Intensivist-led ultrasound-guided percutaneous tracheostomy: a phase IV cohort study / Traqueostomia percutânea guiada por ultrassom conduzida por intensivistas: um estudo de coorte de fase IV

ABSTRACT Objective: To describe, with a larger number of patients in a real-world scenario following routine implementation, intensivist-led ultrasound-guided percutaneous dilational tracheostomy and the possible risks and complications of the procedure not identified in clinical trials. Methods: This was a phase IV cohort study of patients admitted to three intensive care units of a quaternary academic hospital who underwent intensivist-led ultrasound-guided percutaneous tracheostomy in Brazil from September 2017 to December 2021. Results: There were 4,810 intensive care unit admissions during the study period; 2,084 patients received mechanical ventilation, and 287 underwent tracheostomy, 227 of which were performed at bedside by the intensive care team. The main reason for intensive care unit admission was trauma, and for perform a tracheostomy it was a neurological impairment or an inability to protect the airways. The median time from intubation to tracheostomy was 14 days. Intensive care residents performed 76% of the procedures. At least one complication occurred in 29.5% of the procedures, the most common being hemodynamic instability and extubation during the procedure, with only 3 serious complications. The intensive care unit mortality was 29.1%, and the hospital mortality was 43.6%. Conclusion: Intensivist-led ultrasound-guided percutaneous tracheostomy is feasible out of a clinical trial context with outcomes and complications comparable to those in the literature. Intensivists can acquire this competence during their training but should be aware of potential complications to enhance procedural safety.

RESUMO Objetivo: Descrever, com um número maior de pacientes em um cenário do mundo real após a implementação rotineira, a traqueostomia percutânea guiada por ultrassom conduzida por intensivistas e os possíveis riscos e complicações do procedimento não identificados em estudos clínicos. Métodos: Trata-se de estudo de coorte de fase IV de pacientes internados em três unidades de terapia intensiva de um hospital acadêmico quaternário que foram submetidos a traqueostomia percutânea guiada por ultrassom conduzida por intensivistas no Brasil de setembro de 2017 a dezembro de 2021. Resultados: Entre as 4.810 admissões na unidade de terapia intensiva durante o período do estudo, 2.084 pacientes receberam ventilação mecânica, e 287 foram submetidos a traqueostomia, 227 das quais foram realizadas à beira do leito pela equipe de terapia intensiva. O principal motivo para a admissão na unidade de terapia intensiva foi trauma, e para a realização de uma traqueostomia foi comprometimento neurológico ou incapacidade de proteger as vias aéreas. O tempo médio entre a intubação e a traqueostomia foi de 14 dias. Residentes de terapia intensiva realizaram 76% dos procedimentos. Ao menos uma complicação ocorreu em 29,5% dos procedimentos, sendo instabilidade hemodinâmica e extubação durante o procedimento as complicações mais comuns, com apenas três complicações graves. A mortalidade na unidade de terapia intensiva foi de 29,1%, e a mortalidade hospitalar foi de 43,6%. Conclusão: A traqueostomia percutânea guiada por ultrassom conduzida por intensivistas é viável fora do contexto de um estudo clínico com resultados e complicações comparáveis aos da literatura. Os intensivistas podem adquirir essa competência durante seu treinamento, mas devem estar cientes das possíveis complicações para aumentar a segurança do procedimento.

Intensivist-led ultrasound-guided percutaneous tracheostomy: a phase IV cohort study.

OBJECTIVE: To describe, with a larger number of patients in a real-world scenario following routine implementation, intensivist-led ultrasound-guided percutaneous dilational tracheostomy and the possible risks and complications of the procedure not identified in clinical trials. METHODS: This was a phase IV cohort study of patients admitted to three intensive care units of a quaternary academic hospital who underwent intensivist-led ultrasound-guided percutaneous tracheostomy in Brazil from September 2017 to December 2021. RESULTS: There were 4,810 intensive care unit admissions during the study period; 2,084 patients received mechanical ventilation, and 287 underwent tracheostomy, 227 of which were performed at bedside by the intensive care team. The main reason for intensive care unit admission was trauma, and for perform a tracheostomy it was a neurological impairment or an inability to protect the airways. The median time from intubation to tracheostomy was 14 days. Intensive care residents performed 76% of the procedures. At least one complication occurred in 29.5% of the procedures, the most common being hemodynamic instability and extubation during the procedure, with only 3 serious complications. The intensive care unit mortality was 29.1%, and the hospital mortality was 43.6%. CONCLUSION: Intensivist-led ultrasound-guided percutaneous tracheostomy is feasible out of a clinical trial context with outcomes and complications comparable to those in the literature. Intensivists can acquire this competence during their training but should be aware of potential complications to enhance procedural safety.

Characteristics and outcomes of patients with COVID-19 admitted to the ICU in a university hospital in São Paulo, Brazil - study protocol

OBJECTIVES: We designed a cohort study to describe characteristics and outcomes of patients with coronavirus disease (COVID-19) admitted to the intensive care unit (ICU) in the largest public hospital in Sao Paulo, Brazil, as Latin America becomes the epicenter of the pandemic. METHODS: This is the protocol for a study being conducted at an academic hospital in Brazil with 300 adult ICU beds dedicated to COVID-19 patients. We will include adult patients admitted to the ICU with suspected or confirmed COVID-19 during the study period. The main outcome is ICU survival at 28 days. Data will be collected prospectively and retrospectively by trained investigators from the hospital's electronic medical records, using an electronic data capture tool. We will collect data on demographics, comorbidities, severity of disease, and laboratorial test results at admission. Information on the need for advanced life support and ventilator parameters will be collected during ICU stay. Patients will be followed up for 28 days in the ICU and 60 days in the hospital. We will plot Kaplan-Meier curves to estimate ICU and hospital survival and perform survival analysis using the Cox proportional hazards model to identify the main risk factors for mortality. ClinicalTrials.gov: NCT04378582. RESULTS: We expect to include a large sample of patients with COVID-19 admitted to the ICU and to be able to provide data on admission characteristics, use of advanced life support, ICU survival at 28 days, and hospital survival at 60 days. CONCLUSIONS: This study will provide epidemiological data about critically ill patients with COVID-19 in Brazil, which could inform health policy and resource allocation in low- and middle-income countries.

Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial.

BACKGROUND: Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. METHOD: The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. DISCUSSION: The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in line with the Consolidated Standards of Reporting Trials statement.

Septic pelvic thrombophlebitis of unknown origin: an ever threatening entity.

Septic pelvic thrombophlebitis (SPT) is a rare and severe entity, which may occur after abortion, delivery, gynecological diseases, or surgeries. Diagnosis is challenging when no risk factor is clearly present, since clinically, symptoms are non-specific. Nowadays, with the aid of imaging methods, diagnosis has become more achievable, but the treatment still bears some uncertainties. The authors present a fatal case of SPT in a young woman who sought medical care already presenting signs of septic shock, referring fever and non-characteristic abdominal pain. The patient evolved rapidly to multiple organ failure and respiratory distress, which was also due to septic pulmonary embolism. The autopsy confirmed the computed tomographic findings of a right ovarian vein septic thrombophlebitis and multiple septic pulmonary embolization foci. The patient did not present any of the recognized risk factors; neither did she present signs of pelvic inflammatory disease on admission or at autopsy. However, an intrauterine device was present. The authors call attention to this entity in the differential diagnosis of a woman with fever and abdominal pain, as well as for an empiric broad-spectrum antibiotic regimen in these cases.