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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.

Definitions and Terms

  • ▪  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.

Figure 6-1.

Signature portion of a universal consent for a variety of intensive care procedures.


  • ▪  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).

Figure 6-2.

Intensive care procedure documentation template.

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