Crit Care Resusc
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Randomized Controlled Trial Multicenter Study Comparative Study
Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure (PHARLAP): a protocol for a phase 2 trial in patients with acute respiratory distress syndrome.
Mechanical ventilation is a life-saving intervention that maintains gas exchange in patients with acute respiratory distress syndrome (ARDS); however, it is associated with high mortality and it may augment, or even initiate, lung injury. An open lung ventilation strategy that combines alveolar recruitment manoeuvres with individually titrated positive end-expiratory pressure (PEEP) and targeting lower tidal volumes, or driving pressures by a permissive approach to hypercapnia, may reduce the lung injury associated with mechanical ventilation. This protocol reports the rationale, study design and analysis plan of the Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure (PHARLAP) trial. ⋯ The PHARLAP trial will determine whether the intervention strategy is effective in increasing ventilator-free days in patients with ARDS. If the PHARLAP strategy is proven to improve ventilator-free days, it will provide a strong impetus to conduct an international phase 3 trial to determine the effects of this strategy on mortality.
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Mortality related to sepsis among critically ill patients remains high. Recent literature suggests that hypercapnia may affect the pathophysiology of sepsis. The effects of hypercapnia on sepsis are largely related to the direct effect of hypercapnic acidosis on immune function and, as a consequence, of increased cardiac output that subsequently leads to improved tissue oxygenation. ⋯ It appears from these very limited clinical data that hypercapnia may be associated with adverse outcomes. There are no clinical studies investigating clinical outcomes of hypercapnic acidosis or compensated hypercapnia in sepsis and septic shock in critical care settings, thus extrapolation of the experimental results to guide critical care practice is difficult. Clinical studies are needed, especially in critically ill patients, to define the effects of compensated hypercapnia and hypercapnic acidosis that may aid clinicians to improve the outcomes in sepsis.
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The cluster randomised crossover (CRXO) design provides an opportunity to conduct randomised controlled trials to evaluate low risk interventions in the intensive care setting. Our aim is to provide a tutorial on how to perform a sample size calculation for a CRXO trial, focusing on the meaning of the elements required for the calculations, with application to intensive care trials. ⋯ The CRXO design enables the evaluation of routinely used interventions that can bring about small, but important, improvements in patient care in the intensive care setting.
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Fluid bolus therapy (FBT) is a widely used intervention in paediatric critical illness. The aim of this study was to describe the attitudes and practices towards FBT of paediatric intensive care doctors in Australia and New Zealand. ⋯ Paediatric intensive care doctors prefer 0.9% saline and 4% albumin for FBT. Heart rate and blood pressure are the most preferred markers to assess fluid responsiveness. Preferences for FBT in specific conditions exist.