Critical care medicine
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Critical care medicine · Mar 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialEfficacy and safety of LY315920Na/S-5920, a selective inhibitor of 14-kDa group IIA secretory phospholipase A2, in patients with suspected sepsis and organ failure.
Concentrations of group IIA secretory phospholipase A, an inflammatory response mediator, are increased in the plasma of patients with sepsis and septic shock, and the extent of elevation is correlated with mortality. LY315920Na/S-5920 is a selective inhibitor of group IIA secretory phospholipase A that has been shown to inhibit serum group IIA secretory phospholipase A enzyme activity in patients with severe sepsis. The primary objectives of this study were to determine whether there was a dose-response relationship between two doses of LY315920Na/S-5920 compared with placebo in the reduction of 28-day all-cause mortality in patients with severe sepsis and to determine whether LY315920Na/S-5920 had an acceptable safety profile.(2) (2) (2) ⋯ Administration of LY315920Na/S-5920 had an acceptable safety profile in patients with severe sepsis. There was no overall survival benefit associated with the use of LY315920Na/S-5920 in this study. However, prospectively planned secondary analyses suggested that treatment with LY315920Na/S-5920 was associated with an improvement in survival in patients treated within 18 hrs of the first sepsis-induced organ failure.
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Critical care medicine · Mar 2003
Randomized Controlled Trial Comparative Study Clinical TrialHeat and moisture exchangers in mechanically ventilated intensive care unit patients: a plea for an independent assessment of their performance.
To determine whether use of a hygroscopic and hydrophobic heat and moisture exchanger (HME) for 7 days without change affects its efficiency in long-term, mechanically ventilated, chronic obstructive pulmonary disease (COPD) patients. ⋯ Manufacturer specifications and bedside measurements of absolute humidity differed considerably for the Hygroster, which in certain instances did not achieve efficient humidification in both COPD and non-COPD patients. This did not occur with the Hygrobac, which performed well throughout the 7-day period in both COPD and non-COPD patients. Our results speak for independent and evaluation of HMEs.
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Critical care medicine · Mar 2003
Randomized Controlled Trial Comparative Study Clinical TrialComparison of different airway management strategies to ventilate apneic, nonpreoxygenated patients.
Endotracheal intubation is the gold standard for providing emergency ventilation, but acquiring and maintaining intubation skills may be difficult. Recent reports indicate that even in urban emergency medical services with a high call volume, esophageal intubations were observed, requiring either perfect intubation skills or development of alternatives for emergency ventilation. ⋯ Paramedics were able to employ the laryngeal mask airway, Combitube, and cuffed oropharyngeal airway in apneic patients with normal lung compliance and airways. In this population, bag-valve-mask ventilation was the most simple and successful strategy. Small tidal volumes applied with a pediatric self-inflating bag and 100% oxygen resulted in adequate oxygenation and ventilation.
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Critical care medicine · Mar 2003
Randomized Controlled Trial Comparative Study Clinical TrialLong-term mechanical ventilation with hygroscopic heat and moisture exchangers used for 48 hours: a prospective clinical, hygrometric, and bacteriologic study.
To determine whether use of a hygroscopic heat and moisture exchanger (HME) for 48 hrs without change affects its efficiency and the level of bacterial colonization in long-term mechanically ventilated medical intensive care unit patients. ⋯ These two purely hygroscopic HMEs provided safe and efficient humidification during a 48-hr period of use in long-term mechanically ventilated medical intensive care unit patients, including chronic obstructive pulmonary disease patients. In addition, they maintained ventilatory circuits clean, despite the absence of filtering media. The cost of mechanical ventilation is consequently reduced.
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Critical care medicine · Mar 2003
ReviewEthical framework for the use of sham procedures in clinical trials.
Ethical, professional, and financial considerations support the highest standards in demonstrating the safety and efficacy of new clinical interventions. Professional and regulatory mechanisms implemented to ensure that medical agents undergo a thorough process of systematic testing are lacking in the case of medical procedures. ⋯ We examine the major ethical objections to placebo-controlled procedure trials, including those involving sham surgery, and provide an ethical framework for assessing whether a placebo procedure is ethical to administer in the context of a clinical trial. A placebo-controlled trial of an invasive procedure can be ethically justified if: 1) there is a valuable, clinically relevant question to be answered by the research, 2) the placebo control is methodologically necessary to test the study hypothesis, 3) the risk of the placebo control itself has been minimized, 4) the risk of a placebo control does not exceed a threshold of acceptable research risk, 5) the risk of the placebo control is justified by valuable knowledge to be gained, and 6) the misleading involved in the administration of a placebo control is adequately disclosed and authorized during the informed consent process.