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OBJECTIVE: With the recent addition of airflow and respiratory effort channels, our group has observed central and mixed apnea events during drug-induced sleep endoscopy (DISE). We measured the frequency and timing of sentinel central and/or mixed events (SCents), as well as assessed for differences in velum, oropharynx, tongue, and epiglottis (VOTE) classification compared to obstructive events. STUDY DESIGN: Prospective single-cohort study. SETTING: Tertiary Care Academic Medical Center. METHODS: Patients underwent DISE between June 2020 and November 2022. Nasal airflow, thoracoabdominal effort belt signals, and videoendoscopy were simultaneously captured. Demographics, sleep study, and DISE data were compared among patients with and without SCents using Student's T tests or χ2 tests. RESULTS: On average, the cohort (n = 103) was middle-aged (53.5 ± 12.1 years), overweight (body mass index of 29.7 ± 5.3 kg/m2), and had severe obstructive sleep apnea (apnea-hypopnea index of 30.7 ± 18.7 events/h). Forty-seven patients (46%) were found to have at least 1 SCent. Among those with SCent, 45 (95.7%) transitioned to obstructive pathology after an average of 7.91 ± 2.74 minutes, with at least 95% of patients expected to do so within 12.57 minutes. Twenty-nine out of 47 patients (61.2% [95% confidence interval: 46.4.9%, 75.5%]) with SCent had meaningful differences between central/mixed and obstructive VOTE scores. CONCLUSION: Central events were present in almost half of our cohort. At least 95% of patients were expected to transition to obstructive events within 12 to 13 minutes of propofol initiation. In addition, over half of patients demonstrate significantly different VOTE scores between central and obstructive events. These factors should raise awareness of central events and scoring passive apneas during DISE and consider delaying VOTE scoring.
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Endoscopía , Apnea Obstructiva del Sueño , Humanos , Persona de Mediana Edad , Masculino , Femenino , Estudios Prospectivos , Endoscopía/métodos , Apnea Obstructiva del Sueño/epidemiología , Prevalencia , Polisomnografía , Adulto , SueñoRESUMEN
BACKGROUND: Postoperative nausea and vomiting (PONV) are adverse effects after surgery, which may increase the risk of complications. Aprepitant is a neurokinin-1 receptor blocker and has been shown to reduce chemotherapy-related nausea and vomiting and PONV. However, its role in endoscopic skull base surgery remains unclear. The purpose of this study was to evaluate the effect of aprepitant in reducing PONV in endoscopic transsphenoidal (TSA) pituitary surgery. METHODS: A retrospective chart review between July 2021 and January 2023 of 127 consecutive patients who underwent TSA was performed at a tertiary academic institution. Patients were divided into 2 groups based on preoperative aprepitant use. Two groups were matched based on known risk factors of PONV (age, sex, nonsmoking, and history of PONV). The primary outcome was the incidence of PONV. Secondary outcome measures included the number of anti-emetic use, length of stay, and postoperative cererebrospinal fluid (CSF) leak. RESULTS: After matching, 48 patients were included in each group. The aprepitant group demonstrated a significantly lower incidence of vomiting than the non-aprepitant group (2.1% vs 22.9%, p = 0.002). The number of nausea episodes and anti-emetic use decreased with aprepitant use (p < 0.05). There was no difference in the incidence of nausea, length of stay, or postoperative CSF leak. Multivariate analysis demonstrated that aprepitant decreased the incidence of postoperative vomiting with odds ratio of 0.107. CONCLUSION: Aprepitant may serve as a useful preoperative treatment to reduce PONV in patients undergoing TSA. Further studies are needed to evaluate its impact in other arenas of endoscopic skull base surgery.
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Antieméticos , Enfermedades de la Hipófisis , Humanos , Aprepitant/uso terapéutico , Náusea y Vómito Posoperatorios/epidemiología , Náusea y Vómito Posoperatorios/prevención & control , Náusea y Vómito Posoperatorios/inducido químicamente , Antieméticos/uso terapéutico , Estudios Retrospectivos , Morfolinas/uso terapéuticoRESUMEN
Communication failure is a common root cause of adverse clinical events. Problematic communication domains are difficult to decipher, and communication improvement strategies are scarce. This study compared perioperative incident reports (IR) identifying potential communication failures with the results of a contemporaneous peri-operative Relational Coordination (RC) survey. We hypothesised that IR-prevalent themes would map to areas-of-weakness identified in the RC survey. Perioperative IRs filed between 2018 and 2020 (n = 6,236) were manually reviewed to identify communication failures (n = 1049). The IRs were disaggregated into seven RC theory domains and compared with the RC survey. Report disaggregation ratings demonstrated a three-way inter-rater agreement of 91.2%. Of the 1,049 communication failure-related IRs, shared knowledge deficits (n = 479, 46%) or accurate communication (n = 465, 44%) were most frequently identified. Communication frequency failures (n = 3, 0.3%) were rarely coded. Comparatively, shared knowledge was the weakest domain in the RC survey, while communication frequency was the strongest, correlating well with our IR data. Linking IR with RC domains offers a novel approach to assessing the specific elements of communication failures with an acute care facility. This approach provides a deployable mechanism to trend intra- and inter-domain progress in communication success, and develop targeted interventions to mitigate against communication failure-related adverse events.
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Relaciones Interprofesionales , Gestión de Riesgos , Humanos , Encuestas y CuestionariosRESUMEN
Objectives: Determine variability in intra- and post-operative management of tracheostomies (trachs) at our institution as existing literature suggests that trachs are a frequent trigger for airway-related emergencies. Catalyze the development of an institution-wide protocols for trach care. Methods: A 39-question online survey was sent to 55 providers who perform open and percutaneous trachs at three of the hospitals within our large, urban, academic medical center. These providers were identified by surveillance of the operating room schedules for 1 year. Results: The survey was completed by 40 of the 53 eligible providers (75.5%). Response rate by question varied. Respondents included members of all departments that perform trachs at our institution (Otorhinolaryngology, Trauma Surgery, Thoracic Surgery, General Surgery, Cardiovascular Surgery and Interventional Pulmonology).While most responses demonstrated uniformity in practice, notable variations included the following: 80% of percutaneous trach providers stated that morbid obesity was not a contraindication to performing a trach outside of the operating room (n = 20) while 58% of open trach providers stated that morbid obesity was a contraindication; only 35% of open trach providers perform a Bjork flap (n = 350). The survey also identified significant variability in practice with regards to timing of trach suture removal. Discussion: Lack of uniformity was identified in several practices related to intra- and post-operative tracheostomy care. Results did, however, trend toward consensus in many areas. The results are being used to establish a more consistent approach to tracheostomy management across our institution to ensure standardization of practice amidst the rapidly evolving practices of trach placement. Implications for practice: With ongoing evolution in the methods of trach placement and its management, the concepts put forth here will be a resource for health care providers at other institutions to consider intra-institutional analysis and establishment of practice standardization.
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INTRODUCTION: Patients with COVID-19 ARDS require significant amounts of sedation and analgesic medications which can lead to longer hospital/ICU length of stay, delirium, and has been associated with increased mortality. Tracheostomy has been shown to decrease the amount of sedative, anxiolytic and analgesic medications given to patients. The goal of this study was to assess whether tracheostomy decreased sedation and analgesic medication usage, improved markers of activity level and cognitive function, and clinical outcomes in patients with COVID-19 ARDS. STUDY DESIGN AND METHODS: A retrospective registry of patients with COVID-19 ARDS who underwent tracheostomy creation at the University of Pennsylvania Health System or the Johns Hopkins Hospital from 3/2020 to 12/2020. Patients were grouped into the early (≤14 days, n = 31) or late (15 + days, n = 97) tracheostomy groups and outcome data collected. RESULTS: 128 patients had tracheostomies performed at a mean of 19.4 days, with 66% performed percutaneously at bedside. Mean hourly dose of fentanyl, midazolam, and propofol were all significantly reduced 48-h after tracheostomy: fentanyl (48-h pre-tracheostomy: 94.0â mcg/h, 48-h post-tracheostomy: 64.9â mcg/h, P = .000), midazolam (1.9 mg/h pre vs. 1.2 mg/h post, P = .0012), and propofol (23.3â mcg/kg/h pre vs. 8.4â mcg/kg/h post, P = .0121). There was a significant improvement in mobility score and Glasgow Coma Scale in the 48-h pre- and post-tracheostomy. Comparing the early and late groups, the mean fentanyl dose in the 48-h pre-tracheostomy was significantly higher in the late group than the early group (116.1â mcg/h vs. 35.6â mcg/h, P = .03). ICU length of stay was also shorter in the early group (37.0 vs. 46.2 days, P = .012). INTERPRETATION: This data supports a reduction in sedative and analgesic medications administered and improvement in cognitive and physical activity in the 48-h period post-tracheostomy in COVID-19 ARDS. Further, early tracheostomy may lead to significant reductions in intravenous opiate medication administration, and ICU LOS.
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Analgesia , COVID-19 , Humanos , Sistema de Registros , Estudios Retrospectivos , SARS-CoV-2 , TraqueostomíaRESUMEN
BACKGROUND: Airway rapid response (ARR) teams can be compiled of anesthesiologists, intensivists, otolaryngologists, general and thoracic surgeons, respiratory therapists, and nurses. The optimal composition of an ARR team is unknown but considered to be resource intensive. We sought to determine the type of technical procedures performed during an ARR activation to inform team composition. METHODS: A large urban quaternary academic medical center retrospective review (2016-2019) of adult ARR patients was performed. Analysis included ARR demographics, patient characteristics, characteristics of preexisting tracheostomies, incidence of concomitant conditions, and procedures completed during an ARR event. RESULTS: A total of 345 ARR patients with a median age of 60 years (interquartile range, 47-69 years) and a median time to ARR conclusion of 28 minutes (interquartile range, 14-47 minutes) were included. About 41.7% of the ARR had a preexisting tracheostomy. Overall, there were 130 procedures completed that can be performed by a general surgeon in addition to the 122 difficult intubations. These procedures included recannulation of a tracheostomy, operative intervention, new emergent tracheostomy or cricothyroidotomy, thoracostomy tube placement, initiation of extracorporeal membrane oxygenation, and pericardiocentesis. CONCLUSION: Highly technical procedures are common during an ARR, including procedures related to tracheostomies. Surgeons possess a comprehensive skill set that is unique and comprehensive with respect to airway emergencies. This distinctive skill set creates an important role within the ARR team to perform these urgent technical procedures. LEVEL OF EVIDENCE: Epidemiologic/prognostic, level III.
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Manejo de la Vía Aérea , Competencia Clínica/normas , Cuidados Críticos/métodos , Equipo Hospitalario de Respuesta Rápida , Traqueostomía , Centros Médicos Académicos/estadística & datos numéricos , Manejo de la Vía Aérea/métodos , Manejo de la Vía Aérea/normas , Atención Integral de Salud/métodos , Atención Integral de Salud/estadística & datos numéricos , Urgencias Médicas/epidemiología , Oxigenación por Membrana Extracorpórea/estadística & datos numéricos , Femenino , Equipo Hospitalario de Respuesta Rápida/organización & administración , Equipo Hospitalario de Respuesta Rápida/normas , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Necesidades , Grupo de Atención al Paciente/organización & administración , Pericardiocentesis/estadística & datos numéricos , Tiempo de Tratamiento , Traqueostomía/efectos adversos , Traqueostomía/métodos , Traqueostomía/estadística & datos numéricos , Estados Unidos/epidemiologíaRESUMEN
The perioperative care of adult patients undergoing free tissue transfer during head and neck surgical (microvascular) reconstruction is inconsistent across practitioners and institutions. The executive board of the Society for Head and Neck Anesthesia (SHANA) nominated specialized anesthesiologists and head and neck surgeons to an expert group, to develop expert consensus statements. The group conducted an extensive review of the literature to identify evidence and gaps and to prioritize quality improvement opportunities. This report of expert consensus statements aims to improve and standardize perioperative care in this setting. The Modified Delphi method was used to evaluate the degree of agreement with draft consensus statements. Additional discussion and collaboration was performed via video conference and electronic communication to refine expert opinions and to achieve consensus on key statements. Thirty-one statements were initially formulated, 14 statements met criteria for consensus, 9 were near consensus, and 8 did not reach criteria for consensus. The expert statements reaching consensus described considerations for preoperative assessment and optimization, airway management, perioperative monitoring, fluid management, blood management, tracheal extubation, and postoperative care. This group also examined the role for vasopressors, communication, and other quality improvement efforts. This report provides the priorities and perspectives of a group of clinical experts to help guide perioperative care and provides actionable guidance for and opportunities for improvement in the care of patients undergoing free tissue transfer for head and neck reconstruction. The lack of consensus for some areas likely reflects differing clinical experiences and a limited available evidence base.
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Anestesia/normas , Anestesiólogos/normas , Consenso , Atención Perioperativa/normas , Procedimientos de Cirugía Plástica/normas , Sociedades Médicas/normas , Anestesia/métodos , Testimonio de Experto , Cabeza/cirugía , Humanos , Cuello/cirugía , Atención Perioperativa/métodos , Procedimientos de Cirugía Plástica/métodosRESUMEN
BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic continues to surge in the United States and globally. OBJECTIVE: To describe the epidemiology of COVID-19-related critical illness, including trends in outcomes and care delivery. DESIGN: Single-health system, multihospital retrospective cohort study. SETTING: 5 hospitals within the University of Pennsylvania Health System. PATIENTS: Adults with COVID-19-related critical illness who were admitted to an intensive care unit (ICU) with acute respiratory failure or shock during the initial surge of the pandemic. MEASUREMENTS: The primary exposure for outcomes and care delivery trend analyses was longitudinal time during the pandemic. The primary outcome was all-cause 28-day in-hospital mortality. Secondary outcomes were all-cause death at any time, receipt of mechanical ventilation (MV), and readmissions. RESULTS: Among 468 patients with COVID-19-related critical illness, 319 (68.2%) were treated with MV and 121 (25.9%) with vasopressors. Outcomes were notable for an all-cause 28-day in-hospital mortality rate of 29.9%, a median ICU stay of 8 days (interquartile range [IQR], 3 to 17 days), a median hospital stay of 13 days (IQR, 7 to 25 days), and an all-cause 30-day readmission rate (among nonhospice survivors) of 10.8%. Mortality decreased over time, from 43.5% (95% CI, 31.3% to 53.8%) to 19.2% (CI, 11.6% to 26.7%) between the first and last 15-day periods in the core adjusted model, whereas patient acuity and other factors did not change. LIMITATIONS: Single-health system study; use of, or highly dynamic trends in, other clinical interventions were not evaluated, nor were complications. CONCLUSION: Among patients with COVID-19-related critical illness admitted to ICUs of a learning health system in the United States, mortality seemed to decrease over time despite stable patient characteristics. Further studies are necessary to confirm this result and to investigate causal mechanisms. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
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COVID-19/mortalidad , COVID-19/terapia , Enfermedad Crítica/mortalidad , Enfermedad Crítica/terapia , Neumonía Viral/mortalidad , Neumonía Viral/terapia , Choque/mortalidad , Choque/terapia , APACHE , Centros Médicos Académicos , Anciano , Femenino , Mortalidad Hospitalaria , Humanos , Unidades de Cuidados Intensivos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Pandemias , Readmisión del Paciente/estadística & datos numéricos , Pennsylvania/epidemiología , Neumonía Viral/virología , Respiración Artificial/estadística & datos numéricos , Estudios Retrospectivos , SARS-CoV-2 , Choque/virología , Tasa de SupervivenciaRESUMEN
IMPORTANCE: The COVID-19 pandemic is characterized by high transmissibility from patients with prolonged minimally- or asymptomatic periods, with a particularly increased risk of spread during aerosol-generating procedures, including endotracheal intubation. OBSERVATIONS: All patients presenting with upper airway obstruction due to angioedema during this time should be carefully managed in a way that is safest for both patient and provider. CONCLUSIONS: For patients requiring emergent airway management during the COVID-19 pandemic, minimization of aerosols while taking the necessary precautions to protect healthcare workers should are critical principles for their management.
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OBJECTIVE: To determine the outcomes of patients undergoing tracheostomy for COVID-19 and of healthcare workers performing these procedures. BACKGROUND: Tracheostomy is often performed for prolonged endotracheal intubation in critically ill patients. However, in the context of COVID-19, tracheostomy placement pathways have been altered due to the poor prognosis of intubated patients and the risk of transmission to providers through this highly aerosolizing procedure. METHODS: A prospective single-system multi-center observational cohort study was performed on patients who underwent tracheostomy after acute respiratory failure secondary to COVID-19. RESULTS: Of the 53 patients who underwent tracheostomy, the average time from endotracheal intubation to tracheostomy was 19.7 daysâ±â6.9 days. The most common indication for tracheostomy was acute respiratory distress syndrome, followed by failure to wean ventilation and post-extracorporeal membrane oxygenation decannulation. Thirty patients (56.6%) were liberated from the ventilator, 16 (30.2%) have been discharged alive, 7 (13.2%) have been decannulated, and 6 (11.3%) died. The average time from tracheostomy to ventilator liberation was 11.8 daysâ±â6.9 days (range 2-32 days). Both open surgical and percutaneous dilational tracheostomy techniques were performed utilizing methods to mitigate aerosols. No healthcare worker transmissions resulted from performing the procedure. CONCLUSIONS: Alterations to tracheostomy practices and processes were successfully instituted. Following these steps, tracheostomy in COVID-19 intubated patients seems safe for both patients and healthcare workers performing the procedure.
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COVID-19/terapia , Cuidados Críticos , Intubación Intratraqueal , Respiración Artificial , Traqueostomía , Adulto , Anciano , Anciano de 80 o más Años , COVID-19/complicaciones , COVID-19/mortalidad , Oxigenación por Membrana Extracorpórea , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
STUDY OBJECTIVE: Wrong-site nerve blocks (WSBs) are a significant, though rare, source of perioperative morbidity. WSBs constitute the most common type of perioperative wrong-site procedure reported to the Pennsylvania Patient Safety Authority. This systematic literature review aggregates information about the incidence, patient consequences, and conditions that contribute to WSBs, as well as evidence-based methods to prevent them. DESIGN: A systematic search of English-language publications was performed, using the PRISMA process. MAIN RESULTS: Seventy English-language publications were identified. Analysis of four publications reporting on at least 10,000 blocks provides a rate of 0.52 to 5.07 WSB per 10,000 blocks, unilateral blocks, or "at risk" procedures. The most commonly mentioned potential consequence was local anesthetic toxicity. The most commonly mentioned contributory factors were time pressure, personnel factors, and lack of site-mark visibility (including no site mark placed). Components of the block process that were addressed include preoperative nerve-block verification, nerve-block site marking, time-outs, and the healthcare facility's structure and culture of safety. DISCUSSION: A lack of uniform reporting criteria and divergence in the data and theories presented may reflect the variety of circumstances affecting when and how nerve blocks are performed, as well as the infrequency of a WSB. However, multiple authors suggest three procedural steps that may help to prevent WSBs: (1) verify the nerve-block procedure using multiple sources of information, including the patient; (2) identify the nerve-block site with a visible mark; and (3) perform time-outs immediately prior to injection or instillation of the anesthetic. Hospitals, ambulatory surgical centers, and anesthesiology practices should consider creating site-verification processes with clinician input and support to develop sustainable WSB-prevention practices.
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Anestésicos Locales/efectos adversos , Errores Médicos/prevención & control , Bloqueo Nervioso/efectos adversos , Seguridad del Paciente , Anestésicos Locales/administración & dosificación , Humanos , Errores Médicos/estadística & datos numéricos , Bloqueo Nervioso/métodos , Factores de TiempoRESUMEN
PURPOSE OF REVIEW: Provide a practical update on drug-induced sleep endoscopy (DISE) for anesthesia providers, which can also serve as a reference for those preparing to establish a DISE program. RECENT FINDINGS: New developments in surgical approaches to OSA and the growing global incidence of the condition have stimulated increased interest and demand for drug-induced sleep endoscopy. New techniques include transoral robotic surgery and hypoglossal nerve stimulation. Recent DISE literature has sought to address numerous debates including relevance of DISE findings to those during physiologic sleep and the most appropriate depth and type of sedation for DISE. Propofol and dexmedetomidine have supplanted midazolam as the drugs of choice for DISE. Techniques based on pharmacokinetic models of propofol are superior to empiric dosing with regard to risk of respiratory compromise and the reliability of dexmedetomidine to achieve adequate conditions for a complete DISE exam is questionable. SUMMARY: The role of DISE in surgical evaluation and planning for treatment of OSA continues to develop. Numerous questions as to the optimal anesthetic approach remain unanswered. Multicenter studies that employ a standardized approach using EEG assessment, pharmacokinetic-pharmacodynamic modelling, and objectively defined clinical endpoints will be helpful. There may be benefit to undertaking DISE studies in non-OSA patients.
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Endoscopía/métodos , Apnea Obstructiva del Sueño/diagnóstico , Anestesia/métodos , Electroencefalografía , Humanos , Propofol/administración & dosificación , Sueño/efectos de los fármacos , Sueño/fisiología , Apnea Obstructiva del Sueño/fisiopatologíaRESUMEN
BACKGROUND: Rapid response teams mobilize resources to patients experiencing acute deterioration. Failed airway management results in death or anoxic brain injury. A codified, systems-based approach to bring personnel and equipment to the bedside for multidisciplinary airway assessment and rescue was reflected in the initial implementation of an airway rapid response (ARR) team. METHODS: A retrospective review of records of 117 ARR events in a 40-month period (August 2011-November 2014) was undertaken at the Hospital of the University of Pennsylvania, a 789-bed, academic, urban, tertiary care, Level 1 trauma center. RESULTS: Of the 117 ARR events, 60 (51.3%) were called in the ICU, and 43 (36.8%) in the general ward. A definitive airway was secured in all patients for whom airway management was attempted. A new surgical airway was performed in five of the patients. Seven patients went to the operating room for airway management. Nine patients died or had care withdrawn shortly after the ARR. CONCLUSION: Difficult airway emergencies represent a small but critical element of airway rescue scenarios. Before the implementation of the ARR system, the process to bring the right team, equipment, expertise, and consensus on the right actions to critical airway emergencies was ad hoc. ARR activation, which brings multidisciplinary airway consultation, expert skills, and advanced airway equipment to the bedside, contributed to definitive airway management for surgical and nonsurgical airways. Performance of a bedside emergency surgical airway was uncommon. The ARR system represents a significant enhancement of the "anesthesia stat" system that typifies the airway emergency system at many institutions.
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Manejo de la Vía Aérea/métodos , Manejo de la Vía Aérea/normas , Protocolos Clínicos/normas , Equipo Hospitalario de Respuesta Rápida/organización & administración , Centros Traumatológicos/organización & administración , Adulto , Anciano , Índice de Masa Corporal , Femenino , Equipo Hospitalario de Respuesta Rápida/normas , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Traqueostomía/mortalidad , Traqueostomía/estadística & datos numéricos , Centros Traumatológicos/normasRESUMEN
OBJECTIVE: To systematically review the literature surrounding operating room-based in situ training in surgery. METHODS: A systematic review was conducted of MEDLINE. The review was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology, and employed the Population, Intervention, Comparator, Outcome (PICO) structure to define inclusion/exclusion criteria. The Kirkpatrick model was used to further classify the outcome of in situ training when possible. RESULTS: The search returned 308 database hits, and ultimately 19 articles were identified that met the stated PICO inclusion criteria. Operating room-based in situ simulation is used for a variety of purposes and in a variety of settings, and it has the potential to offer unique advantages over other types of simulation. Only one randomized controlled trial was conducted comparing in situ simulation to off-site simulation, which found few significant differences. One large-scale outcome study showed improved perinatal outcomes in obstetrics. CONCLUSIONS: Although in situ simulation theoretically offers certain advantages over other types of simulation, especially in addressing system-wide or environmental threats, its efficacy has yet to be clearly demonstrated.
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Cirugía General/educación , Quirófanos , Entrenamiento Simulado , Competencia Clínica , HumanosRESUMEN
OBJECTIVES: Management of early superficial lesions in the head and neck remains complex. We performed a phase 1 trial for high-grade premalignant and early superficial lesions of the head and neck using photodynamic therapy (PDT) with Levulan (ALA). MATERIALS AND METHODS: Thirty-five subjects with high grade dysplasia, carcinoma in situ, or microinvasive (⩽1.5mm depth) squamous cell carcinoma were enrolled. Cohorts of 3-6 patients were given escalating intraoperative light doses of 50-200J/cm(2) 4-6h after oral administration of 60mg/kg ALA. Light at 629-635nm was delivered in a continuous (unfractionated) or fractionated (two-part) schema. RESULTS: PDT was delivered to 30/35 subjects, with 29 evaluable. There was one death possibly due to the treatment. The regimen was otherwise tolerable, with a 52% rate of grade 3 mucositis which healed within several weeks. Other toxicities were generally grade 1 or 2, including odynophagia (one grade 4), voice alteration (one grade 3), and photosensitivity reactions. One patient developed grade 5 sepsis. With a median follow-up of 42months, 10 patients (34%) developed local recurrence; 4 of these received 50J/cm(2) and two each received 100, 150, and 200J/cm(2). Ten (34%) patients developed recurrence adjacent to the treated field. There was a 69% complete response rate at 3months. CONCLUSIONS: ALA-PDT is well tolerated. Maximum Tolerated Dose appears to be higher than the highest dose used in this study. Longer followup is required to analyze effect of light dose on local recurrence. High marginal recurrence rates suggest use of larger treatment fields.
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Ácido Aminolevulínico/efectos adversos , Carcinoma de Células Escamosas/tratamiento farmacológico , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Fotoquimioterapia/efectos adversos , Fármacos Fotosensibilizantes/efectos adversos , Lesiones Precancerosas/tratamiento farmacológico , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fotoquimioterapia/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Anesthesia and sedation are associated with paradoxical breathing. Respiratory inductance plethysmography (RIP) permits measurement of respiratory motion in clinical settings not conducive to spirometry, but correlation of RIP volume changes and spirometer flow in the time domain is degraded by the development of paradoxical breathing. The Hilbert-Huang transform (HHT) is a nonlinear signal analysis method that permits the instantaneous magnitude and phase of nonstationary signals to be estimated in the frequency domain. We hypothesized that these frequency domain estimates would provide higher correlation between RIP and spirometer signals than time domain signals during the transition between normal and paradoxical breathing. METHODS: From 51 patients undergoing sevoflurane anesthesia for minor procedures, a 5-minute epoch containing transitions between pressure support ventilation and spontaneous ventilation was selected for analysis. Pearson correlation for models based on HHT magnitude and phase was compared with models based on time domain signals. Bland-Altman analysis was performed to assess deviation from linearity in the models. RESULTS: For the 51 patients analyzed, the modulation of tidal volume over the epoch ranged from 30% to 215% of epoch mean. The coefficient of determination for time domain analysis was 0.62 ± 0.2 compared with 0.93 ± 0.07 for the HHT model incorporating phase. This improvement of 0.31 (99% confidence interval, 0.24-0.37) was significant (P < 0.0001). No trend was observed in prediction residuals. CONCLUSIONS: Under conditions of changing ventilation, HHT-derived magnitude and phase measures provide higher correlation with spirometry than those obtained with traditional time domain methods.