Critical care medicine
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Critical care medicine · Mar 2003
Comparative StudyHospital mortality rate and length of stay in patients admitted at night to the intensive care unit.
Although admission of patients to a medical ward after 5:00 pm has been associated with increased mortality rate and possibly shorter hospital stay, the association between timing of admission to the intensive care unit and outcome has not been studied. The objective of this study was to determine whether there are any associations between the timing of patient admission to a medical intensive care unit and hospital outcome. ⋯ Nighttime admission to our intensive care unit is not associated with a higher mortality rate or a longer hospital or intensive care unit stay compared with daytime admission.
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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.
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Critical care medicine · Mar 2003
ReviewIs the concept of informed consent applicable to clinical research involving critically ill patients?
Informed consent is a process through which patients or their surrogates authorize medical interventions or involvement in research. The concept of informed consent is supported by ethical principles and legal tradition in the United States. It grew in importance during the 20th century because of documented abuse of research subjects, which led to its codification in federal consent requirements for clinical research. ⋯ For these and other reasons, it has been argued that the concept of informed consent is not applicable to clinical research involving the critically ill and that such consent is not necessary in certain circumstances. Yet, for all its inadequacies, the concept of informed consent and the federal consent requirements should be retained because they promote respect for patients and their right of self-determination and because investigator discretion is not adequate. Stronger research oversight may be as important as informed consent in protecting patient welfare.
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Critical care medicine · Mar 2003
Randomized Controlled Trial Comparative Study Clinical TrialSafety of sedation with ketamine in severe head injury patients: comparison with sufentanil.
The aim of the study was to compare the safety concerning cerebral hemodynamics of ketamine and sufentanil used for sedation of severe head injury patients, both drugs being used in combination with midazolam. ⋯ The results of this study suggest that ketamine in combination with midazolam is comparable with a combination of midazolam-sufentanil in maintaining intracranial pressure and cerebral perfusion pressure of severe head injury patients placed under controlled mechanical ventilation.
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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.