1. Program Information

2. Ethics in the Intensive Care Unit
Christine C. Toevs, MD
Trauma/ Critical Care Surgeon
MA Bioethics
21 Dec 2009

3. Care at the End of Life Cassell, 2003; Critical Care Medicine
Ethnographic study of three ICUs
Surgeons - most important goal is defeating death
Intensivists - scarce resources and quality of life
In this study 600 physicians, nurses and allies health personnel, patients, family members and friends were studied at a university hospital in the US and in New Zealand. This study concluded that end-of-life care varied depending on who had primary responsibility for the patient. If the surgeon was in charge, the most important goal was defeating death. When intensivists were in charge of the patient, scarce resources and quality of life were considered. 3

4. Care at the End of Life Surgeons - covenantal ethics:
surgeons define their relationship to the patient as a promise to battle death on behalf of the patient
choice is simple-life or death
quality of that life not an issue
Cassel’s study concluded that surgeons define their relationship in a convenantal relationship. Surgeons define their relationship to the patient as a promise to battle death on behalf of the patient. The only consideration is life or death. 4

5. Care at the End of Life New Zealand
Critical care physicians have legal authority and mandate to determine who is admitted to ICU
Decision to redirect treatment toward comfort measures is purely medical
Does not require assent of family or surgeon
Cassell points out that in New Zealand the relationship is different. Intensivists have the legal authority and mandate to determine who is admitted to the ICU. Decisions to redirect treatment toward comfort measures is purely medical – whether the treatment is medically beneficial and will reach the stated goals. 5

6. Care at the End of Life
New Zealand rations by limiting care to those judged able to benefit from such care
United States - largely indigent population has to “wait their turn” for access to care (ethic of scarce resources)
US rations by limiting those who care for ICU patients
In New Zealand, the purpose of an ICU is for cure. Admission to an ICU is based on whether such treatment will be medically beneficial. For example, patients with DNR orders are limited from ICU beds. In the US, despite the huge number of ICU beds (15% of all hospital beds), there is a limit of intensivists, nurses and ancillary staff to treat these patients. In the US we ration by limiting access. 6

7. Goals of Healthcare Restore health Relieve suffering
These goals are not incompatible. The treatment being offered must be defined within the context of the goals.
The goals of medicine are to restore health and relieve suffering. These goals are often lost in the “goal to cure”. Working with families and patients we can set realistic goals about what medicine can and cannot do. We are often not very good at having these discussions and allowing families and patients to participate in these decisions. Treatment must be defined within the context of the goals of restoring health and relieving suffering. 7

8. Geriatric ICU Care 50% ICU admissions over age 65 60% of all ICU days
ICU/hospital mortality for age > 60 = 70%
11% Medicare recipients spend > 7 days in ICU within 6 months before death
30% of Medicare costs in last year of life, 52% during last 60 days
The number of elderly in the US continues to grow. It is difficult to obtain accurate current data as most is from around year But at least 50% of al ICU admissions are over the age of 65 and account for 60% of all ICU days. The combined ICU and hospital mortality for people over the age of 60 is about 70% depending on which reference is cited. 11% of all Medicare recipients spend >7 days in ICU within 6 months before death. And 52% of all Medicare costs spent in the last year of life are spent in last 60 days. Medicaid increasingly pays for medical treatment and nursing home care for patients in this age group. Marik suggests in his paper that survival may not be the best outcome. He suggests that return to functional status is much more important and that many geriatric patients are “discharged to subacute facilities with persistent organ failure, where they linger for months before ultimately dying.” Studies are beginning to document outcomes regarding pre-illness status, discharge to facilities and 6 month and 1 year mortality. 8

9. Withdrawal of Treatment
Discontinuing a therapy that has disproportionate burden without achieving reasonable clinical goals
Withdrawing treatment is distinguishable from purposely hastening death (intent)
Withdraw of treatment is treatment that has been started, such as mechanical ventilation or dialysis or artificial nutrition and hydration. WD is discontinuing a therapy that has a disproportionate burden without achieving reasonable clinical goals. It is NOT hastening death. The goal is to stop nonmedically beneficial treatment and to relieve suffering. Intent matters. 9

10. Withholding of Treatment
Not initiating a therapy that has a disproportionate burden without achieving reasonable clinical goals
Withholding a treatment is not starting a treatment that has a disproportionate burden without achieving reasonable clinical goals. For example, a patient with overwhelming sepsis and an MI; we would not offer a heart transplant as that would not be medically beneficial. We would technically be withholding a treatment. However we decided medically that it would not benefit the patient. As a consequence, heart transplantation would not be offered the patient or the patient’s family. 10

11. Withdrawing vs. Withholding
Withholding a treatment is viewed as equivalent to withdrawing an intervention.
Distinction between failing to initiate and stopping therapy is artificial.
Justification that is adequate for not commencing treatment is sufficient for ceasing it.
Ethically, morally and legally withholding and withdrawing nonbeneficial medical therapy is identical. We often attach emotion to this process and think withdrawing is worse than withholding. However they are identical. It is reasonable to offer a trial of medical therapy with the intention of stopping (withdrawing) it if it does not work. For example a trial of ventilation or dialysis for a period of days. If no clinical improvement towards the goals set by the patient and the family, it is reasonable to stop it. 11

12. Withdrawal vs. Withholding
No presumption that, once begun, no matter how futile, the treatment must be continued.
No difference between withdrawal and withholding.
Not “care” but treatment. We still care for the patient but do not offer or continue non-medically beneficial treatment.
There is no obligation to continue treatment, once started, that is not medically beneficial. Once dialysis is started it is not required that it be continued until death. A trial may be done and if no improvement, then the therapy withdrawn. Permission from the family is not required. We continue to treat and care for the patient, but we do not offer nonmedically beneficial treatment. For example we may start antibiotics for a presumed infection. All cultures come back negative. We stop the antibiotics because they are not helpful. 12

13. Withdrawal and Withholding
% of ICU deaths preceded by decision to withdraw or withhold treatment
% of ICU deaths
Includes DNR orders
A study by Prendergast in Am J Respir Crit Care Med 1997 looked at limitations to life-sustaining care in critically ill patients. They determined that in % of deaths were preceded by limitations to treatment, while in % of deaths. This study included DNR orders. 13

14. Withdrawal of Mechanical Ventilation
N Engl J Med, 2003
15 ICUs
Examine clinical determinants associated with withdrawal of mechanical ventilation
851 patients:
539 weaned (63.3%)
146 died (17.2%)
166 withdraw (19.5%)
Cook, et al in NEJM in 2003 looked at 15 ICUs to determine the decision to withdraw mechanical ventilation in anticipation of death. 19.5% of patients had MV withdrawn 14

15. Withdrawal of Mechanical Ventilation
Need for inotropes or vasopressors
Physician’s prediction of survival < 10%
Physician’s prediction of limitation of future cognitive function
Physician’s perception that patient did not want life support used
Determinants for the decision to withdraw of mechanical ventilation included the need for inotropes or vasopressors, the physicians predication of survival and limitation of future cognitive function, and the physicians perception that the patient did not want life support used. 15

16. Withdrawal of Mechanical Ventilation
Not predictors:
age
severity of illness
organ dysfunction
Determinants of withdraw of mechanical ventilation did not include age, severity of illness or organ dysfunction. 16

17. Withdrawal of Mechanical Ventilation
Emphasize that life-sustaining therapy was not able to reverse the underlying disease.
Removal of life-sustaining therapy is allowing disease to take its natural course.
Aggressive palliative treatment
Withdraw of mechanical ventilation is morally and ethically required when it is no longer medically beneficial. When speaking to the family it is important to emphasize that life sustaining therapy is not able to reverse the underlying disease. For example, a ventilator will not treat or reverse terminal lung cancer. Removal of life-sustaining therapy is allowing the disease to take its natural course. Allow Natural Death. In all cases treatment of symptoms and continuing to treat the patient is crucial. The goal of therapy has changed from sustaining life at all costs to Allowing a Natural Death. Palliative treatment to treat symptoms and offer family and patient support is crucial. 17

18. Principle of Double Effect
Ensuring adequate palliation while differentiating clinician actions from active hastening of death
Distinction based on intent of action
Use of pain medicines to relieve pain and suffering
Fro most ethicists the issue of Double Effect is not as crucial as it once was. As we have become better with pain management, this issue is discussed less and less. The primary determinant is one of intent. If the goal is to relieve pain and suffering, high doses of pain medications may be required, especially as patients develop tolerance. Patients and families often need to be explained the goal of pain medications as they are often concerned that pain medications may hasten death. The goal is to relieve pain and suffering, not hasten death. 18

19. Active Euthanasia Actively shortening the dying process
Performing an act with the specific intent of shortening the dying process
Overdose of narcotics, anesthesia, paralytics, etc.
It is not the absolute dose of narcotics, but a change in the dose
Active Euthanasia is a term that is becoming less used because of the confusion between active and passive euthanasia (withdraw of medical therapy). Generally the term used now is Physician Assisted Suicide. The intent is to shorten the dying process. 19

20. Decisional Capacity
Understand relevant information and decision at hand
Appreciate significance and relate it to own life
Reason through options and outcomes
Make and articulate a choice
We are often in the position of having to determine the Decisional Capacity of a patient. There are 4 determinants: Are they able to understand relevant information and the decision at hand? Do they appreciate its significance and can relate the decision to their own life? Can they reason through options and outcomes? Can the make and articulate a choice? 20

21. Surrogate Consent Patient lacks decisional capacity
Apply substituted judgment
Promote patient’s wishes and express beliefs of the patient
“What would your loved one do in this situation?”
Avoid implication of “pulling the plug”
Not ending life but avoiding prolonged suffering
If a patient lacks decisional capacity, then a surrogate decision maker is used. The surrogate must be able to apply substituted judgment; not what they would want, but what they patient would want if they could speak for themselves. The focus must be on the patient and what they would want in this situation. The goal is not to end life, but to relieve suffering. 21

22. Withholding Treatment
Case scenario:
60-year-old male
Widely metastatic colon cancer
S/p exp lap, bypass of obstructing lesion
Develops SOB on floor, transferred to ICU
Minor distress, unable to give consent, no family at all
Would you intubate him? 22

23. Withholding Treatment
Options:
Intubate him
Trial of days to see is he improves on vent
Continue intubation until he dies in ICU
Do not intubate him
Several MDs document that mechanical ventilation will not benefit him medically
Continue to provide comfort therapy
There are options in this situation. It is unlikely that a ventilator will reverse his clinical course. It is appropriate to not offer a ventilator in this situation. Two physicians document that a ventilator would not provide medically beneficial therapy. They can also make him DNR or AND – Allow Natural Death. Comfort measures and treatment of his symptoms are crucial. 23

24. Withholding Treatment
“For a patient with metastatic cancer and liver failure, respiratory support on a ventilator does not even have to be offered because it will only prolong a death rather than provide treatment of the disease.”
Henig and Faul, intensivists at Stanford wrote an article entitled ‘Biomedical Ethics and the Withdrawal of Advanced Life Support’ (Annual Review Medicine 2001). They discussed that ‘all treatment options should not be made available to every patient. ‘ 24

25. Non-medically Beneficial Treatment (Futile Care)
Is patient autonomy really the utmost ethical guideline?
Do we not have a responsibility to use the medical decision-making skills that we have?
Futile care is difficult to define. A better term is nonmedically beneficial treatment. Although patient autonomy is critical, we are not obligated to provide nonmedically beneficial treatment. Even if the patient demands it. 25

26. Non-medically Beneficial Treatment (Futile Care)
It is well established in medical ethics and law that it is appropriate to withhold medical intervention when such interventions provide no reasonable likelihood of benefit to the patient.
We are not obligated morally, ethically or legally to provide nonmedically beneficial treatment, even when demanded by the patient or the surrogate. For example, we are not obligated to provide antibiotics in the case of a viral infection. We are not obligated to offer them and have the patient or surrogate make that decision. Granted it takes time to explain why it is not medically beneficial and will not help, but that is part of our responsibility as physicians. 26

27. Non-medically Beneficial Treatment (Futile Care)
“There is no duty to offer a cancer patient access to Laetrile or other unproven forms of therapy and no duty to offer a patient a futile surgical intervention.
Weil in an editorial for CCM in 2000 (How to respond to family demands for futile life support and CPR. CCM : ) He also went on to state that there is no obligation to offer CPR in futile situations. Physicians do have an obligation to talk with patients and families about our medical judgments, including whether a treatment will be beneficial. 27

28. Rule of Rescue
Hadorn, 1991
Powerful human tendency to act to save an endangered life
Implies that available technology be used when even small chances of cure are possible
Hadorn in JAMA in 1991 wrote about the Rule of Rescue. Rule of Rescue is the powerful tendency to act to save an endangered life. The Rule of Rescue implies that all available technology be used when even small chances of cure is possible. Any limitations to this technology hails cries of “rationing” when other terms may be more appropriate. 28

29. “Everything Done” Case scenario:
85-year-old male, MVC, pelvic fx and facial fx
“Codes” in CT
CPR for 20 minutes
Brought to ICU
On 2 pressors with BP in 70s
Family “wants everything done” 29

30. “Everything Done”
What would you do?
PA cath
CPR
Dialysis

31. “Everything Done”
Determine what the family means by “everything done.”
Most families want reassurances that their loved one did not have a survivable incident and all appropriate medical therapy was offered/done.
Are not obligated to provide care that we believe to be non-medically beneficial
Family present at interventions (resuscitations)
The most important point is communication. Families demand that “everything be done”/ What exactly does that mean? We have an obligation to speak with the family and determine their goals for treatment and to help them understand the medical treatments. In the previous case, a discussion with the family that everything was being done, and that he was still dying, brought understanding and a request to WD the ventilator and allow a natural death. Families present at resuscitations help them see their loved ones receiving treatment, that efforts are being made to save their life. 31

32. Non-medically Beneficial Treatment (Futile Care)
How is medical futility defined?
Disease must be terminal
Disease must be irreversible
Death must be imminent
Merely preserves permanent unconsciousness or cannot end dependence on intensive medical care
Clear legal definition does not exist
As discussed earlier there is not a clear definition of futility. Most define it as less than 10% chance of survival. In medicine today the goal has become cure at all costs many times, and even less than 10% survival is not seen as futile. Most agree that the disease must be terminal, irreversible, with death imminent. 32

33. Non-medically Beneficial Treatment (Futile Care)
Reasons for clinician distress
want to minimize suffering
reluctance to provide care that they would not want for themselves or family
not a good use of resources
lack of trust that family not following recommendations
feelings of distaste at inflicting physical abuse on dead or dying people
Curtis and Burt wrote a commentary in J Crit Care in They stated intensive care nurses and physicians experience intense frustrations providing treatment they believe to be futile. The distress occurs because intensivists want to minimize suffering, are reluctant to provide care they would not want for themselves or family. Intensivists believe futile care is not a good use of resources. It frustrates them that family is not following recommendations to limit or withdraw life sustaining therapies. And the clinicians feel distress at inflicting physical abuse on dead or dying people. 33

34. Non-medically Beneficial Treatment (Futile Care)
Case scenario:
85-year-old male
MVC, rib fx
Vent.-dependent for 6 months
Wife continues to “want everything done”
Develops renal failure

35. Non-medically Beneficial Treatment (Futile Care)
Would you offer dialysis?
If so, why?
If not, why not?

36. Non-medically Beneficial Treatment (Futile Care)
“Physicians are not obligated to provide care they consider physiologically futile even if a patient or family insists. If treatment cannot achieve its intended purpose, then to withhold it does not cause harm. Nor is failure to provide it a failure of standard of care.”
Luce in CCM in 2001 (End-of-Life Care: What do the American Courts Say?) discussed the legal setting around futility. In the previous case the intensivists all agreed that dialysis would not achieve its intended purpose and did not offer it. The wife demanded it and threatened to sue. However the intensivists obligation is to the patient. Dialysis in this care would not be medically beneficial. To provide it because the wife demanded it or threatened to sue would be unethical. 36

37. Non-medically Beneficial Treatment (Futile Care)
“Physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. Patients should not be given treatments simply because they demand them. Denial of treatment should be justified by reliance on openly stated ethical principles and acceptable standards of care, not on the concept of ‘futility,’ which cannot be meaningfully defined.”
The AMA in the Report of the Council on Ethical and Judicial Affairs stated that we are not obligated to provide nonmedically beneficial treatment. 37

38. Legal Issues
Competent adult has the right to refuse life-sustaining treatment
Quinlan - substituted judgment
Medical interventions not distinguished by “extraordinary” and “ordinary”
Medical interventions evaluated by benefits and burdens offered
The Supreme Court has ruled that competent adults have the right to refuse life sustaining treatment, including antibiotics, artificial nutrition and hydration, ventilators, surgery, chemotherapy, etc. Karen Ann Quinlan was a patient with anoxic brain injury in the 1970’s. Her father wanted to WD the ventilator. The doctors said no. It went all the way to the Supreme Court, who ruled that her father was legally responsible as surrogate to make medical decisions for her. She was withdrawn from the ventilator and lived for several years in a persistent vegetative state. This Supreme Court ruling set the guidelines for surrogate decision making. 38

39. Legal Issues
Cruzan - principle that a competent person’s right to forgo treatment, including nutrition and hydration, protected under 14th amendment
Nancy Cruzan from the 1990’s also had an anoxic brain injury. Her family wanted to stop artificial nutrition and hydration. The Supreme Court heard this case and stated that Missouri had a compelling reason to make sure this is what she would have wanted. A college friend came forward and said Nancy Cruzan had stated she would not have wanted to live like this. The Supreme Court also stated that artificial nutrition and hydration (ANH) is just like any other medical therapy and can be refused. 39

40. Legal Issues
Only clear legal rule on medically futile treatment is traditional malpractice test
Likely to get better legal results when refuse to provide nonbeneficial treatment and then defend position in court as consistent with professional standards than when seek advance permission from court to withhold treatment
Luce also includes in his article that there are no clear legal standards on medical futility. 40

41. CPR Developed in 1960s Intended for victims of unexpected death:
drowning
drug intoxication
heart attacks
asphyxiation
75% survival on television
15% survival of hospitalized patients
CPR is interesting. Designed for victims of unexpected death it is now applied to all patients who die without a DNR order. It is the only procedure in the hospital that occurs without an order. The expectations for recovery are affected by depictions on television (NEJM 1996). Although recent studies suggest the short term outcome is predicted more accurately on television, the long term outcome and specific outcome is not depicted (Resuscitation 2009) 41

42. CPR
Not intended as a routine at time of death to include cases of irreversible illness for which death was expected
Unclear how it became the “standard of care”
Unique among medical interventions as it requires a written order to preclude its use 42

43. CPR
“A physician’s decision supported by consultants to withhold CPR is a medical decision and cannot be overridden. Patient autonomy and consumerism does not extend to medically futile care.” Weil, 2000
A DNR order does not require patient or surrogate decision maker request or agreement. We are not required to offer medical therapy that is not beneficial. For example, a gunshot wound to IVC and the trauma surgeon cannot stop the bleeding. Eventually the patient will esanguinate and his heart will stop. CPR will not restore blood flow and therefore is not indicated. The decision to not provide CPR is a medical one. To provide it gives false hope to the family and utilizes scarce resources in the ICU. Weil 2000 and Curtis 2003. 43

44. CPR Physically and emotionally traumatic
Significant likelihood of iatrogenic injury
Disrupts the care of the living
Communicates false hope to the families
CPR is physically and emotionally traumatic to the patient and the providers. There is a significant chance of iatrogenic injury. As CPR mobilizes teams of providers, it disrupts the care of the living, especially in an ICU setting. And it communicates false hope to the families. It should not be provided when it is not medically beneficial. 44

45. CPR
Moral, ethical, and legal justification for a physician’s refusal to perform CPR when there is medical consensus that CPR will not be beneficial
Weil and Curtis 45

46. CPR Predictors of outcome: Favorable
respiratory arrest
unexpected
witnessed
Unfavorable (no survival to discharge)
not witnessed
pulseless electrical activity
asystole

47. CPR Age is not a major predictor of outcome.
Underlying medical conditions are a predictor.
CPR greater than 10 minutes - no survivors
In cases where CPR is provided when it might be survivable – CPR greater than 10 minutes has no survivors to discharge. A letter to the editor in NEJM 2009 regarding in hospital CPR recommended DNR as the universal default. Given the basic principle of informed consent, Wallace recommended that CPR be held to the same standards of informed consent, rather than the default. 47

48. CPR Greek study, Resuscitation, 2003 CPR in general adult ICU
111 patients
CPR performed in 98.2% within 30 seconds
24-hour survival - 9.2%
Survival to discharge - 0
Within an ICU, CPR is rarely is ever beneficial. That is because the heart rarely stops as a primary cardiac event, but rather is a symptom of multisystem organ failure. 48

49. DNR
“DNR orders only preclude resuscitative efforts in the event of cardiopulmonary arrest and should not influence other therapeutic interventions that may be appropriate for the patient AMA
DNR does not mean do not treat. We continue to treat the patient. We just do not provide CPR when the patient dies. 49

50. Summary Death is a process, not an event.
Dignity in dying is as important as preserving life.
Palliative treatment is a crucial part of ICU care.
Withdraw and withholding are equivalent.
Early and frequent communication with families is important.
The goal of medicine is to relieve suffering and restore health. We are not obligated to provide treatment that is not medically beneficial and will not help the patient reach those goals. Allow Natural Death is an option that includes withdrawing and withholding life sustaining therapies. Frequent communication with the family and patient is required – morally and ethically. 50

51. Conclusion ICUs have 2 major goals:
Save lives by intensive and invasive therapies.
Provide a peaceful and dignified death when death is inevitable.
Early use of Palliative Medicine will help to establish goals of treatment and provide support for the family during the difficult time of an ICU admission. Palliative Medicine can also offer continuity in goals in the ICU and on the ward. 51

52. Review
The follow are question to help you review the key points of this presentation.
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53. Ethics Review

54. References
Cassell, et al. Surgeons, Intensivists, and the Covenant of Care: Administrative Models and Values Affecting Care at the End of Life. CCM :
Civetta, Taylor and Kirby’s Critical Care. 4th Edition Lippincott
Gries, et al. Family Member Satisfaction with End-of-Life Decision Making in the ICU. Chest :
Halpern, Pastores. Critical Care Medicine in the United States : An Analysis of Bed Numbers, Occupancy Rates, Payer Mix, and Costs. CCM :65-71
Lubitx and Riley. Trends in Medicare Payments in the Last Year of Life. NEJM :
Mitchell, et al. The Clinical Course of Advanced Dementia. NEJM :29-38
Tamura, et al. Functional Status of Elderly Adults before and after Initiation of Dialysis. NJEM