml of fresh blood. Three dilutions of blood with PPF5% dilutions were prepared (30, 50, and 70%). The fibrinogen dose required to correct coagulation in the 50% diluted samples was assessed (two doses used). The thromboelastogram (TEG) measured the haemostatic parameters (fibrinogen level, initiation of coagulation [R time], kinetics [K], acceleration of coagulation [α angle], maximum amplitude [MA] and coagulation index [CI]), and the ABL gas analyser measured the blood chemistry changes. RESULTS: All dilutions showed significant TEG and blood chemistry changes when compared to controls. The two doses of fibrinogen corrected the clot formation speed with no significant difference in speed between the two doses. Acidosis measured by the strong ion gap (SID) and pH were significant for all dilutions when compared with the baseline. The 30% dilution remained within the lower normal acceptable value while 50% dilution was beyond the critical normal values. CONCLUSION: In vitro PPF5% to replace blood loss up to 50% dilution did not have significant coagulation and blood chemistry effects while coagulopathy should be expected in extreme dilutions (70%). Fibrinogen in a dose equivalent to 4 gm/70 kg adult improved clot strength at 50% dilution.