Observations of withdrawal of life-sustaining treatment from patients who became non-heart-beating organ donors.

OBJECTIVE: Non-heart-beating organ donation for transplantation is increasing despite the concern whether all the donors are dead. This concern is based on the adequacy of documentation of death and the appropriate duration that circulation and respiration should be absent before death certification. No studies have examined the documentation and deaths of patients who became non-heart-beating organ donors. DESIGN: Retrospective study of observational data. PATIENTS: All non-brain-dead patients who became non-heart-beating organ donors at the University of Pittsburgh Medical Center from January 1, 1993, to June 30, 1998, were identified. Records for 15 of 16 patients were available for review. MEASUREMENTS AND MAIN RESULTS: Adequacy of documentation, extubation time, onset of severe hypotension, duration of absent circulation before death was certified, and the time of incision for organ procurement were ascertained. Twelve of 15 records had all required clinical documentation. The mean age of patients was 46.5 +/- 5.7 yrs. All 15 patients were extubated before death and had femoral arterial catheters; one had a biventricular assist device discontinued. The time of hypotension and pulselessness was not documented for one and three patients, respectively. All 12 patients with documentation had > or =2 mins of absent circulation. Time from certification to incision for procurement was 1.1 +/- 2.3 mins. CONCLUSIONS: In a small study of non-heart-beating organ donation, circulation never resumed after >1 min of absent circulation, suggesting that 2 mins of absent circulation is sufficient to certify death. Three of 15 patients had inadequate documentation. Gaps and inconsistencies in documentation may raise concern about the potential for abuse.

Acute care nurse practitioner curriculum: content and development process.

Curriculum development for preparation of acute care nurse practitioners requires a comprehensive process. To develop a program for their preparation at a large university, the faculty examined needs of the target patient population and care delivery system; scope of acute care nurse practitioner practice; current guidelines for the education of primary care nurse practitioners; evolving guidelines for the didactic and clinical education of acute care nurse practitioners; educational requirements of governing or licensing and certifying bodies; and placement of this new role within the existing healthcare team structure. A curriculum was then developed using a collaborative, multidisciplinary approach.

Trial of nurse practitioners in intensive care.

As public concern for quality control of medical care at the beginning of this century forced regulations on medical licensing of physicians, the forces of change in health care are again substantial, this time driven by concerns for cost and access. Our experience at the University of Pittsburgh Medical Center leads us to believe that well-trained physician extenders will play a valuable role in improving efficiency and effectiveness in the care of critically ill patients. We have developed a method for training and supervision. Graded practice supervision, with physician-led professional review, is considered a reasonable goal. We propose that the appropriate degree of supervision in any given area can be determined by: a) careful development of training programs; b) careful assessment of the individual's practice with the target patient population; and c) application of a review process that is sensitive in that population. Issues surrounding the independent practice and reimbursement of acute care nurse practitioners (ACNPs) are not resolved. These issues should be addressed by joint position statements that are based on objective documentation of the safe, effective performance of ACNPs, and on the incorporation of routine performance measurements with continued medical or joint evaluation of the quality review system. Guidelines regarding the evolving roles of ACNPs should be established by professional associations and state or national boards of both nursing and medical practice. Critical care physician and nursing leaders should lead such initiatives.

Outcome from central nervous system injury.

In general, coma portends a very poor outcome in ICU patients except when a drug overdose is the cause. Interactions with concurrent diseases and the cause of the comatose state are important variables that modify mortality rates. Recent studies have made it possible to predict irreversibility with a high degree of specificity in many cases. Three approaches show promise for early prediction of poor outcome--multivariate analysis, neurologic findings, and technologic innovations. Multivariate analysis of combinations of clinical conditions common in ICUs appears to have defined some patients whose prognosis is nearly hopeless, empirically. It would seem reasonable to consider withholding or withdrawing life support from these patients so that mere prolongation of death is avoided. Additional studies are needed and are relatively easy to perform with computerized statistical analyses of a readily available database derived from large patient populations in multicenter studies. A second useful approach for predicting irreversibility has arisen from studies using neurologic findings at defined time points after brain injury. The studies of Levy and colleagues exemplify this approach; their data suggest that coma can be declared irreversible with a high degree of confidence in a large subset of patients, delineated by simple sequential neurologic observations. Finally, technologies are evolving that may lead to noninvasive measurements to provide quantitative evidence of irreversible brain damage. Additional clinical studies are needed to validate the predictive value of these approaches to identifying patients who are certain to have a poor ultimate outcome. It then may be possible to predict function and irreversibility of central nervous system injury in individual cases with a high degree of certainty early in the clinical course.

Procuring organs from a non-heart-beating cadaver: a case report.

Organ transplantation is an accepted therapy for major organ failure, but it depends on the availability of viable organs. Most organs transplanted in the U.S. come from either "brain-dead" or living related donors. Recently organ procurement from patients pronounced dead using cardiopulmonary criteria, so-called "non-heart-beating cadaver donors" (NHBCDs), has been reconsidered. In May 1992, the University of Pittsburgh Medical Center (UPMC) enacted a new, complicated policy for procuring organs from NHBCDs after the elective removal of life support. Seventeen months later only one patient has become a NHBCD. This article describes her case and the results of interviews with the health care team and the patient's family. The case and interviews are discussed in relation to several of the ethical concerns previously raised about the policy, including potential conflicts of interest, the definition of cardiopulmonary death, and a possible net decrease in organ donation. The conclusion is reached that organ procurement from non-heart-beating cadavers is feasible and may be desirable both for the patient's family and the health care providers.

History of organ donation by patients with cardiac death.

When successful solid organ transplantation was initiated almost 40 years ago, its current success rate was not anticipated. But continuous efforts were undertaken to overcome the two major obstacles to success: injury caused by interrupting nutrient supply to the organ and rejection of the implanted organ by normal host defense mechanisms. Solutions have resulted from technologic medical advances, but also from using organs from different sources. Each potential solution has raised ethical concerns and has variably resulted in societal acclaim, censure, and apathy. Transplant surgery is now well accepted, and the list of transplant candidates has grown far quicker than the availability of organs. More than 30,000 patients were awaiting organs for transplantation at the end of March 1993. While most organs came from donors declared dead by brain criteria, the increasing shortage of donated organs has prompted a reexamination of prior restrictions of donor groups. Recently, organ procurement from donors with cardiac death has been reintroduced in the United States. This practice has been mostly abandoned by the U.S. and some, though not all, other countries. Transplantation has been more successful using organs procured from heart-beating, "brain dead" cadavers than organs from non-heart-beating cadavers. However, recent advances have led to success rates with organs from non-heart-beating donors that may portend large increases in organ donation and procurement from this source.

Development of the University of Pittsburgh Medical Center policy for the care of terminally ill patients who may become organ donors after death following the removal of life support.

In the mid 1980s it was apparent that the need for organ donors exceeded those willing to donate. Some University of Pittsburgh Medical Center (UPMC) physicians initiated discussion of possible new organ donor categories including individuals pronounced dead by traditional cardiac criteria. However, they reached no conclusion and dropped the discussion. In the late 1980s and the early 1990s, four cases arose in which dying patients or their families requested organ donation following the elective removal of mechanical ventilation. Controversy surrounding these cases precipitated open discussion of the use of organ donors pronounced dead on the basis of cardiac criteria. Prolonged deliberations by many committees in the absence of precedent ultimately resulted in what is, to our knowledge, the country's first policy for organ donation following elective removal of life support. The policy is intricate and conservative. Care was taken to include as many interested parties as possible in an effort to achieve representative and broad based support. This paper describes the development of the UPMC policy on non-heart-beating organ donation.

Pulse oximetry in the postoperative care of cardiac surgical patients. A randomized controlled trail.

STUDY OBJECTIVE: To demonstrate the utility of pulse oximetry in detecting clinically unapparent episodes of arterial desaturation in postoperative cardiac surgical patients and to evaluate the effect of pulse oximetry on ordering arterial blood gas analyses. DESIGN: Prospective, randomized, partially blinded comparison. SETTING: Cardiothoracic surgical intensive care unit. PATIENTS: 35 patients following elective cardiac surgical procedures. INTERVENTIONS: All patients were monitored continuously with pulse oximetry throughout their ICU course. In group 1 patients, the SpO2 data were available at the bedside. In group 2 patients, the SpO2 data were masked at the bedside and monitored at a remote location. MEASUREMENTS AND RESULTS: Utilization of pulse oximetry allowed a significant reduction in arterial blood gas utilization in group 1 (group 1: 12.4 +/- 7.5 blood gas analyses per ICU admission vs group 2: 23.1 +/- 8.8; p = 0.0007) without adverse events. Clinically unapparent desaturations were detected in 7 of 15 patients in group 2. CONCLUSIONS: Pulse oximetry improves patient safety through the detection of clinically unapparent episodes of desaturation and can allow a reduction in the number of blood gas analyses utilized without adverse effects to the patient. This may allow a potential cost savings to the patient.

Risk monitoring of randomized trials in emergency medicine: experience of the Brain Resuscitation Clinical Trial II.

Risk monitoring for the Brain Resuscitation Clinical Trial II, a multicenter, placebo-controlled trial to evaluate the efficacy of the calcium-entry blocker lidoflazine in the amelioration of brain damage in comatose cardiac-arrest survivors, posed unexpected challenges. Concern arose when monitoring of adverse reactions showed an excess of dangerous cardiac arrhythmias, including rearrest, in the lidoflazine group. To ascertain the cause of this problem and determine whether it was ethical for the trial to continue, an in-depth review of data was conducted, outside experts were consulted, and additional data were collected. These efforts suggested possible causes for the problem. Existing drug administration protocols for blood pressure control were reinforced, resulting in lower subsequent arrhythmia rates. Thus, through an efficient monitoring system, an important problem was uncovered and resolved, allowing the trial to be completed without major changes.

Flow resistance of expiratory positive-pressure systems.

We measured the flow-resistance of five commercially available 10 cm H2O expiratory positive-pressure (EPP) valves (n = five per valve type) at bias flows of between 0 and 2,000 ml/s. We found that individual valves of each type and manufacturer functioned similarly. Different valve types, however, functioned differently: with one type, system pressure was higher than rated (p less than 0.05), and with another type, system pressure was significantly flow-dependent (p less than 0.01). The remaining types of valves had no flow-resistive properties and maintained a system pressure of 10 cmH2O. We conclude that system pressure is not similar in all continuous positive airway pressure (CPAP) systems using bias flow and EPP valves. The work of breathing imposed by CPAP circuits will be increased in systems whose EPP valves have flow-dependent properties.

Do periodic hyperinflations improve gas exchange in patients with hypoxemic respiratory failure?

Prolonged artificial ventilation may result in worsening gas exchange and pulmonary compliance in patients with otherwise normal lungs. Prolonged hyperinflations to 40 cm H2O can completely reverse deterioration of gas exchange and compliance in such patients. Similar efforts have effectively recruited atelectatic lung regions in critically ill patients. Less aggressive hyperinflations have not improved lung function in patients with abnormal lungs with hypoxemia. However, sustained exaggerated hyperinflations may successfully open collapsed lung units in these patients when standard recruitment techniques fail. We compared periodic hyperinflations of 40 cm H2O lasting 15 to 30 sec associated with body positioning (directed recruitment [DR]) to standard bag-sigh-suctioning (BSS) for their effects on gas exchange and pulmonary compliance in 16 stable surgical ICU patients with hypoxemic respiratory failure of 24-h duration or longer. Patients were sequentially alternated between DR and BSS (group 1, BSS followed by DR; group 2, DR followed by BSS). Neither technique, alone or in sequence, resulted in a sustained (greater than or equal to 5 min) improvement or deterioration in either gas exchange or pulmonary compliance. We conclude that neither BSS nor DR reliably affects gas exchange or compliance in patients with established hypoxemic respiratory failure.

Hospital guidelines for deciding about life-sustaining treatment: dealing with health "limbo".

The decision to withhold life-sustaining treatment from hopelessly ill patients is fraught with ethical dilemmas and legal uncertainties. Although there are extensive published commentaries on the subject and the law is gradually becoming clearer, care-givers often need concrete guidance when confronted with actual cases. Hospital ethics committees can assist care-givers, patients, and families in resolving these dilemmas, but the committees also need some specific guidance to be relatively consistent. Therefore, the Ethics and Human Rights Committee of Presbyterian-University Hospital, one of the University Health Center Hospitals in Pittsburgh, has developed guidelines for deciding about life-sustaining treatment.