RESUMEN
BACKGROUND: Benefit of early awake prone positioning for COVID-19 patients hospitalised in medical wards and who need oxygen therapy remains to be demonstrated. The question was considered at the time of COVID-19 pandemic to avoid overloading the intensive care units. We aimed to determine whether prone position plus usual care could reduce the rate of non-invasive ventilation (NIV) or intubation or death as compared to usual care alone. METHODS: In this multicentre randomised clinical trial, 268 patients were randomly assigned to awake prone position plus usual care (N = 135) or usual care alone (N = 132). The primary outcome was the proportion of patients who underwent NIV or intubation or died within 28 days. Main secondary outcomes included the rates of NIV, of intubation or death, within 28 days. RESULTS: Median time spent each day in the prone position within 72 h of randomisation was 90 min (IQR 30-133). The proportion of NIV or intubation or death within 28 days was 14.1% (19/135) in the prone position group and 12.9% (17/132) in the usual care group [odds ratio adjusted for stratification (aOR) 0.43; 95% confidence interval (CI) 0.14-1.35]. The probability of intubation, or intubation or death (secondary outcomes) was lower in the prone position group than in the usual care group (aOR 0.11; 95% CI 0.01-0.89 and aOR 0.09; 95% CI 0.01-0.76, respectively) in the whole study population and in the prespecified subgroup of patients with SpO2 ≥ 95% on inclusion (aOR 0.11; 95% CI 0.01-0.90, and aOR 0.09; 95% CI 0.03-0.27, respectively). CONCLUSIONS: Awake prone position plus usual care in COVID-19 patients in medical wards did not decrease the composite outcome of need for NIV or intubation or death. Trial registration ClinicalTrials.gov Identifier: NCT04363463 . Registered 27 April 2020.
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COVID-19 , Ventilación no Invasiva , Insuficiencia Respiratoria , Humanos , COVID-19/terapia , Posición Prona , Pandemias , Respiración Artificial , Insuficiencia Respiratoria/terapiaRESUMEN
BACKGROUND: This prospective study investigated whether taking into account diaphragmatic excursion (DE) measured by ultrasonography would improve the performance of the rapid shallow breathing index (RSBI) to predict extubation success or failure. OBJECTIVES: The aim of the study was to compare the new composite index named the rapid shallow diaphragmatic index (RSDI), and the RSBI measured during a spontaneous breathing trial regarding their ability to predict the need for re-intubation at 72 h. METHODS: One hundred mechanically ventilated patients underwent daily 30-min spontaneous breathing trials (SBTs) under pressure support ventilation of 6 cm H2O and end-expiratory pressure of 0 cm H2O until the SBT was considered successful and followed by extubation. The performances of RSBI (respiratory rate/tidal volume) and of the ratio RSBI/DE measured at 5 and 25 min of the successful SBT were compared in terms of area under the receiver operating characteristics curve (AUC), for predicting extubation success at 72 h. As secondary analysis, extubation and weaning success at 7 d were also considered. As exploratory analyses, predictive indices incorporating both clinical characteristics, the DE, and ultrasound diaphragm thickening fraction (DTF) were investigated. RESULTS: RSBI and RSBI/DE showed AUCs with 95% confidence intervals consistently extending below 0.50, either at the 5th (0.55 [0.36-0.74] and 0.55 [0.34-0.75], respectively) or at the 25th minute of SBT (0.49 [0.27-0.71] and 0.50 [0.29-0.68], respectively) for predicting weaning success at 72 h or at 7 d (5th min: 0.53 [0.37-0.70] and 0.54 [0.37-0.70], respectively; 25th min: 0.54 [0.37-0.71] and 0.55 [0.39-0.71], respectively). An exploratory index incorporating the accessory respiratory muscle activity, DE, DTF, and respiratory rate at 5th min of SBT showed AUCs for predicting extubation success at 7 d in the 78 patients with DTF measurement (0.77 [0.64-0.90]) that were significantly higher than that of the RSBI (P = 0.017) and RSBI/DE (P < 0.001) in the same respective populations. CONCLUSIONS: The RSBI and the ratio RSBI/DE failed to predict weaning success when measured during an SBT performed under minimal pressure support. Predictive indices incorporating ultrasound DE and DTF may merit further investigation.
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Diafragma , Respiración Artificial , Diafragma/diagnóstico por imagen , Humanos , Estudios Prospectivos , Ultrasonografía , Desconexión del VentiladorRESUMEN
BACKGROUND: Few studies have evaluated muscle strength in COVID-19 ICU survivors. We aimed to report the incidence of limb and respiratory muscle weakness in COVID-19 ICU survivors. METHOD: We performed a cross sectional study in two ICU tertiary Hospital Settings. COVID-19 ICU survivors were screened and respiratory and limb muscle strength were measured at the time of extubation. An ICU mobility scale was performed at ICU discharge and walking capacity was self-evaluated by patients 30 days after weaning from mechanical ventilation. RESULTS: Twenty-three patients were included. Sixteen (69%) had limb muscle weakness and 6 (26%) had overlap limb and respiratory muscle weakness. Amount of physiotherapy was not associated with muscle strength. 44% of patients with limb weakness were unable to walk 100 m 30 days after weaning. CONCLUSION: The large majority of COVID-19 ICU survivors developed ICU acquired limb muscle weakness. 44% of patients with limb weakness still had severely limited function one-month post weaning.
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COVID-19/complicaciones , Debilidad Muscular/etiología , Anciano , Brazo/fisiopatología , COVID-19/fisiopatología , Estudios Transversales , Femenino , Estudios de Seguimiento , Francia , Humanos , Pierna/fisiopatología , Pulmón/fisiopatología , Masculino , Persona de Mediana Edad , Debilidad Muscular/fisiopatología , Estudios Retrospectivos , SARS-CoV-2RESUMEN
Importance: Early in-bed cycling and electrical muscle stimulation may improve the benefits of rehabilitation in patients in the intensive care unit (ICU). Objective: To investigate whether early in-bed leg cycling plus electrical stimulation of the quadriceps muscles added to standardized early rehabilitation would result in greater muscle strength at discharge from the ICU. Design, Setting, and Participants: Single-center, randomized clinical trial enrolling critically ill adult patients at 1 ICU within an 1100-bed hospital in France. Enrollment lasted from July 2014 to June 2016 and there was a 6-month follow-up, which ended on November 24, 2016. Interventions: Patients were randomized to early in-bed leg cycling plus electrical stimulation of the quadriceps muscles added to standardized early rehabilitation (n = 159) or standardized early rehabilitation alone (usual care) (n = 155). Main Outcomes and Measures: The primary outcome was muscle strength at discharge from the ICU assessed by physiotherapists blinded to treatment group using the Medical Research Council grading system (score range, 0-60 points; a higher score reflects better muscle strength; minimal clinically important difference of 4 points). Secondary outcomes at ICU discharge included the number of ventilator-free days and ICU Mobility Scale score (range, 0-10; a higher score reflects better walking capability). Functional autonomy and health-related quality of life were assessed at 6 months. Results: Among 314 randomized patients, 312 (mean age, 66 years; women, 36%; receiving mechanical ventilation at study inclusion, 78%) completed the study and were included in the analysis. The median global Medical Research Council score at ICU discharge was 48 (interquartile range [IQR], 29 to 58) in the intervention group and 51 (IQR, 37 to 58) in the usual care group (median difference, -3.0 [95% CI, -7.0 to 2.8]; P = .28). The ICU Mobility Scale score at ICU discharge was 6 (IQR, 3 to 9) in both groups (median difference, 0 [95% CI, -1 to 2]; P = .52). The median number of ventilator-free days at day 28 was 21 (IQR, 6 to 25) in the intervention group and 22 (IQR, 10 to 25) in the usual care group (median difference, 1 [95% CI, -2 to 3]; P = .24). Clinically significant events occurred during mobilization sessions in 7 patients (4.4%) in the intervention group and in 9 patients (5.8%) in the usual care group. There were no significant between-group differences in the outcomes assessed at 6 months. Conclusions and Relevance: In this single-center randomized clinical trial involving patients admitted to the ICU, adding early in-bed leg cycling exercises and electrical stimulation of the quadriceps muscles to a standardized early rehabilitation program did not improve global muscle strength at discharge from the ICU. Trial Registration: ClinicalTrials.gov Identifier: NCT02185989.
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Enfermedad Crítica/rehabilitación , Estimulación Eléctrica , Terapia por Ejercicio , Fuerza Muscular , Adulto , Anciano , Cuidados Críticos , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Músculo Cuádriceps/fisiología , Rehabilitación/métodos , Caminata/fisiologíaRESUMEN
OBJECTIVES: To determine the perceived barriers to the implementation of research findings in clinical practice among critical care nurses and allied health professionals. METHODS: A cross-sectional study was conducted using an online questionnaire sent to critical care nurses and allied health professionals in French-speaking countries. The primary objective was the identification and grading of perceived barriers to implementation of research findings into clinical practice, using a previously validated tool (French version of the BARRIERS scale). The scale is divided into 4 dimensions, each containing 6 to 7 questions to be answered using a 4-point Likert scale (1: no barrier, 4: great barrier). Descriptive statistics were performed and weighted score per dimensions were compared. Univariate and multivariate linear regressions were performed to identify factors associated with the total score by dimension. RESULTS: A total of 994 nurses and allied health professionals (85.1 % of ICU nurses) from 5 countries (71.8 % from France) responded to the survey. Main reported barriers to research findings utilization were "Statistical analyses are not understandable" (54.5 %), "Research articles are not readily available" (54.3 %), and "Implications for practice are not made clear" (54.2 %). Weighted scores differed between dimensions, with the "communication" and "organization" dimensions being the greatest barriers (median [IQR]: 2.3 [1.8-2.7] and 2.0 [1.6-2.4], while the "adopter" and "innovation" dimensions having lower scores (1.5 [1.2-1.8] and 1.5 [1.0-1.8] (all pairwise comparisons p-value < 0.0001, except for the adopter vs. innovation comparison, p > 0.05). CONCLUSIONS: Accessibility and understanding of research results seem to be the main barriers to research utilization in practice by respondents. A large number of the reported barriers could be overcome through education and organizational change. IMPLICATIONS FOR PRACTICE: Promoting a research culture among nurses and allied health professionals is an issue that needs investment. This should include training in critical reading of scientific articles and statistics.
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Investigación en Enfermería , Humanos , Estudios Transversales , Encuestas y Cuestionarios , Proyectos de Investigación , Técnicos Medios en Salud , Actitud del Personal de SaludRESUMEN
BACKGROUND: Because ICU ventilators incorporate flow velocity measurement, cough peak expiratory flow (CPF) can be assessed without disconnecting the patient from the ICU ventilator. Our goal was to estimate the correlation between CPF obtained with the built-in ventilator flow meter (ventilator CPF) and CPF obtained with an electronic portable handheld peak flow meter connected to the endotracheal tube. METHODS: Cooperative mechanically ventilated patients who entered the weaning process and who were ventilated with pressure support < 15 cm H2O and PEEP < 9 cm H2O were eligible for the study. Their CPF measurements obtained on the extubation day were kept for analysis. RESULTS: We analyzed CPF obtained in 61 subjects. The mean ± SD value of ventilator CPF and peak flow meter CPF were 72.6 ± 27.5 L/min and 31.1 ± 13.4 L/min. The Pearson correlation coefficient was 0.63 (95% CI 0.45-0.76), P < .001. The ventilator CPF had an area under the receiver operating characteristic curve of 0.84 (95% CI 0.75-0.93) to predict a peak flow meter CPF < 35 L/min. Neither ventilator CPF nor peak flow meter CPF differed significantly between subjects who were or were not re-intubated within 72 h (n = 5) and failed to predict re-intubation at 72 h (area under the receiver operating characteristic curve of 0.64 [95% CI 0.46-0.82] and 0.47 [95% CI 0.22-0.74]). CONCLUSIONS: CPF measurements using a built-in ventilator flow meter were feasible in routine practice with cooperative ICU subjects who were intubated and correlated with CPF assessed by an electronic portable peak flow meter.
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Tos , Respiración Artificial , Humanos , Ventiladores Mecánicos , Intubación Intratraqueal , Unidades de Cuidados Intensivos , Desconexión del VentiladorRESUMEN
INTRODUCTION: COVID-19 is responsible of severe hypoxaemia and acute respiratory distress syndrome (ARDS). Prone positioning improves oxygenation and survival in sedated mechanically patients with ARDS not related to COVID-19. Awake prone positioning is a simple and safe technique which improves oxygenation in non-intubated COVID-19 patients. We hypothesised that early prone positioning in COVID-19 patients breathing spontaneously in medical wards could decrease the rates of intubation or need for noninvasive ventilation or death. METHODS AND ANALYSIS: PROVID-19 is an investigator-initiated, prospective, multicentre randomised, controlled, superiority trial comparing awake prone positioning to standard of care in hypoxaemic COVID-19 patients in 20 medical wards in France and Monaco. Patients are randomised to receive either awake prone position plus usual care or usual care alone with stratification on centres, body mass index and severity of hypoxaemia.The study objective is to compare the rate of treatment failure defined as a composite endpoint comprising the need for non-invasive ventilation (at two pressure levels) or for intubation or death, between the intervention group (awake prone position plus usual care) and the usual care (usual care alone) group at 28 days. ETHICS AND DISSEMINATION: The protocol and amendments have been approved by the ethics committees (Comité de protection des personnes Ouest VI, France, no 1279 HPS2 and Comité Consultatif d'Ethique en matière de Recherche Biomédicale, Monaco, no 2020.8894 AP/jv), and patients are included after written informed consent. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04363463.