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Importance: The optimal screening frequency and spontaneous breathing trial (SBT) technique to liberate adults from ventilators are unknown. Objective: To compare the effects of screening frequency (once-daily screening vs more frequent screening) and SBT technique (pressure-supported SBT with a pressure support level that was >0-≤8 cm H2O and a positive end-expiratory pressure [PEEP] level that was >0-≤5 cm H2O vs T-piece SBT) on the time to successful extubation. Design, Setting, and Participants: Randomized clinical trial with a 2 × 2 factorial design including critically ill adults who were receiving invasive mechanical ventilation for at least 24 hours, who were capable of initiating spontaneous breaths or triggering ventilators, and who were receiving a fractional concentration of inspired oxygen that was 70% or less and a PEEP level of 12 cm H2O or less. Recruitment was between January 2018 and February 2022 at 23 intensive care units in North America; last follow-up occurred October 18, 2022. Interventions: Participants were enrolled early to enable protocolized screening (more frequent vs once daily) to identify the earliest that patients met criteria to undergo pressure-supported or T-piece SBT lasting 30 to 120 minutes. Main Outcome and Measures: Time to successful extubation (time when unsupported, spontaneous breathing began and was sustained for ≥48 hours after extubation). Results: Of 797 patients (198 in the once-daily screening and pressure-supported SBT group, 204 in once-daily screening and T-piece SBT, 195 in more frequent screening and pressure-supported SBT, and 200 in more frequent screening and T-piece SBT), the mean age was 62.4 (SD, 18.4) years and 472 (59.2%) were men. There were no statistically significant differences by screening frequency (hazard ratio [HR], 0.88 [95% CI, 0.76-1.03]; P = .12) or by SBT technique (HR, 1.06 [95% CI, 0.91-1.23]; P = .45). The median time to successful extubation was 2.0 days (95% CI, 1.7-2.7) for once-daily screening and pressure-supported SBT, 3.1 days (95% CI, 2.7-4.8) for once-daily screening and T-piece SBT, 3.9 days (95% CI, 2.9-4.7) for more frequent screening and pressure-supported SBT, and 2.9 days (95% CI, 2.0-3.1) for more frequent screening and T-piece SBT. An unexpected interaction between screening frequency and SBT technique required pairwise contrasts that revealed more frequent screening (vs once-daily screening) and pressure-supported SBT increased the time to successful extubation (HR, 0.70 [95% CI, 0.50-0.96]; P = .02). Once-daily screening and pressure-supported SBT (vs T-piece SBT) did not reduce the time to successful extubation (HR, 1.30 [95% CI, 0.98-1.70]; P = .08). Conclusions and Relevance: Among critically ill adults who received invasive mechanical ventilation for more than 24 hours, screening frequency (once-daily vs more frequent screening) and SBT technique (pressure-supported vs T-piece SBT) did not change the time to successful extubation. However, an unexpected and statistically significant interaction was identified; protocolized more frequent screening combined with pressure-supported SBTs increased the time to first successful extubation. Trial Registration: ClinicalTrials.gov Identifiers: NCT02399267 and NCT02969226.
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Importance: Although most critically ill patients receive invasive mechanical ventilation (IMV), few studies have characterized how IMV is discontinued in practice. Objective: To describe practice variation in IMV discontinuation internationally, associations between initial discontinuation events and outcomes, and factors associated with the use of select discontinuation strategies and failed initial spontaneous breathing trials (SBTs). Design, Setting, and Participants: Prospective, multinational, observational study of critically ill adults who received IMV for at least 24 hours from 142 intensive care units (ICUs) in 19 countries within 6 regions (27 in Canada, 23 in India, 22 in the UK, 26 in Europe, 21 in Australia/New Zealand, and 23 in the US). Exposures: Receiving IMV. Main Outcomes and Measures: Primary analyses characterized types of initial IMV discontinuation events (extubation, SBT, or tracheostomy) and associations with clinical outcomes (including duration of ventilation, ICU and hospital mortality, and ICU and hospital length of stay). Secondary analyses examined the associations between SBT outcome and SBT timing and clinical outcomes. Results: Among 1868 patients (median [interquartile range] age, 61.8 [48.9-73.1] years; 1173 [62.8%] men) 424 (22.7%) underwent direct extubation, 930 (49.8%) had an initial SBT (761 [81.8%] successful), 150 (8.0%) underwent direct tracheostomy, and 364 (19.5%) died before a weaning attempt. Across regions, there was variation in the use of written directives to guide care, daily screening, SBT techniques, ventilator modes, and the roles played by clinicians involved in weaning. Compared with initial direct extubation, patients who had an initial SBT had higher ICU mortality (20 [4.7%] vs 96 [10.3%]; absolute difference, 5.6% [95% CI, 2.6%-8.6%]), longer duration of ventilation (median of 2.9 vs 4.1 days; absolute difference, 1.2 days [95% CI, 0.7-1.6]), and longer ICU stay (median of 6.7 vs 8.1 days; absolute difference, 1.4 days [95% CI, 0.8-2.4]). Patients whose initial SBT failed (vs passed) had higher ICU mortality (29 [17.2%] vs 67 [8.8%]; absolute difference, 8.4% [95% CI, 2.0%-14.7%]), longer duration of ventilation (median of 6.1 vs 3.5 days; absolute difference, 2.6 days [95% CI, 1.6-3.6]), and longer ICU stay (median of 10.6 vs 7.7 days; absolute difference, 2.8 days [95% CI, 1.1-5.2]). Compared with patients who underwent early initial SBTs, patients who underwent late initial SBTs (>2.3 days after intubation) had longer duration of ventilation (median of 2.1 vs 6.1 days; absolute difference, 4.0 days [95% CI, 3.7-4.5]), longer ICU stay (median of 5.9 vs 10.8 days; absolute difference, 4.9 days [95% CI, 4.0-6.3]), and longer hospital stay (median of 14.3 vs 22.8 days; absolute difference, 8.5 days [95% CI, 6.0-11.0]). Conclusions and Relevance: In this observational study of invasive mechanical ventilation discontinuation in 142 ICUs in Canada, India, the UK, Europe, Australia/New Zealand, and the US from 2013 to 2016, weaning practices varied internationally. Trial Registration: ClinicalTrials.gov Identifier: NCT03955874.
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Enfermedad Crítica/terapia , Desconexión del Ventilador/métodos , Adulto , Anciano , Femenino , Humanos , Unidades de Cuidados Intensivos , Modelos Lineales , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Respiración Artificial , Resultado del TratamientoRESUMEN
RATIONALE: Engagement promotes and supports the active participation of patients and families in health care and research to strengthen their influence on decision-making. We sought to characterize how citizens wish to be engaged in care and research in the intensive care unit (ICU). METHODS: Interviewers administered questionnaires to visitors in 3 adult ICUs and 1 pediatric ICU. RESULTS: We surveyed 202 (adult [n = 130] and pediatric [n = 72]) visitors. Adults and pediatric visitors prioritized 3 patient care topics (family involvement in rounds, improving communication between family members and health-care providers, and information transmission between health-care practitioners during patient transfers) and 2 research topics (evaluating prevention and recovery from critical illness). Preferred engagement activities included sharing personal experiences, identifying important topics and outcomes, and finding ways to make changes that respected their needs. Both respondent groups preferred to participate by completing electronic surveys or comment cards and answering questions on a website. Few respondents (<5%) wanted to participate in committees that met regularly. Although adult and pediatric respondents identified common facilitators and barriers to participation, they ranked them differently. Although both groups perceived engagement to be highly important, adult respondents were significantly less confident that their participation would impact care (7.6 ± 2.2 vs 8.3 ± 1.8; P = .01) and research (7.3 ± 2.4 vs 8.2 ± 2.0; P = .01) and were significantly less willing to participate in care (5.6 ± 2.9 vs 6.7 ± 3.0; P = .007) and research (4.7 ± 3.0 vs ± 5.8 ± 3.0; P = .02). CONCLUSIONS: Adult and pediatric visitors expressed comparable engagement preferences, identified similar facilitators and barriers, and rated engagement highly. Adult visitors were significantly less confident that their participation would be impactful and were significantly less willing to engage in care and research.
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Participación de la Comunidad/psicología , Cuidados Críticos/psicología , Investigación sobre Servicios de Salud , Unidades de Cuidado Intensivo Pediátrico , Unidades de Cuidados Intensivos , Atención al Paciente/psicología , Adulto , Niño , Femenino , Humanos , Masculino , Relaciones Profesional-Familia , Encuestas y CuestionariosRESUMEN
BACKGROUND: Although women at all career stages are more likely to leave academia than men, early-career women are a particularly high-risk group. Research supports that women are less likely than men to receive research funding; however, whether funding success rates vary based on research content is unknown. We addressed gender differences in funding success rates for applications directed to one or more of 13 institutes, representing research communities, over a 15-year period. METHODS AND FINDINGS: We retrospectively reviewed 55,700 grant and 4,087 personnel award applications submitted to the Canadian Institutes of Health Research. We analyzed application success rates according to gender and the primary institute selected by applicants, pooled gender differences in success rates using random effects models, and fitted Poisson regression models to assess the effects of gender, time, and institute. We noted variable success rates among grant applications directed to selected institutes and declining success rates over time. Women submitted 31.1% and 44.7% of grant and personnel award applications, respectively. In the pooled estimate, women had significantly lower grant success (risk ratio [RR] 0.89, 95% confidence interval [CI] 0.84-0.94; p < 0.001; absolute difference 3.2%) compared with men, with substantial heterogeneity (I2 = 58%). Compared with men, women who directed grants to the Institutes of Cancer Research (RR 0.86, 95% CI 0.78-0.96), Circulatory and Respiratory Health (RR 0.74, 95% CI 0.66-0.84), Health Services and Policy Research (RR 0.78, 95% CI 0.68-0.90), and Musculoskeletal Health and Arthritis (RR 0.80, 95% CI 0.69-0.93) were significantly less likely to be funded, and those who directed grants to the Institute of Aboriginal People's Health (RR 1.67, 95% CI 1.0-2.7) were more likely to be funded. Overall, women also had significantly lower personnel award success (RR 0.75, 95% CI 0.65-0.86; p < 0.001; absolute difference 6.6%). Regression modelling identified that the effect of gender on grant success rates differed by institute and not time. Study limitations include use of institutes as a surrogate identifier, variability in designation of primary institute, and lack of access to metrics reflecting applicants, coapplicants, peer reviewers, and the peer-review process. CONCLUSIONS: Gender disparity existed overall in grant and personnel award success rates, especially for grants directed to selected research communities. Funding agencies should monitor for gender differences in grant success rates overall and by research content.
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Investigación Biomédica/organización & administración , Investigación sobre Servicios de Salud/organización & administración , Investigadores , Apoyo a la Investigación como Asunto , Distribución por Sexo , Academias e Institutos , Adulto , Distinciones y Premios , Canadá , Selección de Profesión , Femenino , Organización de la Financiación , Humanos , Masculino , Persona de Mediana Edad , Distribución de Poisson , Salud Pública , Análisis de Regresión , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVES: It is unknown whether more frequent screening of invasively ventilated patients, identifies patients earlier for a spontaneous breathing trial, and shortens the duration of ventilation. We assessed the feasibility of conducting a large trial to evaluate screening frequency in critically ill adults in the North American context. DESIGN: We conducted two contemporaneous, multicenter, pilot, randomized controlled trials (the LibeRation from MEchanicaL VEntilAtion and ScrEening Frequency [RELEASE] and Screening Elderly PatieNts For InclusiOn in a Weaning [SENIOR] trials) to address concerns regarding the potential for higher enrollment, fewer adverse events, and better outcomes in younger patients. SETTING: Ten and 11 ICUs in Canada, respectively. PATIENTS: Parallel trials of younger (RELEASE < 65 yr) and older (SENIOR ≥ 65 yr) critically ill adults invasively ventilated for at least 24 hours. INTERVENTIONS: Each trial compared once daily screening to "at least twice daily" screening led by respiratory therapists. MEASUREMENTS AND MAIN RESULTS: In both trials, we evaluated recruitment (aim: 1-2 patients/month/ICU) and consent rates, reasons for trial exclusion, protocol adherence (target: ≥ 80%), crossovers (aim: ≤ 10%), and the effect of the alternative screening frequencies on adverse events and clinical outcomes. We included 155 patients (53 patients [23 once daily, 30 at least twice daily] in RELEASE and 102 patients [54 once daily, 48 at least twice daily] in SENIOR). Between trials, we found similar recruitment rates (1.32 and 1.26 patients/month/ICU) and reasons for trial exclusion, high consent and protocol adherence rates (> 92%), infrequent crossovers, and few adverse events. Although underpowered, at least twice daily screening was associated with a nonsignificantly faster time to successful extubation and more successful extubations but significantly increased use of noninvasive ventilation in both trials combined. CONCLUSIONS: Similar recruitment and consent rates, few adverse events, and comparable outcomes in younger and older patients support conduct of a single large trial in North American ICUs assessing the net clinical benefits associated with more frequent screening.
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Extubación Traqueal , Enfermedad Crítica , Selección de Paciente , Desconexión del Ventilador , Adulto , Anciano , Anciano de 80 o más Años , Protocolos Clínicos , Estudios de Factibilidad , Femenino , Humanos , Consentimiento Informado , Masculino , Persona de Mediana Edad , Proyectos Piloto , Prueba de Estudio Conceptual , Factores de TiempoRESUMEN
BACKGROUND: ENaC inhibition has been investigated as a CF treatment; however, small molecule inhibitors of ENaC lack efficacy and/or have shown dose-limiting hyperkalemia. SPX-101 is a novel, investigational small peptide (SPLUNC1 mimetic) that regulates ENaC density with the potential for efficacy without systemic effects. METHODS: Two trials are presented: The first was a Phase 1, 2-part, randomized, double-blind, placebo-controlled, ascending-dose study of nebulized SPX-101 in healthy adults. Part 1 evaluated 4 single doses of SPX-101 ranging from 20 to 240â¯mg. Part 2 evaluated a 14-day regimen of SPX-101 at 4 doses of SPX-101 ranging from 10 to 120â¯mg BID. Pharmacokinetics, adverse events, spirometry, vital signs, electrocardiograms, pulse oximetry, and clinical laboratory values were assessed. The second trial was a tolerability-confirming, Phase 1b, open-label study conducted in 5 adult subjects with CF. Ascending doses of SPX-101 inhalation solution (10â¯mg-120â¯mg BID) were administered for 7 days. Safety was assessed as described above. RESULTS: All 64 healthy volunteers (32 in each Part) completed the single and multiple dose study. SPX-101 was well tolerated with little/no systemic exposure and with no hyperkalemia. Adverse events were generally mild with reported respiratory events associated with the purported pharmacological activity of SPX-101. Tolerability of SPX-101 was similarly observed in adults with CF; all 5 subjects treated with SPX-101 completed the study. CONCLUSIONS: SPX-101 was well-tolerated across a range of doses and had little/no systemic exposure in healthy adults and adults with CF, thus supporting further study in patients with CF. CLINICALTRIAL. GOV REGISTRATION: NCT03056989.
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Fibrosis Quística/tratamiento farmacológico , Bloqueadores del Canal de Sodio Epitelial/farmacocinética , Bloqueadores del Canal de Sodio Epitelial/uso terapéutico , Administración por Inhalación , Adulto , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Bloqueadores del Canal de Sodio Epitelial/efectos adversos , Canales Epiteliales de Sodio , Femenino , Glicoproteínas/metabolismo , Voluntarios Sanos , Humanos , Masculino , Persona de Mediana Edad , Fosfoproteínas/metabolismoRESUMEN
OBJECTIVE: Little information exists to identify barriers to participation in pandemic research involving critically ill patients. We sought to characterize clinical research activity during the recent influenza A pandemic and to understand the experiences, beliefs, and practices of key stakeholders involved in pandemic research implementation. DESIGN: Cross-sectional, provincial postal questionnaire. SETTING: Level III ICUs. PARTICIPANTS: ICU administrators and research coordinators. MEASUREMENTS: We used rigorous survey methodology to identify potential respondents and to develop, test, and administer two-related questionnaires. MAIN RESULTS: We analyzed responses from 39 research coordinators and 139 administrators (response rates: 70.9% and 73.2%, respectively). Compared with non-influenza A studies, influenza A studies were less likely to be randomized trials and most often investigator-initiated and peer-review funded. Whereas both respondent groups felt that pandemic research would be helpful in providing care during future pandemics, research coordinators placed significantly greater importance on their ICU's participation in pandemic research. Both respondent groups expressed a need for rapid approval processes, designated funding for research personnel, adequate funding for start-up and patient screening, preapproved template protocols and consent forms, and clearer guidance regarding co-enrollment. Research coordinators acknowledged a need for alternative consent models to increase their capacity to participate in future pandemic research. More administrators expressed willingness to participate in the next pandemic if the required research resources were made available to them. CONCLUSIONS: Whereas research personnel and administrators support participation in pandemic ICU research, several modifiable barriers to participation exist. Pandemic research preparedness planning with regulatory bodies and dedicated funding to support research infrastructure, especially in community settings, are required to optimize future pandemic research participation.
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Planificación en Desastres/organización & administración , Gripe Humana/terapia , Unidades de Cuidados Intensivos/organización & administración , Pandemias/prevención & control , Programas Médicos Regionales/organización & administración , Actitud del Personal de Salud , Estudios Transversales , Servicio de Urgencia en Hospital/organización & administración , Investigación sobre Servicios de Salud/organización & administración , Humanos , Gripe Humana/epidemiología , Gripe Humana/prevención & control , Ontario/epidemiología , RegionalizaciónRESUMEN
OBJECTIVES: To describe international variation in ethics and contract processes, identify predictors of approval times, and reasons for nonparticipation in an international observational study of ventilation discontinuation practices. STUDY DESIGN AND SETTING: A nested cross-sectional survey of research personnel at 111 participating sites (representing 142 intensive care units [ICUs]) from six geographic regions (Canada, India, the United Kingdom, Europe, Australia/New Zealand, and the United States). RESULTS: We analyzed responses from 80 sites (72.1% response rate). A single local or central approval was required at 34/80 (42.5%) and 23/80 (28.75%), respectively. Of those requiring central ethics approval, 20/23 (87.0%) sites required an additional approval. Sites with central vs. other ethics approval processes had significantly longer times to ethics approval (176 vs. 42 days; P < 0.0001). The median time to contract execution was 140 days (range: 11-1,215) with sites in India and the United States having the shortest and longest times to contract execution, respectively. We did not identify independent predictors of approval times. Of 190 sites that initially agreed to participate, 78 (41%) sites (89 ICUs) were ultimately unable to participate. CONCLUSION: International ethics and contract approval times were lengthy and highly variable. Central ethics review processes significantly increased approval times.
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Comités de Ética en Investigación , Respiración Artificial , Humanos , Estados Unidos , Estudios Transversales , Europa (Continente) , Australia , Reino UnidoRESUMEN
PURPOSE: The aim of this study was to characterize differences in directives to limit treatments and discontinue invasive mechanical ventilation (IMV) in elderly (65-80 years) and very elderly (> 80 years) intensive care unit (ICU) patients. METHODS: We prospectively described new written orders to limit treatments, IMV discontinuation strategies [direct extubation, direct tracheostomy, spontaneous breathing trial (SBT), noninvasive ventilation (NIV) use], and associations between initial failed SBT and outcomes in 142 ICUs from 6 regions (Canada, India, United Kingdom, Europe, Australia/New Zealand, United States). RESULTS: We evaluated 788 (586 elderly; 202 very elderly) patients. Very elderly (vs. elderly) patients had similar withdrawal orders but significantly more withholding orders, especially cardiopulmonary resuscitation and dialysis, after ICU admission [67 (33.2%) vs. 128 (21.9%); p = 0.002]. Orders to withhold reintubation were written sooner in very elderly (vs. elderly) patients [4 (2-8) vs. 7 (4-13) days, p = 0.02]. Very elderly and elderly patients had similar rates of direct extubation [39 (19.3%) vs. 113 (19.3%)], direct tracheostomy [10 (5%) vs. 40 (6.8%)], initial SBT [105 (52%) vs. 302 (51.5%)] and initial successful SBT [84 (80%) vs. 245 (81.1%)]. Very elderly patients experienced similar ICU outcomes (mortality, length of stay, duration of ventilation) but higher hospital mortality [26 (12.9%) vs. 38 (6.5%)]. Direct tracheostomy and initial failed SBT were associated with worse outcomes. Regional differences existed in withholding orders at ICU admission and in withholding and withdrawal orders after ICU admission. CONCLUSIONS: Very elderly (vs. elderly) patients had more orders to withhold treatments after ICU admission and higher hospital mortality, but similar ICU outcomes and IMV discontinuation. Significant regional differences existed in withholding and withdrawal practices.
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Ventilación no Invasiva , Respiración Artificial , Humanos , Anciano , Diálisis Renal , Desconexión del Ventilador , Respiración , Unidades de Cuidados Intensivos , Extubación TraquealRESUMEN
BACKGROUND: Benzodiazepines are considered first-line treatment for patients experiencing severe acute alcohol withdrawal syndrome (sAAWS). Although several medications have been evaluated as potential adjuvant treatments for sAAWS, barbiturates show particular promise. OBJECTIVE: In the PHENOMANAL trial, we will assess the feasibility of conducting an allocation-concealed, quadruple-blinded, randomized controlled trial (RCT) comparing symptom-triggered benzodiazepine therapy with either a single dose of adjuvant intravenous (IV) phenobarbital (7.5 mg/kg of ideal body weight) or a single dose of matching IV placebo for patients with sAAWS. METHODS: We will recruit adult patients from the Emergency Department, Intensive Care Unit, or hospital wards with a Clinical Institute of Withdrawal - Adult revised (CIWA-Ar) score of 16 or more after receipt of at least 60 mg of diazepam or equivalent within 16 h of diagnosis of sAAWS, and an anticipated need for hospitalization. We will randomize participants (n=39) in a 2:1 manner to treatment and placebo groups, respectively. The primary objective of the PHENOMANAL pilot trial will be to demonstrate our ability to recruit the desired population over the trial period. As secondary objectives, we will evaluate clinician compliance with the treatment protocols, assess crossover rates from the placebo arm to the treatment arm, and obtain preliminary estimates of treatment effect. All trial participants will be followed for 7 days or until hospital discharge. RELEVANCE: The PHENOMANAL trial is novel in investigating a new treatment for a common and understudied condition, repurposing an existing medication for a novel indication, and addressing an important evidence gap. Through conduct of the multidisciplinary pilot trial, we aim to advance methodology in acute care research through the use of a hybrid consent model and inform the design of a large-scale trial. TRIAL REGISTRATION: ClinicalTrials.gov Registration NCT03586089 ; first registered July 13, 2018.
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OBJECTIVE: To examine the effects of the extent of endoscopic sinus surgery (ESS) on pulmonary health, including the pulmonary exacerbations and lung function in patients with cystic fibrosis (CF). STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary health care center. SUBJECTS AND METHODS: A retrospective review of patients with CF who underwent ESS at St. Michael's Hospital between 1999 and 2016 was performed. Two groups of patients were identified based on the surgical extent: (1) complete (maxillary antrostomy, complete ethmoidectomy, sphenoidotomy, and frontal sinusotomy) and (2) limited (any ESS that involved less than complete). Primary outcomes included the number of pulmonary exacerbations (the use of oral or intravenous [IV] antibiotics), number of hospital admissions and hospital days during a 2-year pre- and postoperative period, and pulmonary function outcomes during a 1-year pre- and postoperative period. RESULTS: There were 70 procedures (30 complete and 40 limited) among 57 patients. Baseline characteristics were similar between the groups. Complete ESS group had a significant reduction in the oral antibiotic use compared to the limited ESS group (median, -1.0 [interquartile range (IQR), -2 to 0] in complete vs 0 [IQR, -1 to 1] in limited, P = .028). There was no difference in the use of IV antibiotics, number and duration of admissions, or rate of lung function change between the 2 groups. CONCLUSION: Complete ESS may reduce mild forms of pulmonary exacerbations as shown in the decreased use of oral antibiotics. Overall, ESS does not significantly modify pulmonary outcomes in patients with CF.
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Endoscopía/métodos , Rinitis/cirugía , Sinusitis/cirugía , Adolescente , Adulto , Antibacterianos/uso terapéutico , Enfermedad Crónica , Estudios de Cohortes , Fibrosis Quística/complicaciones , Femenino , Humanos , Enfermedades Pulmonares/epidemiología , Enfermedades Pulmonares/prevención & control , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Otorrinolaringológicos/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Estudios Retrospectivos , Rinitis/complicaciones , Sinusitis/complicaciones , Resultado del Tratamiento , Adulto JovenRESUMEN
INTRODUCTION: Research supports the use of specific strategies to discontinue mechanical ventilation (MV) in critically ill patients. Little is known about how clinicians actually wean and discontinue MV in practice or the association between different discontinuation strategies and outcomes. The primary objective of this study is to describe international practices in the use of (1) daily screening for readiness to discontinue MV, (2) modes of MV used before initial discontinuation attempts, (3) weaning and spontaneous breathing trial (SBT) protocols, (4) SBT techniques and (5) sedation and mobilisation practices to facilitate weaning and discontinuation. The secondary objectives are to identify patient characteristics and time-dependent factors associated with use of selected strategies, investigate associations between SBT outcome (failure vs success) and outcomes, explore differences between patients who undergo an SBT early versus later in their intensive care unit (ICU) stay, and investigate the associations between different SBT techniques and humidification strategies on outcomes. METHODS AND ANALYSIS: We will conduct an international, prospective, observational study of MV discontinuation practices among critically ill adults who receive invasive MV for at least 24 hours at approximately 150 ICUs in six geographic regions (Canada, USA, UK, Europe, India and Australia/New Zealand). Research personnel at participating ICUs will collect demographic data, data to characterise the initial strategy or event that facilitated discontinuation of MV (direct extubation, direct tracheostomy, initial successful SBT, initial failed SBT or death before any attempt could be made), clinical outcomes and site information. We aim to collect data on at least 10 non-death discontinuation events in each ICU (at least 1500 non-death discontinuation events). ETHICS AND DISSEMINATION: This study received Research Ethics Approval from St. Michael's Hospital (11-024) Research ethics approval will be sought from all participating sites. The results will be disseminated through publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03955874.
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Enfermedad Crítica/terapia , Vías Clínicas/normas , Respiración Artificial/métodos , Traqueostomía/métodos , Desconexión del Ventilador/métodos , Privación de Tratamiento/normas , Adulto , Cuidados Críticos/métodos , Cuidados Críticos/normas , Femenino , Humanos , Masculino , Monitoreo Fisiológico/métodos , Estudios Observacionales como Asunto , Evaluación de Procesos y Resultados en Atención de Salud , Pautas de la Práctica en Medicina , Factores de TiempoRESUMEN
RATIONALE: In critically ill patients receiving invasive mechanical ventilation (MV), research supports the use of daily screening to identify patients who are ready to undergo a spontaneous breathing trial (SBT) followed by conduct of an SBT. However, once daily (OD) screening is poorly aligned with the continuous care provided in most intensive care units (ICUs) and the best SBT technique for clinicians to use remains controversial. OBJECTIVES: To identify the optimal screening frequency and SBT technique to wean critically ill adults in the ICU. METHODS: We aim to conduct a multicenter, factorial design randomized controlled trial with concealed allocation, comparing the effect of both screening frequency (once versus at least twice daily [ALTD]) and SBT technique (Pressure Support [PS] + Positive End-Expiratory Pressure [PEEP] vs T-piece) on the time to successful extubation (primary outcome) in 760 critically ill adults who are invasively ventilated for at least 24 h in 20 North American ICUs. In the OD arm, respiratory therapists (RTs) will screen study patients between 06:00 and 08:00 h. In the ALTD arm, patients will be screened at least twice daily between 06:00 and 08:00 h and between 13:00 and 15:00 h with additional screens permitted at the clinician's discretion. When the SBT screen is passed, an SBT will be conducted using the assigned technique (PS + PEEP or T-piece). We will follow patients until successful extubation, death, ICU discharge, or until day 60 after randomization. We will contact patients or their surrogates six months after randomization to assess health-related quality of life and functional status. RELEVANCE: The around-the-clock availability of RTs in North American ICUs presents an important opportunity to identify the optimal SBT screening frequency and SBT technique to minimize patients' exposure to invasive ventilation and ventilator-related complications. TRIAL REGISTRATION: Clinical Trials.gov, NCT02399267 . Registered on Nov 21, 2016 first registered.
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Enfermedad Crítica/terapia , Pulmón/fisiopatología , Respiración Artificial , Respiración , Pruebas de Función Respiratoria , Desconexión del Ventilador , Extubación Traqueal , Humanos , Estudios Multicéntricos como Asunto , América del Norte , Valor Predictivo de las Pruebas , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la Función , Factores de Tiempo , Resultado del TratamientoRESUMEN
RATIONALE: Randomized trials and meta-analyses have informed several aspects of weaning. Results are rarely replicated in practice, as evidence is applied in intensive care units that differ from the settings in which it was generated. OBJECTIVES: We aimed to: 1) describe weaning practice variation (identifying weaning candidates, conducting spontaneous breathing trials, using ventilator modes, and other aspects of care during weaning); 2) characterize regional differences in weaning practices; and 3) identify factors associated with practice variation. METHODS: We conducted a cross-sectional, self-administered, international postal survey of adult intensivist members of regional critical care societies from six geographic regions, including Canada, India, the United Kingdom, Europe, Australia/New Zealand, and the United States. We worked with societies to randomly select potential respondents from membership lists and administer questionnaires with the goal of obtaining 200 responses per region. RESULTS: We analyzed 1,144 questionnaires (Canada, 156; India, 136; United Kingdom, 219; Europe, 260; Australia/New Zealand, 196; United States, 177). Across regions, most respondents screened patients once daily to identify spontaneous breathing trials candidates (regional range, 70.0%-95.6%) and less often screened twice daily (range, 12.2%-33.1%) or more than twice daily (range, 1.6%-18.2%). To wean patients, most respondents used pressure support alone (range, 31.0%-71.7%) or with spontaneous breathing trials (range, 35.7%-68.1%). To conduct spontaneous breathing trials, respondents predominantly used pressure support with positive end-expiratory pressure (range, 56.5%-72.3%) and T-piece (8.9%-59.5%). Across regions, we found important variation in screening frequency, spontaneous breathing trials techniques; ventilator modes, written directives to guide care, noninvasive ventilation; and the roles played by available personnel in various aspects of weaning. CONCLUSIONS: Our findings document the presence and extent of practice variation in ventilator weaning on an international scale, and highlight the multidisciplinary and collaborative nature of weaning.
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Enfermedad Crítica , Intubación Intratraqueal/métodos , Respiración Artificial/métodos , Desconexión del Ventilador/métodos , Adulto , Estudios Transversales , Encuestas de Atención de la Salud , Humanos , Internacionalidad , Respiración Artificial/estadística & datos numéricos , Insuficiencia Respiratoria/terapia , Resultado del Tratamiento , Desconexión del Ventilador/tendenciasRESUMEN
There is no effective chronic suppressive therapy Burkholderia cepacia complex infection in cystic fibrosis (CF) patients. This was a pilot, open-label clinical trial of tobramycin inhalation powder (TIP) delivered via Podhaler twice daily for 28days in adults and children with CF and chronic B. cepacia complex infection in Toronto, Canada. A total of 10 subjects (4 pediatric, 6 adult patients) were treated. There was a mean drop of 1.4 log (CFU/ml) in sputum bacterial density (p=0.01) and sputum IL-8 levels decreased significantly after 28days of TIP (p=0.04). The mean relative change in FEV1 (L) from Day 0 to Day 28 of TIP administration was a 4.6% increase but this was not statistically significant. The majority of patients (70%) had no or mild adverse events.
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Infecciones por Burkholderia , Complejo Burkholderia cepacia , Fibrosis Quística , Infecciones del Sistema Respiratorio , Tobramicina/administración & dosificación , Administración por Inhalación , Adolescente , Adulto , Antibacterianos/administración & dosificación , Infecciones por Burkholderia/diagnóstico , Infecciones por Burkholderia/tratamiento farmacológico , Complejo Burkholderia cepacia/efectos de los fármacos , Complejo Burkholderia cepacia/aislamiento & purificación , Canadá/epidemiología , Niño , Fibrosis Quística/tratamiento farmacológico , Fibrosis Quística/microbiología , Fibrosis Quística/fisiopatología , Monitoreo de Drogas/métodos , Femenino , Volumen Espiratorio Forzado , Humanos , Masculino , Proyectos Piloto , Infecciones del Sistema Respiratorio/diagnóstico , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Infecciones del Sistema Respiratorio/microbiología , Esputo/microbiología , Resultado del TratamientoRESUMEN
RATIONALE: Stakeholder engagement in research is expected to provide unique insights, make research investments more accountable and transparent, and ensure that future research is applicable to patients and family members. OBJECTIVES: To inform the design of a trial of strategies for weaning from mechanical ventilation, we sought to identify preferences of patient visitors regarding outcome and treatment measures. METHODS: We conducted an interviewer-administered questionnaire of visitors of critically ill patients in two family waiting rooms serving three intensive care units (ICUs) in Toronto, Canada. Respondents rated the importance of general and ventilation-related outcomes in two hypothetical scenarios (before a first spontaneous breathing trial, and after a failed spontaneous breathing trial) and selected a preferred technique for the breathing trials. With regard to the patient they were visiting, respondents identified the most important outcome to them at ICU admission, during the ICU stay, and at ICU discharge. MEASUREMENTS AND MAIN RESULTS: We analyzed 322 questionnaires (95.5% response rate). All outcomes were highly rated (average range: 7.82-9.74). Across scenarios, outcomes rated as most important were ICU and hospital survival (9.72, 9.70), avoiding complications (9.45), quality of life (9.394), patient comfort (9.393), and returning to previous living arrangements (9.31). Overall, the most important ventilation-related outcomes were being ventilator-free (8.95), avoiding reintubation (8.905), and passing a spontaneous breathing trial (8.903). Passing a spontaneous breathing trial assumed greater importance after an initial failed attempt. "Time to event" outcomes were less important to visitors. We did not identify a preferred spontaneous breathing trial technique. Although ICU survival was the most important outcome at ICU admission and during the ICU stay, visitors rated quality of life higher than hospital survival at ICU discharge. CONCLUSIONS: Visitors to critically ill patients prioritized two general outcomes (ICU and hospital survival) and three ventilation-related outcomes (being ventilator free, avoiding reintubation, passing a spontaneous breathing trial), and valued avoiding complications, maintaining quality of life, comfort, and returning to previous living arrangements. The outcomes preferences of the survey respondents evolved temporally during the ICU stay.
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Enfermedad Crítica/terapia , Prioridad del Paciente , Calidad de Vida , Participación de los Interesados/psicología , Desconexión del Ventilador/métodos , Visitas a Pacientes/psicología , Adulto , Canadá , Toma de Decisiones , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Proyectos de Investigación , Encuestas y Cuestionarios , Factores de TiempoRESUMEN
Eleven polymorphic microsatellite loci were isolated and developed from the black fly, Simulium negativum, a member of the Simulium arcticum sibling species complex. The observed heterozygosity of the 11 loci ranged from 0.03 to 0.83. The number of alleles per locus ranged from 8 to 19. Significant linkage disequilibria were encountered only for the primer pairs BF7-1 with BF7-5 and BF6-32 with BF7-16. Presumably, these microsatellite loci can be used to study genetic structure within the entire S. arcticum complex.