Were There "Additional Foreseeable Risks" in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials.

Even though the interventions were adapted from standard clinical practice, the way they were provided meant that the care given infants in the study was distinctly different from standard care, with different risk profiles. Parents should have been informed about those differences.

SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies.

The design of SUPPORT has been widely misunderstood. This confusion has driven much of the debate about the trial - and threatens the whole enterpise of comparative effectiveness research.

[Non invasive ventilation in the ICU for the neuromuscular patient: ethical issues]. / Ventilation non invasive et insuffisance respiratoire chronique d'origine neuromusculaire: implications pour l'intensiviste. Aspects ethiques.

Non-invasive mechanical ventilation in patients with chronic neuromuscular disorders is an effective tool for treating dyspnea or sleep disturbances often observed in such patients. So, NIV has to be considered as a palliative treatment and it must systematically be offered to these patients. Mechanical ventilation, non-invasive or invasive (via a trachesotomy) have to be considered systematically with patients and families at an earlier stages of these diseases in order to design a strategy in case of acute respiratory failure. In a second parent paper of this issue, we discuss the medico-legal implications of mechanical ventilation in neuromuscular failure, particularly the end-of-life aspects.

[Non invasive ventilation in the ICU for the neuromuscular patient: legal issues]. / Ventilation non invasive et insuffisance respiratoire chronique d'origine neuromusculaire: implications pour l'intensiviste. Aspects médico-légaux.

The legal frame in which chronic mechanical ventilation is placed in Switzerland and France is discussed in this article. Safety of the patients and responsibility of caregivers are considered. We also discuss the ethical and legal aspects of the end-of-life of these patients, particularly when they decide that mechanical ventilation must be interrupted because they do not more tolerate their poor quality of life, and when they deliberately decide to die.

Should noninvasive ventilation be used with the do-not-intubate patient?

Most of the large quantity of data on noninvasive ventilation (NIV) in acute respiratory failure is from patients who want all possible treatments and life-support. Few data are available on NIV in patients who have elected specific limits on life support and treatments (eg, patients with do-not-intubate [DNI] orders) and patients who are near the end of life and will receive comfort measures only (CMO). The most critical issue regarding NIV in DNI and CMO patients is informed consent. The patient must be informed of the risks and potential benefits of NIV, and must consent to NIV. We have few data on patients' attitudes about NIV at end of life. Data from cancer patients at end of life suggest that they want to maintain control over care decisions and may want treatment that delays death long enough that they can put their affairs in order. If informed consent and control of care decisions are assured, then NIV can be appropriate in DNI and CMO patients to reverse an acute respiratory failure that is not necessarily life-terminating, or to improve patient comfort, or to delay death.

Clinical practice guideline for the use of noninvasive positive pressure ventilation in COPD patients with acute respiratory failure.

Noninvasive positive pressure ventilation has been demonstrated to be of benefit in preventing endotracheal intubation and reducing mortality in specific patients in the setting of acute exacerbations of chronic obstructive pulmonary disease. The successful application of noninvasive positive pressure ventilation depends on a multitude of factors, including patient selection, choice of interface, physician experience, and patient-ventilator synchrony. The use of clinical practice guidelines has been shown to improve the process and outcomes of care. This paper presents a guideline for the use of noninvasive positive pressure ventilation in the setting of acute ventilatory failure in patients with acute exacerbations of chronic obstructive pulmonary disease.

Lessons from the ARDS network ventilator trial design controversy.

This article reviews the available published literature on the ARDSnet and summarizes the debate that occurred over the major ARDSnet trials. It discusses the challenges its organizers, supporters, and detractors faced. It reviews how uncertainty in research evolves and how it affects large trials of national or international scope. It also considers how the outcome of a scientific disagreement is shaped by the science and by how the debate is framed. The authors hope to illustrate some of the obstacles to performing outcome studies and clinical trials involving critically ill patients with complex syndromes that currently lack effective treatments.

Management guidelines for motor neurone disease patients on non-invasive ventilation at home.

Most motor neurone disease (MND) patients die of respiratory system complications. When patients have advanced disease with symptoms of respiratory failure, management issues can become complicated by the introduction of assisted ventilatory devices. Therefore, care provision by a multidisciplinary team must be structured and co-ordinated in order to ensure that patients and their carers receive the optimal level of care. The objective of this article is to review the literature and explore the complex issues surrounding the use of non-invasive positive pressure ventilation (NIPPV) in home care MND patients as a justification for the development of a management guideline for medical practitioners. A guideline for multidisciplinary care of home ventilated MND patients will be proposed.

ALS patients on TPPV: totally locked-in state, neurologic findings and ethical implications.

Seventy patients with ALS using tracheostomy positive pressure ventilation (TPPV) were evaluated for impaired communication. Severely impaired communication is divided into the totally locked-in state (TLS) and the minimal communication state (MCS). TLS occurred in 8 of 70 (11.4%). In the 33 patients on TPPV for more than 5 years, TLS developed in 6 (18.2%) and MCS in 11 (33.1%). Respiratory management for ALS allows long-term survival if mechanical ventilation is used.

Aspectos éticos de la ventilación mecánica domiciliaria / Ethical issues of home mechanical ventilation

La mortalidad infantil ha disminuido gracias a los cuidados intensivos neonatales y pediátricos, esto a su vez ha contribuido a la sobrevida de niños con secuelas graves y dependencias tecnológicas especiales. La ventilación mecánica se utiliza como medida de soporte vital, en un intento de mejorar constantes biológicas y la calidad de vida del paciente y su entorno familiar; sin embargo, no siempre se obtiene el resultado esperado y las cargas sicológicas, sociales y financieras constituyen procesos que requieren desarrollar evaluaciones en el dominio de la bioética. Los desafíos y dilemas clínicos al instaurar ventilación no invasiva (VNI) se diferencian según las patologías y sus pronósticos. La asistencia ventilatoria no invasiva (AVNI), en algunos pacientes, logrará una disminución franca del esfuerzo respiratorio consiguiendo mejorar el crecimiento y desarrollo del sistema pulmonar, permitiendo luego de un tiempo su suspensión o mantenerla en forma crónica estable. En otras situaciones con deterioro progresivo y/o otras co-morbilidades, desde la dimensión bioética puede ser controversial, el inicio, mantención y transición hacia estrategias de mayor complejidad. En este documento se revisan los aspectos éticos que deben ser considerados en la toma de decisión de brindar AVNI en niños con enfermedades crónicas, en la perspectiva de los nuevos desafíos terapéuticos posibles con tecnología aplicada.