NAPS & CAPS

Introduction NAPS CAPS Sources

 

Introduction

Most endoscopic procedures in the United States are performed using some form of sedation, offering benefits for both the patient and the physician. The most common method utilizes moderate or conscious sedation with a goal of relaxing the patient while maintaining reflexes and cardiovascular and respiratory function. This enables the endoscopist to perform a more thorough exam with less risk of injury. The following section will highlight Nurse Administered Propofol Sedation (NAPS) and Computer Assisted Personalized Sedation (CAPS).

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Nurse-Administered Propofol Sedation (NAPS)

NAPS Introduction

According to the American Society for Gastrointestinal Endoscopy (ASGE) position statement, 2009 “Non-anesthesiologist administered propofol (NAAP) describes the administration of propofol under the direction of a physician, who has not been trained as an anesthesiologist."A level of moderate-to-deep sedation is targeted with NAAP, using propofol either alone or in combination with one or more other agents. Propofol represents an option for patients undergoing sedation for gastrointestinal endoscopy; when optimally administered, it may offer more rapid cognitive and functional recovery. Currently, propofol is off-label for use by non-anesthesiologists, which has raised safety and liability questions for nurses, gastroenterologists and facilities.

Nurse-Administered Propofol Sedation (NAPS)

Definition:

  • “The administration of propofol by a registered nurse under the direction of a physician who has not been trained as an anesthesiologist.” ASGE 2009
  • “A level of deep sedation is the target with NAPS." ASGE 2009

Nurse’s Role during NAPS

  • Administration of propofol through physician ordered titration and patient monitoring
  • Need to anticipate portions of the procedure that may be more painful or stimulation in order to anticipate the need for more sedation
  • Vigilant monitoring of the airway
  • Continuous monitoring of respiratory rate, blood pressure, heart rate, oxygenation status and end tidal carbon dioxide level
  • NAPS intended as a monotherapy

Balanced Propofol Sedation (BPS)

Definition:

  • ASGE (2009) defined BPS as “the administration of the combination of a benzodiazepine, an opioid, and propofol under the direction of a physician who is not as anesthesiologist."

Advantages and Disadvantages of Propofol

Advantages:

  • Used as an alternative to standard benzodiazepine and opioid-based regimes
  • Ultra short onset of action, approximately 30-60 seconds
  • Rapid redistribution throughout the entire body
  • Peak effect in about one to three minutes
  • Short half-life
  • Minimal risk of nausea
  • Short recovery time

Disadvantages

  • Contains no analgesic effects
  • Patients may experience agitation, confusion and withdrawal from painful stimuli
  • Narrow therapeutic range, must be titrated carefully to achieve sedation
  • Patients may develop profound respiratory depression
  • No pharmacological reversal
  • No antagonist for propofol
  • Patients experiencing overdose will need assistance with ventilation until spontaneous ventilation resumes
  • Propofol can also cause a drop in blood pressure and heart rate
  • Propofol is vulnerable to microbial contamination
  • Once drawn up should be used within a few hours
  • Adherence to strict infection prevention measures must be taken when drawing up and administering propofol.

Patient Care and Monitoring

In January of 2011, Centers for Medicare and Medicaid Services (CMS) revised their guidelines concerning anesthesia services. This required hospitals to develop and implement sedation policies and procedures that “address whether specific clinical situations involve anesthesia versus analgesia.” (CMS 1-14-2011 revised Guideline)

CMS further identified the need for hospital to base their policies on nationally recognized guidelines. The patient care assessment and monitoring should be consistent with that of the care of a patient undergoing deep sedation.

Policies

At each endoscopy suite, an interdisciplinary team should establish policies and practice guidelines for the administration of propofol. The American Society of Anesthesiologists and the American Association of Nurse Anesthetists state that only persons trained in the administration of general anesthesia, who are not simultaneously involved in the procedures, should administer propofol. Because regulations governing sedation administration by nursing personnel vary from state to state, it is important for nurses and physicians to understand state licensure, state nurse practice acts, and individual institutional policies. If the facility chooses to support nurse-administered propofol sedation, the circumstances and required education and mentorship that must be accomplished need to be specified beforehand, as well as competencies that must be met periodically, such as ACLS certification. A continuous monitoring process needs to be established (e.g., vital signs, oxygen saturation, ECG, and possibly capnography). Equipment must be readily accessible at the point of care to maintain a patent airway, provide oxygen, intubate, ventilate, and offer circulatory resuscitation.

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Computer-Assisted Personalized Sedation (CAPS)

Computer-assisted personalized sedation (CAPS) devices seek to make the delivery of propofol sedation predictable, precise, and safe by using computer algorithms to calculate and deliver appropriate amounts of propofol, based on quantifiable physiological parameters. Physiological patient data (i.e., oxygen saturation, capnometry, respiratory rate, heart rate, blood pressure, electrocardiography, and patient responsiveness) are monitored continuously. The device then processes these physiological data and, using a computerized drug delivery algorithm, is able to titrate sedation by varying the propofol infusion and administering boluses of propofol.

It is also able to increase oxygen delivery in response to hypoxemia and apnea.An important part of the system is the automated responsiveness monitor, or ARM, which is designed to assess patient responsiveness.At preset intervals, it delivers an auditory request to the patient together with a mild vibration of the handset. If the patient fails to respond by squeezing the handheld switch, the verbal request becomes louder and more commanding and the handset vibration more vigorous. The ARM calculates and displays the patient response time to these stimuli and deems a lack of patient response within 14 seconds as unresponsive. Previous studies have demonstrated that the loss of ARM response precedes development of deep sedation and adverse physiological effects.

The system is designed to help physician/nurse teams deliver minimal to moderate propofol sedation to patients during endoscopic procedures without an anesthesia provider.

The device is restricted for use by health care professionals that have the types of training defined in the labeling, and to settings where an anesthesia professional is immediately available for assistance or consultation.  The four piece system includes:
  • Bedside Monitoring Unit (BMU) designed to stay with the patient from before the procedure, through the procedure and post-procedure recovery.
  • Procedure Room Unit (PRU) designed to stay in the procedure room and provides additional patient monitoring. It also contains the propofol infusion pump controller.
  • Display monitors and connectors.
  • Disposable devices for single patient use.

The pivotal study for CAPS demonstrated that healthy patients who were sedated using the device had lower occurrences of low blood oxygen levels (hypoxemia) compared to similarly healthy patients who were sedated with midazolam or similar medication during elective colonoscopy and upper endoscopy procedures. In the study, patients sedated with CAPS were associated with deeper-than-intended sedation in approximately 2.5% of patients. A simulation-based moderate sedation training program developed by the International Society for Anesthetic Pharmacology is expected to aid in preventing and mitigating these occurrences by expert instruction in the pharmacology of propofol and airway management. Post-approval studies will be conducted to evaluate the need for immediate availability of a trained anesthesia professional for safe use of CAPS.

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Sources

American Society of Anesthesiologists. (2010). Advisory on granting privileges for deep sedation to non-anesthesiologist sedation practitioners. Retrieved from http://www.asahq.org/~/media/Sites/ASAHQ/Files/Public/Resources/standards-guidelines/practice-guidelines-for-sedation-and-analgesia-by-non-anesthesiologist.pdf

American Society of Anesthesiologists. (2009).Safe Use of Propofol, Statement on.Retrieved from http://www.asahq.org/~/media/Sites/ASAHQ/Files/Public/Resources/standards-guidelines/statement-on-safe-use-of-propofol.pdf

American Society for Gastrointestinal Endoscopy. (2009). Position statement: Non-anesthesiologist administration of propofol for GI endoscopy. Gastrointestinal Endoscopy, 70(6), 1053-1059 

Centers for Medicare and Medicaid Services (CMS).(2011).Conditions of Participation, State Operations Manual, Appendix A Regulations and Interpretive Guidelines for Hospitals; 42 C.F.R. § 482.52 (Anesthesia Services).

Society of Gastroenterology Nurses and Associates (SGNA). (2013). Statement on the Use of Sedation and Analgesia in the Gastrointestinal Endoscopy Setting. Retrieved from: https://www.sgna.org/Portals/0/Education/PDF/Position-Statements/Sedation_2013-FINAL.pdf

American Society for Gastrointestinal Endoscopy Technology Committee. (2011). Report on Emerging Technology Computer-assisted personalized sedation.Gastrointestinal Endoscopy., 73, 423-427.

SEDASYS® Computer-Assisted Personalized Sedation System - P080009. Retrieved from http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm353950.htm

 

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