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Many invasive procedures, such as central venous access and endotracheal
intubation, clearly require prospective informed consent from the
patient or a proxy. Other procedures may not require consent, such
as enteral tube placement or urinary catheterization, although these
procedures are not entirely risk-free. In practice in the ICU, it
is often necessary to get consent from a proxy, because the critically
ill patient is unable to give informed consent. In addition to documentation
of informed consent, most procedures should be documented in the
medical record and in many cases this includes the need for an insertion
and a removal note.
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Definitions and Terms
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- ▪ Informed consent: The legal and ethical obligation
to provide a patient with information necessary to make a fully
informed decision about a procedure or treatment.
- ▪ Informed consent elements:
- —Discussion of the nature of the procedure
with the patient
- —Discussion of reasonable alternatives to the procedure
- —Relevant risks, benefits
- —Patient acceptance/agreement
- ▪ Implied consent: The concept that a reasonable person
would choose to undergo treatment or procedure when in similar circumstances—may
be applied under emergency circumstances when the patient is unable
to consent and a proxy cannot be reached.
- ▪ Consent form: The document used to record the consent process,
typically detailing the elements of consent as well as the signatures
of the parties to the consent.
- ▪ Universal consent form: A form developed to allow the patient
to consent to a number of common ICU procedures (ie, line placement,
line changes, endotracheal intubation) on admission to the ICU eliminating
the need for consent on a procedure-by-procedure basis (Figure 6-1).
- ▪ Healthcare proxy: An agent appointed by a patient to make
medical decisions in the event that the patient is incapacitated
and unable to make decisions on their own—in certain states
(ie, New York), family members do not have the authority to make
medical decisions for incapacitated adults.
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- ▪ Prior to a planned procedure, the provider credentialed
to perform that procedure should obtain consent from the patient
or proxy, and document same in the medical record
- ▪ After the performance of the procedure, a “procedure
note” should be placed in the medical record (Figure 6-2)—this
note serves as a record of the time, technique, medications used,
location, and complications (if any) of the procedure.
- ▪ In many cases, it is appropriate to document discontinuation
of a device (ie, extubation note, discontinuation of central line)
both to delimit the period of the device’s use and to document
the process of discontinuation and any associated problems (ie,
patient self-extubation).
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