Patient autonomy is a pillar of clinical ethics, and it’s vital to the integrity of any clinical practice.

Observance of this principle works to uphold patients’ rights, fosters trust and collaboration, respects diversity, and empowers individuals to actively participate in decision-making regarding their healthcare.

In our efforts to protect patient autonomy, one of the best tools we have is informed consent. This is something of which every clinician is acutely aware, not least in the ICU.

Before we begin any surgical procedure, for instance, surgeons and anesthesiologists ensure informed consent is obtained from the patient and/or their family. Any risk, no matter how unlikely, is disclosed so patients and families are able to make their best decision and clinicians are protected from legal liabilities.

Even routine procedures like inserting a central venous catheter, arterial line, or endotracheal tube, or performing diagnostic tests, like a CT scan, require us to obtain informed consent.

In the ICU, the process of obtaining informed consent is ubiquitous, and no experienced clinician would question the legitimacy of this process.

When it comes to sedation, however, there is no standardized requirement for informed consent. Culturally, it is not considered to be necessary to tell patients and/or families of the life-threatening and life-altering risks of continuous sedation.

But the truth is, the risks of prolonged sedation can be just as serious as anything else we do in the ICU, and the need to obtain informed consent is just as important for sedation as it would be for surgery.

With that in mind, patients and their families need to be properly informed of the risks of sedation, and the risks of immobility, delirium, ICU-acquired weakness, and everything else that’s associated with being sedated.

Neglecting to obtain this informed consent is putting patients at risk, exposing ICU clinicians and the hospitals where they work to potentially serious legal consequences, and eroding hard-won trust in our healthcare systems.

In this article, we’ll be exploring the ethical conflict and legal liabilities of failing to inform patients and/or families of the risks of sedation and why in many cases, it’s so important to offer the option of avoiding sedation.

 

Why Aren’t Clinicians Obtaining Informed Consent for Sedation?

Truth be told, despite all the evidence to the contrary, many clinicians don’t consider sedation to be a dangerous intervention.

In the ‘90s, sedation became synonymous with intubation, and back then, we hadn’t done the research to show the risks of sedation, so no one was the wiser.

Several decades later, sedating every intubated patient has become standard practice in most ICUs.

This “malignant normality” leads us to believe that sedation for every intubated patient is an unavoidable, routine, and even benign practice, and this prevents clinicians from seeing the reality of sedation and immobility.

Believe it or not, most clinicians are actually unaware of the risks patients incur the moment they start continuous sedation drips.

This perspective prevents clinicians from critically thinking and performing a risk versus benefit analysis prior to starting sedation.

And when clinicians believe that sedating every intubated patient is a non-negotiable necessity for everyone, then there is an innate assumption that there is no need to obtain informed consent.

To be clear, clinicians do not intend to harm patients or have unethical practices. But when they don’t know the risks at hand, they are unable to be honest and transparent with families and/or patients.

Nonetheless, the risks of sedation are very real, and it should be standard practice to make patients and/or their families aware of this and obtain true informed consent before sedation is started.

 

What Are the Risks of Sedation?

For many years now, ICU clinicians have been operating on the assumption that sedation is “sleep.”

They believe that keeping intubated patients heavily sedated is harmless and the most humane thing we can do for them.

Unfortunately, nothing could be further from the truth, and this is backed up by 20 years’ worth of research, which has shown that it’s actually the opposite that’s true.

But informing clinicians of the risks of sedation, and all the side effects that go along with it, is the first step in exposing these myths for what they are and putting an end to these assumptions once and for all.

With that in mind, below I’ve listed some of the risks of sedation, so you can have a better idea of the harm it can actually cause.

Sedation increases patients’ chances of:

• Dying in the ICU
• Dying after leaving the ICU
• Delirium
• ICU-acquired weakness
• Infection
• Pressure sores
• Blood clots
• Having to spend more time on the ventilator
• Requiring more time in the hospital
• Tracheostomy
• Being discharged to a rehabilitation center or nursing home
• Post-ICU PTSD
• Post-ICU dementia (cognitive dysfunction)
• Long-term physical disabilities
• Depression
• Being readmitted to the hospital or ICU
• Post-intensive care syndrome

 

Sedation decreases patients’ chances of:

• Being able to go home after being discharged from the hospital
• Being able to walk when being transferred from the ICU
• Having the ability to return to work
• Enjoying optimal quality of life

 

In any case, deep sedation is an automatic predictor of mortality, and families have a right to know.

That being said, before starting sedation, no matter the circumstances, it is our duty as clinicians to obtain informed consent.

If you’d like to learn more about patient autonomy, informed consent, and the risks of sedation and immobility, you should check out Episode 62 of my Walking Home From The ICU podcast.

 

What Are the Benefits of Avoiding Sedation?

In the ICU, there are some situations where sedation is absolutely necessary, including things like intracranial hypertension, seizures, open abdomen surgeries, inability to oxygenate with movement, and even some drug toxicities or severe alcohol withdrawal, for example.

Fortunately, in many circumstances that require mechanical ventilation, avoiding sedation is in the best interests of everyone involved.

Nonetheless, the incredible contrast in outcomes between having patients awake and mobile during mechanical ventilation versus having them sedated and immobilized is grossly underappreciated.

And the reason for this is that most ICU clinicians have never had the opportunity to experience the success that tends to go along with having patients walking while intubated.

Yet when the benefits of avoiding sedation are listed, it becomes clear why informed consent is so important when it comes to this practice, and why, whenever possible, families and patients should have the option to avoid the risks of sedation.

Avoiding sedation has been shown to decrease:

• Death
• Ventilator and hospital-associated pneumonia
• Central line and catheter infections
• Pressure injuries
• Falls
• Delirium
• Aspiration pneumonia
• Constipation/ileus
• Intubation
• Re-intubation
• Tracheostomy and PEG tube placements
• Discharges to care facilities
• Hospital and ICU readmissions
• Diaphragm dysfunction
• ICU-acquired weakness
• Long-term cognitive impairments

 

Avoiding sedation has been shown to increase/improve:

• Successful extubation
• Discharges from ICU
• Discharges home
• Chances of survival
• Functional independence after discharge
• Quality of life
• Lung aeration
• Secretion clearance

Truth be told, the risks of sedation and immobility are far higher than many of the risks of surgery that are explained when obtaining informed consent for those procedures.

With that in mind, families and patients have the right to be aware of the damage that can be done by sedation and the potential impact it can have on short and long-term outcomes.

Moreover, the process of obtaining informed consent for sedation empowers patients and families to actively engage in their healthcare decisions. This creates a patient-centric environment that enhances trust, communication, and the overall quality of care, and strengthens the patient-provider relationship.

At the same time, clinicians can be safeguarded from legal and ethical dilemmas when informed consent for continuous sedation is honest and transparent.

And as clinicians who want nothing more than to save and preserve lives, our patients and their families should expect nothing less.

 

Do you want to implement evidence-based sedation and mobility protocols in your ICU? We can guide you through the entire transformation, and we look forward to discussing your team’s needs. Please contact us here.