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1.
JAMA ; : 1-12, 2019 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-31577037

RESUMO

Importance: End-of-life decisions occur daily in intensive care units (ICUs) around the world, and these practices could change over time. Objective: To determine the changes in end-of-life practices in European ICUs after 16 years. Design, Setting, and Participants: Ethicus-2 was a prospective observational study of 22 European ICUs previously included in the Ethicus-1 study (1999-2000). During a self-selected continuous 6-month period at each ICU, consecutive patients who died or had any limitation of life-sustaining therapy from September 2015 until October 2016 were included. Patients were followed up until death or until 2 months after the first treatment limitation decision. Exposures: Comparison between the 1999-2000 cohort vs 2015-2016 cohort. Main Outcomes and Measures: End-of-life outcomes were classified into 5 mutually exclusive categories (withholding of life-prolonging therapy, withdrawing of life-prolonging therapy, active shortening of the dying process, failed cardiopulmonary resuscitation [CPR], brain death). The primary outcome was whether patients received any treatment limitations (withholding or withdrawing of life-prolonging therapy or shortening of the dying process). Outcomes were determined by senior intensivists. Results: Of 13 625 patients admitted to participating ICUs during the 2015-2016 study period, 1785 (13.1%) died or had limitations of life-prolonging therapies and were included in the study. Compared with the patients included in the 1999-2000 cohort (n = 2807), the patients in 2015-2016 cohort were significantly older (median age, 70 years [interquartile range {IQR}, 59-79] vs 67 years [IQR, 54-75]; P < .001) and the proportion of female patients was similar (39.6% vs 38.7%; P = .58). Significantly more treatment limitations occurred in the 2015-2016 cohort compared with the 1999-2000 cohort (1601 [89.7%] vs 1918 [68.3%]; difference, 21.4% [95% CI, 19.2% to 23.6%]; P < .001), with more withholding of life-prolonging therapy (892 [50.0%] vs 1143 [40.7%]; difference, 9.3% [95% CI, 6.4% to 12.3%]; P < .001), more withdrawing of life-prolonging therapy (692 [38.8%] vs 695 [24.8%]; difference, 14.0% [95% CI, 11.2% to 16.8%]; P < .001), less failed CPR (110 [6.2%] vs 628 [22.4%]; difference, -16.2% [95% CI, -18.1% to -14.3%]; P < .001), less brain death (74 [4.1%] vs 261 [9.3%]; difference, -5.2% [95% CI, -6.6% to -3.8%]; P < .001) and less active shortening of the dying process (17 [1.0%] vs 80 [2.9%]; difference, -1.9% [95% CI, -2.7% to -1.1%]; P < .001). Conclusions and Relevance: Among patients who had treatment limitations or died in 22 European ICUs in 2015-2016, compared with data reported from the same ICUs in 1999-2000, limitations in life-prolonging therapies occurred significantly more frequently and death without limitations in life-prolonging therapies occurred significantly less frequently. These findings suggest a shift in end-of-life practices in European ICUs, but the study is limited in that it excluded patients who survived ICU hospitalization without treatment limitations.

2.
JAMA ; 322(3): 216-228, 2019 07 16.
Artigo em Inglês | MEDLINE | ID: mdl-31310297

RESUMO

Importance: The effects of intensive care unit (ICU) visiting hours remain uncertain. Objective: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium. Design, Setting and Participants: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018. Interventions: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation. Main Outcomes and Measures: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory). Results: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation. Conclusions and Relevance: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium. Trial Registration: ClinicalTrials.gov Identifier: NCT02932358.


Assuntos
Delírio/prevenção & controle , Família/psicologia , Unidades de Terapia Intensiva/organização & administração , Visitas a Pacientes , Ansiedade , Brasil , Esgotamento Profissional , Cuidados Críticos/psicologia , Estudos Cross-Over , Depressão , Feminino , Educação em Saúde , Hospitalização , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
4.
5.
BMJ Open ; 8(4): e021193, 2018 04 13.
Artigo em Inglês | MEDLINE | ID: mdl-29654049

RESUMO

INTRODUCTION: Flexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals. METHODS AND ANALYSIS: A cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals. ETHICS AND DISSEMINATION: The study protocol has been approved by the research ethics committee of all participant institutions. We aim to disseminate the findings through conferences and peer-reviewed journals. TRIAL REGISTRATION: NCT02932358.

10.
Virol J ; 14(1): 4, 2017 01 11.
Artigo em Inglês | MEDLINE | ID: mdl-28081720

RESUMO

BACKGROUND: Reporting new cases of enterovirus (EV)-D68-associated acute flaccid myelitis (AFM) is essential to understand how the virus causes neurological damage and to characterize EV-D68 strains associated with AFM. CASE PRESENTATION: A previously healthy 4-year-old boy presented with sudden weakness and limited mobility in his left arm. Two days earlier, he had an upper respiratory illness with mild fever. At admission, his physical examination showed that the child was febrile (38.5 °C) and alert but had a stiff neck and weakness in his left arm, which was hypotonic and areflexic. Cerebrospinal fluid (CSF) examination showed a mild increase in white blood cell count (80/mm3, 41% neutrophils) and a slightly elevated protein concentration (76 gm/dL). Bacterial culture and molecular biology tests for detecting viral infection in CSF were negative. The patient was then treated with intravenous ceftriaxone and acyclovir. Despite therapy, within 24 h, the muscle weakness extended to all four limbs, which exhibited greatly reduced mobility. Due to his worsening clinical prognosis, the child was transferred to our Pediatric Intensive Care Unit; at admission he was diagnosed with acute flaccid paralysis of all four limbs. Brain magnetic resonance imaging (MRI) was negative, except for a focal signal alteration in the dorsal portion of the medulla oblongata, also involving the pontine tegmentum, whereas spine MRI showed an extensive signal alteration of the cervical and dorsal spinal cord reported as myelitis. Signal alteration was mainly localized in the central grey matter, most likely in the anterior horns. Molecular biology tests performed on nasopharyngeal aspirate and on bronchoalveolar lavage fluid were negative for bacteria but positive for EV-D68 clade B3. Plasmapheresis was performed and corticosteroids and intravenous immunoglobulins were administered. After 4 weeks of treatment, the signs and symptoms of AFM were significantly reduced, although some weakness and tingling remained in the patient's four limbs. MRI acquired after 3 weeks showed that the previously reported alterations were no longer present. CONCLUSION: This case suggests that EV-D68 is a neurotropic agent that can cause AFM and strains are circulating in Europe. EV-D68 disease surveillance is required to better understand EV-D68 pathology and to compare various strains that cause AFM.


Assuntos
Enterovirus Humano D/isolamento & purificação , Infecções por Enterovirus/diagnóstico , Hipotonia Muscular/etiologia , Mielite/etiologia , Paralisia/etiologia , Pré-Escolar , Infecções por Enterovirus/patologia , Infecções por Enterovirus/virologia , Humanos , Itália , Masculino , Hipotonia Muscular/virologia , Mielite/virologia , Paralisia/virologia
13.
Pediatr Crit Care Med ; 18(2): e77-e85, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-27977540

RESUMO

OBJECTIVES: To translate and validate the EMpowerment of PArents in THe Intensive Care questionnaire to measure parent satisfaction and experiences in Italian PICUs. DESIGN: Prospective, multicenter study. SETTING: Four medical/surgical Italian PICUs in three tertiary hospitals. PATIENTS: Families of children, 0-16 years old, admitted to the PICUs were invited to participate. Inclusion criteria were PICU length of stay greater than 24 hours and good comprehension of Italian language by parents/guardians. Exclusion criteria were readmission within 6 months and parents of a child who died in the PICU. INTERVENTIONS: Distribution, at PICU discharge, of the EMpowerment of PArents in THe Intensive Care questionnaire with 65 items divided into five domains and a six-point rating scale: 1 " certainly no" to 6 "certainly yes." MEASUREMENTS AND MAIN RESULTS: Back and forward translations of the EMpowerment of PArents in THe Intensive Care questionnaire between Dutch (original version) and Italian languages were deployed. Cultural adaptation of the instrument was confirmed by a consultation with a representative parent group (n = 10). Totally, 150 of 190 parents (79%) participated in the study. On item level, 12 statements scored a mean below 5.0. The Cronbach's α, measured for internal consistency, on domain level was between 0.67 and 0.96. Congruent validity was measured by correlating the five domains with four gold standard satisfaction measures and showed adequate correlations (rs, 0.41-0.71; p < 0.05). No significant differences occurred in the nondifferential validity testing between three children's characteristics and the domains; excepting parents with a child for a surgical and planned admission were more satisfied on information and organization issues. CONCLUSIONS: The Italian version of the EMpowerment of PArents in THe Intensive Care questionnaire has satisfactory reliability and validity estimates and seems to be appropriate for Italian PICU setting. It is an important instrument providing benchmark data to be used in the process of quality improvement toward the development of a family-centered care philosophy within Italian PICUs.


Assuntos
Cuidados Críticos , Pais/psicologia , Satisfação Pessoal , Poder (Psicologia) , Indicadores de Qualidade em Assistência à Saúde , Inquéritos e Questionários , Traduções , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Pediátrica , Itália , Masculino , Estudos Prospectivos , Psicometria , Melhoria de Qualidade , Reprodutibilidade dos Testes
15.
Minerva Anestesiol ; 82(4): 479-85, 2016 04.
Artigo em Inglês | MEDLINE | ID: mdl-26154445

RESUMO

Clinical research is an essential component of medical activity, and this is also true in intensive care. Adequate information and consent are universally considered necessary for the protection of research subjects. However, in emergency situations, the majority of critical patients are unable to consent and a valid legal representative is often unavailable. The situation is even more complex in Italy, where the relevant legislation fails to specify how investigators should manage research in emergency or critical care setting when it involves incompetent patients who do not have an appointed legal representative. While special measures for the protection of incompetent subjects during emergency research are necessary, not allowing such research at all dooms critically ill patients to receive non-evidence-based treatments without the prospect of improvement. The recently-issued EU Regulation n. 536/2014 will probably help shed light on this situation. Indeed, it specifically addresses the issue of "research in emergency situations" and introduces detailed rules aimed at protecting patients while allowing research. In this article, we argue that obtaining informed consent during emergency research on incompetent subjects in unrealistic, and that in most cases substituted judgment on the part of a proxy carries major flaws. Strict criteria in evaluating the risk-benefit ratio of proposed intervention and a careful evaluation of the trial by a local or national Research Ethics Committee are perhaps the most practicable solution.


Assuntos
Cuidados Críticos , Serviços Médicos de Emergência , Consentimento Livre e Esclarecido , Competência Mental , Sujeitos da Pesquisa , Cuidados Críticos/legislação & jurisprudência , Estado Terminal , Emergências , Serviços Médicos de Emergência/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Itália , Competência Mental/legislação & jurisprudência , Estudos Multicêntricos como Assunto , Sujeitos da Pesquisa/legislação & jurisprudência , Medição de Risco
16.
Minerva Anestesiol ; 82(3): 359-68, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26372113

RESUMO

Donation after circulatory death (DCD) is a valuable option for the procurement of functioning organs for transplantation. Clinical results are promising and public acceptance is quite good in most western countries. Yet, although DCD is widespread in Europe, several problems still persist in Italy as well as in some other countries. This paper aims to describe the main clinical, organisational, ethical and legal issues at stake, bearing in mind the particular situation created by Italian legislation. Currently, as regards DCD, Italy is somewhat different from other countries. Therefore, every effort should be made for the safe and effective implementation of DCD programs: uncontrolled DCD programs should be promoted and encouraged, within the framework of shared and authoritative rules. At the same time, we need to tackle the question of controlled DCD, promoting debate among all involved subjects regarding the fundamental issues of end-of-life care within protocols that best integrate the highest standard of care for the dying and the legitimate interests of those awaiting a life-saving organ.


Assuntos
Doadores de Tecidos/ética , Doadores de Tecidos/legislação & jurisprudência , Obtenção de Tecidos e Órgãos/ética , Obtenção de Tecidos e Órgãos/legislação & jurisprudência , Atitude , Morte , Humanos , Itália , Assistência Terminal , Doadores de Tecidos/psicologia
17.
Muscle Nerve ; 53(1): 140-3, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26372816

RESUMO

INTRODUCTION: Guillain-Barré syndrome (GBS) may rarely manifest as a peripheral locked-in syndrome. METHODS: Clinical and instrumental features of a fulminant form of infantile GBS were assessed. RESULTS: After 2 days of rhinitis, a 6-month-old infant was intubated in the emergency room for sudden-onset respiratory failure. Neurological examination showed generalized areflexic flaccid paralysis with no detectable interaction, which resembled a coma. Brain MRI was normal. Lumbar puncture showed pleocytosis (43 cells/mm(3)) and herpes simplex virus 1 (HSV1) PCR positivity. EEG showed normal sleep-wake cycles, and EMG demonstrated nerve inexcitability. Acyclovir and immunoglobulins provided no benefit. After 1 week, lumbar puncture showed albuminocytological dissociation (protein 217 mg/dl). Plasmapheresis was then started, and progressive improvement occurred. At age 1 year, the child had recovered well with residual distal lower limb hyporeflexic weakness. CONCLUSIONS: A fulminant infantile GBS variant presenting as peripheral locked-in syndrome can be associated with HSV1 infection likely due to autoimmune cross-reactivity.


Assuntos
Síndrome de Guillain-Barré/complicações , Síndrome de Guillain-Barré/virologia , Herpes Simples/complicações , Herpesvirus Humano 1/patogenicidade , Eletroencefalografia , Eletromiografia , Humanos , Lactente , Masculino
18.
Minerva Anestesiol ; 82(1): 50-7, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26044935

RESUMO

BACKGROUND: Medical Emergency Teams (METs) are frequently involved in ethical issues associated to in-hospital emergencies, like decisions about end-of-life care and intensive care unit (ICU) admission. MET involvement offers both advantages and disadvantages, especially when an immediate decision must be made. We performed a survey among Italian intensivists/anesthesiologists evaluating MET's perspective on the most relevant ethical aspects faced in daily practice. METHODS: A questionnaire was developed on behalf of the Italian scientific society of anesthesia and intensive care (SIAARTI) and administered to its members. Decision making criteria applied by respondents when dealing with ethical aspects, the estimated incidence of conflicts due to ethical issues and the impact on the respondents' emotional and moral distress were explored. RESULTS: The questionnaire was completed by 327 intensivists/anesthesiologists. Patient life-expectancy, wishes, and the quality of life were the factors most considered for decisions. Conflicts with ward physicians were reported by most respondents; disagreement on appropriateness of ICU admission and family unpreparedness to the imminent patient death were the most frequent reasons. Half of respondents considered that in case of conflicts the final decision should be made by the MET. Conflicts were generally recognized as causing increased and moral distress within the MET members. Few respondents reported that dedicated protocols or training were locally available. CONCLUSION: Italian intensivists/anesthesiologists reported that ethical issues associated with in-hospital emergencies are occurring commonly and are having a significant negative impact on MET well-being. Conflicts with ward physicians happen frequently. They also conveyed that hospitals don't offer ethics training and have no protocols in place to address ethical issues.


Assuntos
Serviços Médicos de Emergência/ética , Equipe de Respostas Rápidas de Hospitais/ética , Atitude do Pessoal de Saúde , Estudos Transversais , Serviços Médicos de Emergência/estatística & dados numéricos , Ética Médica/educação , Pesquisas sobre Serviços de Saúde , Equipe de Respostas Rápidas de Hospitais/estatística & dados numéricos , Humanos , Itália , Inquéritos e Questionários , Assistência Terminal
19.
Pediatr Nephrol ; 31(5): 827-32, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26667238

RESUMO

BACKGROUND: To date, no study has investigated the use of vitamin K antagonists (VKA) in children undergoing chronic haemodialysis (HD) with a central venous catheter (CVC). METHODS: Consecutive patients aged <18 years with a newly placed tunnelled CVC for chronic HD were enrolled over a 3-year period. Children with active nephrotic syndrome or a history of venous thrombosis received warfarin (VKA group) with therapeutic target international normalised ratios of between 2.0 and 3.0. Patients at standard risk of CVC malfunction were not treated with VKA (standard group). The primary end-point was overall CVC survival. RESULTS: The VKA group consisted of nine patients (median age 10.6 years; range 1.2-15.3 years) with 11 CVC, and the standard group comprised eight patients (11.8 years; 6.1-17.3 years) with ten CVC. The 6- and 12-month CVC survival was significantly longer in the VKA group than in the standard group (100 vs. 60 % and 83.3 vs. 16.7 %, respectively; p < 0.05), with a median survival of 369 and 195 days, respectively (p < 0.05). None of the CVC in the VKA group required removal due to malfunction, as compared to four in the standard group. No major bleeding episodes occurred in either group. CONCLUSIONS: Therapy with VKA would appear to be safe in children on chronic HD and may improve CVC survival in patients at increased risk of CVC thrombosis.


Assuntos
Anticoagulantes/administração & dosagem , Obstrução do Cateter , Cateterismo Venoso Central , Trombose Venosa Profunda de Membros Superiores/prevenção & controle , Vitamina K/antagonistas & inibidores , Varfarina/administração & dosagem , Adolescente , Fatores Etários , Anticoagulantes/efeitos adversos , Obstrução do Cateter/etiologia , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/instrumentação , Cateteres de Demora , Cateteres Venosos Centrais , Criança , Pré-Escolar , Monitoramento de Medicamentos/métodos , Feminino , Humanos , Lactente , Coeficiente Internacional Normatizado , Masculino , Projetos Piloto , Diálise Renal , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Trombose Venosa Profunda de Membros Superiores/etiologia , Varfarina/efeitos adversos
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