Current opinion in critical care
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Curr Opin Crit Care · Dec 2004
ReviewInformed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive.
The new European legislation on good clinical practice in the conduct of clinical trials on drugs has raised serious concern that potentially lifesaving studies cannot be carried out in critically ill patients in Europe anymore after May 2004. The requirement of nominating a legal representative for obtaining informed consent before inclusion will deprive current and future patients of participation in research. The new legislation does not differentiate between patients who are incompetent because of a psychiatric illness or dementia and patients who are incapacitated owing to an emergency situation. All those patients may be enrolled in a clinical trial only after informed consent has been granted by a legal representative. ⋯ Many groundbreaking therapies will not be scientifically evaluated anymore, and thus beneficial treatments in fatal diseases will be prevented. The European legislation is asked to adapt the Directive to promote research in critically ill patients.
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Curr Opin Crit Care · Dec 2004
ReviewVentilator strategies for posttraumatic acute respiratory distress syndrome: airway pressure release ventilation and the role of spontaneous breathing in critically ill patients.
Patients who experience severe trauma are at increased risk for the development of acute lung injury and acute respiratory distress syndrome. The management strategies used to treat respiratory failure in this patient population should be comprehensive. Current trends in the management of acute lung injury and acute respiratory distress syndrome consist of maintaining acceptable gas exchange while limiting ventilator-associated lung injury. ⋯ Airway pressure release ventilation is a mode of mechanical ventilation that maintains lung volume to limit intra tidal recruitment /derecruitment and improves gas exchange while limiting over distension. Clinical and experimental data demonstrate improvements in arterial oxygenation, ventilation-perfusion matching (less shunt and dead space ventilation), cardiac output, oxygen delivery, and lower airway pressures during airway pressure release ventilation. Mechanical ventilation with airway pressure release ventilation permits spontaneous breathing throughout the entire respiratory cycle, improves patient comfort, reduces the use of sedation, and may reduce ventilator days.
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Curr Opin Crit Care · Dec 2004
ReviewThe acute respiratory distress syndrome network controversy: lessons and legacy.
Several of the Acute Respiratory Disease Syndrome Network clinical trials embrace a clinical trial design that evaluates contrasting strategies, one or both of which represents only a segment of standard practices. Such a trial design has engendered ethical controversy regarding the value of such trials and their ability to protect human subjects. During the past year, commentators have continued to reflect on the significance of such trials. ⋯ The controversy related to and the impact of the Acute Respiratory Disease Syndrome Network clinical trial design on clinical practice offer an opportunity to explore the trade-offs between explanatory and pragmatic types of clinical trials. Such discussions will lead to a clearer understanding of the value of both types of clinical trials and the optimal ethical conduct of such trials.
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Despite advances in the care of the injured, the morbidity and mortality of traumatic hemorrhage remain a significant problem. Traumatologists continue to look for ways to treat bleeding and prevent the sequelae of hemorrhagic shock. Recombinant factor VIIa, developed for the treatment of patients with hemophilia, has been used with some success in acute bleeding associated with injuries. ⋯ Although case experience is encouraging, no level 1 evidence has been published that demonstrates clinical or economic benefit of the use of recombinant factor VIIa in trauma patients. Many questions remain to be answered, ideally through randomized, prospective clinical trials. In particular, the issues of patient selection, ideal dosing, and factors associated with futile administration need to be elucidated.
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Curr Opin Crit Care · Dec 2004
ReviewPatient care versus research: does clinical research provide individual benefit to patients enrolled in trials?
Historically, clinical research and patient care have long been intertwined. Until the mid-1970s, physicians in both North America and Europe considered that research on their patients was an integral part of the care that they delivered to them. In the United States, it was after the recommendations of the Belmont report, in 1979, that both medical activities were clearly separated. But, in Europe, the concept of "individual direct benefit from research" is still prevailing in some national legislation. ⋯ The European directive on clinical research, voted on in 2001 and still in the process of being implemented in national laws of the European Union Member States, mandates clarification of these issues. All European investigators are concerned because the framework of regulations governing clinical research will be markedly altered. The replacement of the distinction between research with and without direct benefit by the evaluation of the risk/benefit ratio by ethics committees is one of the most important changes that is due to happen soon.