Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial.

BACKGROUND: It is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation-related complications. DESIGN AND METHODS: The PRONELIFE study is an investigator-initiated, international, multicenter, randomized clinical trial in patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Consecutive patients admitted to participating ICUs are randomly assigned to standard care with awake prone positioning, versus standard care without awake prone positioning. The primary endpoint is a composite of tracheal intubation and all-cause mortality in the first 14 days after enrolment. Secondary endpoints include time to tracheal intubation and effects of awake prone positioning on oxygenation parameters, dyspnea sensation, and complications. Other endpoints are the number of days free from ventilation and alive at 28 days, total duration of use of noninvasive respiratory support, total duration of invasive ventilation, length of stay in ICU and hospital, and mortality in ICU and hospital, and at 28, 60, and 90 days. We will also collect data regarding the tolerance of prone positioning. DISCUSSION: The PRONELIFE study is among the first randomized clinical trials investigating the effect of awake prone positioning on intubation rate in ICU patients with acute hypoxemic failure from any cause. The PRONELIFE study is sufficiently sized to determine the effect of awake prone positioning on intubation for invasive ventilation-patients are eligible in case of acute hypoxemic respiratory failure without restrictions regarding etiology. The PRONELIFE study is a pragmatic trial in which blinding is impossible-however, as around 35 ICUs worldwide will participate in this study, its findings will be highly generalizable. The findings of the PRONELIFE study have the potential to change clinical management of patients who may need invasive ventilation because of acute hypoxemic respiratory failure. TRIAL REGISTRATION: ISRCTN ISRCTN11536318 . Registered on 17 September 2021. The PRONELIFE study is registered at clinicaltrials.gov with reference number NCT04142736 (October, 2019).

Limitación del esfuerzo terapéutico en Cuidados Intensivos. ¿Ha cambiado en el siglo XXI? / Limitation of therapeutic effort in Intensive Care: has it changed in the XXI century?

Fundamento. La limitación del esfuerzo terapéutico (LET) es la decisión meditada sobre la no implementación o la retirada de terapéuticas médicas al anticipar que no conllevarán un beneficio significativo al paciente. Objetivo. Conocer la frecuencia con que se decide la LET en la práctica diaria, y si ha cambiado al inicio del siglo xxi. Pacientes y métodos. Durante el año 2003 incluimos en el informe de alta de cada paciente del Área de Críticos una pregunta de obligada respuesta sobre si hubo o no LET. Se registró la mortalidad en el Área de Críticos y la mortalidad hospitalaria. Resultados. Durante el período de estudio ingresaron en el Área de Críticos 1.510 pacientes, con una edad de 61 ± 17 años. La LET se reconoció explícitamente en una minoría de pacientes (10%) y se asoció a una alta mortalidad hospitalaria (88%). En el 55% de los pacientes que fallecieron en el Área de Críticos hubo algún tipo de LET. Los pacientes con LET tuvieron mayor riesgo de muerte predicho por APACHE II (37 ± 27 frente a 22 ± 22), mayor frecuencia de enfermedades crónicas previas (26% frente a 10%), mayor edad (72 ± 12 frente a 60 ± 18 años) y mayor estancia en el Área de Críticos (10 ± 14 frente a 6 ± 8 días). Describimos un nuevo grupo de pacientes (1% del total) que ingresan en Críticos ya con alguna LET. Conclusión. En el día a día, aunque aún escasa, la LET está aumentando y se asocia a una muy mala evolución. Se decide más frecuentemente en pacientes mayores y con co-morbilidades

Background. The limitation of therapeutic effort (LTE) is the meditated decision on the non-implementation or withdrawal of therapeutic measures due to anticipating that they would not entail a significant benefit for the patient. Objective. Know the frequency with which LTE is decided in the daily practice and if it has changed at the onset of the xxi century. Patients and methods. During the year 2003, we included a question with required response on whether or not there was a LTE in the discharge report of each patient of the Critical Area. Mortality in the Critical area and hospital mortality were recorded. Results. During the study period, 1,510 patients, aged 61 ± 17 years, were admitted to the Critical Area. LTE was explicitly admitted in a minority of patients (10%) and was associated to high hospital mortality (88%). In 55% of the patients who died in the Critical area, there was some type of LTE. Patients with LTE had greater risk of death predicted by the APACHE II (37 ± 27 versus 22 ± 22), greater frequency of previous chronic diseases (26% versus 10%), older age (72 ± 12 versus 60 ±18 years) and longer stay in the Critical Area (10 ± 14 versus 6 ± 8 days). We discovered a new group of patients (1% of the total) who were admitted in the Critical Area with some LTE. Conclusion. Although still scarce, LTE is increasing and is associated to very poor course in everyday work. It is decided more frequently in older patients with comorbidities

Las unidades de cuidados intensivos y la atención integral del enfermo crítico / Intensive care units and integral care of the critically-ill patients

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[Mortality and hospital stay adjusted for severity as indicators of effectiveness and efficiency of the care provided to critically ill patients. European and North American Study of Severity Systems]. / Mortalidad y estancia hospitalaria ajustadas por gravedad como indicadores de efectividad y eficiencia de la atención a pacientes en estado crítico. European and North American Study of Severity Systems.

BACKGROUND: Hospital mortality and length of stay, both adjusted for severity of illness, have been used as indicators of effectiveness and efficiency of health care in critical patients. PATIENTS AND METHODS: 1,270 adult critical patients, consecutively admitted in 17 intensive care units (ICU) from Catalonia and the Balearic Islands, Spain, have been included. For each hospital, effectiveness has been assessed with a quality performance index (QOI) obtained by dividing the number of observed deaths by the number of deaths expected according to the MPM system (MPM II0). Efficiency has been assessed with a resource utilization index (RUI) obtained by dividing the number of observed weighted hospital days (WHD) by the number of expected WHD. WHD is a measure of resource use which weights ICU days more heavily than non-ICU days. Expected WHD have been obtained by a regression model including severity of illness and the presence/absence of surgery. RESULTS: Ten of the 17 hospitals life within one standard deviation of the mean on both clinical and economical indices. There are 3 hospitals with optimal values on both indices. There is no evidence of association between effectiveness and resource utilization. CONCLUSIONS: Clinical and economical performance of hospitals can be quantified with simple indicators which allow to compare centers. Hospitals can be effective and efficient at the same time.

[Use of mortality probability models (MPM II) in the evaluation of the effectiveness of care of critically ill patients. European and North American Study of Severity Systems]. / Utilización de los modelos probabilísticos de mortalidad (MPM II) para evaluar la efectividad de la atención a pacientes en estado crítico. European and North American Study of Severity Systems.

BACKGROUND: The performance of the Mortality Probability Models (MPM II) has been assessed in Intensive Care Units (ICUs) in Catalonia and the Balearic Islands. The MPM II system has been customized to that geographic area and quality performance has been evaluated in each ICU. METHODS: 1,270 adult critical patients, consecutively admitted in 16 ICUs from Catalonia and 1 from the Balearic Islands have been included. Probability of dying in the hospital has been calculated at admission in the ICU and at 24 hours using the models MPM II0 and MPM II24. Goodness-of-fit of the MPM II system in the overall group of 17 ICUs has been analyzed. Logistic regression has been used to customize the MPM II system to all the ICUs together. A Quality Performance Index (QPI) for each ICU has been obtained by dividing the number of the observed deaths by the number of deaths expected by the MPM II system. RESULTS: The overall QPI was 1.15 when using the MPM II0 and 1.17 when using the MPM II24. The QPI in the 17 ICUs ranged from 0.58 to 2.05. Three ICUs showed excess of mortality and 2 ICUs had less deaths than expected. The process of customization of MPM II to the 17 ICUs as a group improved the estimation of expected mortality. CONCLUSIONS: The use of severity indexes allows to compare the outcome of patients in the ICU and provides an indicator of quality of care. The excess of mortality observed in some ICU should produce a watchful follow-up of outcome. Risk factors for excess of mortality should be studied.