1. Provide Physician Oversight and Direction
A credentialed staff physician is ultimately responsible for ensuring that appropriate care is provided to the patient during all phases of sedation. When the physician ordering sedation is not on site at the time of sedation, a qualified physician will be designated to be on-site and responsible for the sedation including assessment and monitoring during the pre-, intra- and post-sedation phases.
In the event that the physician responsible for the sedation is not available for any part of the sedation and procedural period, s/he shall delegate the care to another clearly identified qualified physician who has accepted the responsibility and is knowledgeable about the patient's condition.
A credentialed physician will:
- Assess and document a patient's appropriateness to receive sedation prior to receiving any sedative drugs as evidenced by his/her signature on the appropriate sedation form
- Re-evaluate the patient immediately prior to sedation administration as evidenced by his/her signature on the appropriate sedation form
- Order and direct the administration of sedation based on findings of the pre-procedure assessment
- Be on site and able to respond to changing patient status and treat complications of sedation that may occur
- Be able to rescue patients that unavoidably slip into a level of deep sedation, and
- Have immediate (STAT response) access to support from Anesthesiology or the Blue Cart Team, OR if offsite, must be able to demonstrate competency to provide continuing respiratory and cardiac life support measures (e.g., Active certification in Advanced Cardiac Life Support (ACLS)
- Have immediate access to obtain additional assistance for transport to an appropriate hospital care unit.
2. Perform and Record a Patient Assessment
A collaborative patient assessment for sedation is essential for safe and effective care. Both the physician and the nurse have a role in patient selection and preparation for procedural sedation. It is mandatory that certain key elements of the physical assessment and patient interactions be documented before sedation is given, even if a full dictated note is to follow. These include:
- Evidence of informed consent
- Assessment and documentation of patient appropriateness to receive the planned sedation based on the pre procedure history and physical
- Re-evaluation of patient immediately prior to sedation administration
Pre-procedure History and Physical
Pre-procedure assessment for risk factors is the first step in providing safe and effective sedation. Cardiopulmonary compromise, prior history of difficulty with sedation, and risk for difficult intubation are a few of the assessment parameters to identify patients at risk for complications related to sedation.
Pre-procedure assessments may be documented on a variety of forms in a variety of ways. Physicians may delegate part(s) of the assessment to qualified nursing staff but are ultimately responsible for assuring that the appropriate pre procedure assessment is completed. Pre procedure assessment includes (but may not be limited to):
- Current medications (including recent narcotics and sedatives within the past 24 hours)
- Previous problems with sedation/analgesia
- Heart rate, blood pressure and respiratory rate
- Oxygen saturation
- Level of awareness (consider mental status/orientation)
- Time of last PO intake
- Respiratory and cardiovascular status which may include findings from heart and lung auscultation and other physical findings as appropriate
- Assessment for risk of airway compromise
- Baseline assessment of pain, where appropriate
- Baseline Modified Aldrete Sedation Score (minimum score of 8 recommended for moderate sedation)
- Final verification to confirm the correct patient, procedure, and site using a "time out"
- Marking of surgical site involving right/left distinction, multiple structures (such as fingers or toes) or levels (such as spine). Teeth do not require marking.
Before any operative or invasive procedure, Universal Protocol must be followed.
Universal Protocol For Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery™
The following steps, taken together, comprise the Universal Protocol for eliminating wrong site, wrong procedure, wrong person surgery:
Pre-operative verification process
- Purpose: To ensure that all of the relevant documents and studies are available prior to the start of the procedure and that they have been reviewed and are consistent with each other and with the patient's expectations and with the team's understanding of the intended patient, procedure, site and, as applicable, any implants. Missing information or discrepancies must be addressed before starting the procedure.
- Process: An ongoing process of information gathering and verification, beginning with the determination to do the procedure, continuing through all settings and interventions involved in the preoperative preparation of the patient, up to and including the "time out" just before the start of the procedure.
Marking the operative site
- Purpose: To identify unambiguously the intended site of incision or insertion.
- Process: For procedures involving right/left distinction, multiple structures (such as fingers and toes), or multiple levels (as in spinal procedures), the intended site must be marked such that the mark will be visible after the patient has been prepped and draped.
"Time out" immediately before starting the procedure
- Purpose: To conduct a final verification of the correct patient, procedure, site, position, equipment and as applicable, implants.
- Process: Active communication among all members of the surgical/procedure team, consistently initiated by a designated member of the team, conducted in a "fail-safe" mode, i.e., the procedure is not started until any questions or concerns are resolved.
After reviewing the findings from the pre-procedure history and physical, the physician makes a determination as to the patient's appropriateness to receive sedation and the type of sedation to be used.
Immediately prior to sedation administration the physician will re-evaluate the patient and will attest to their continued appropriateness to receive the planned procedure and sedation. This is evidenced by the physician signature on the sedation documentation form. Medical staff should collaborate with nursing staff regarding the documentation forms and process used for a particular procedure in their respective patient care areas. Documentation forms are available in both the inpatient and outpatient settings. These forms have helpful prompts for aiding in completion of the pre procedural work up, as well as, documentation of intra and post procedural monitoring and assessment requirements.
* Airway Assessment
Pre-procedure airway assessment aids in management of the airway if respiratory depression occurs, including identification of the need for increased expertise in airway management for patients at higher risk.
Complete a visual airway inspection to identify potential risk factors in managing the patient's airway. This includes identifying the presence of loose teeth, dentures, assessing the patient's neck (chin to chest flexion and hyperextension) and jaw mobility (ability to open their mouth). Review the patient's history for factors contributing to the risk of airway maintenance such as head and neck surgery, obesity, cervical stenosis, arthritis, injury, etc.
** NPO Status
Gastric emptying is influenced by many factors including anxiety, pain, abnormal function (e.g., diabetes), pregnancy, and mechanical obstruction. Therefore, following an NPO protocol does not guarantee that complete gastric emptying has occurred.
Adults must fast from solids and non-clear liquids for 6-8 hours prior to a scheduled procedure requiring sedation and from clear liquids for 2-3 hours. This includes enteral nutrition given by feeding tube.
Procedure specific fasting protocols may exceed these recommendations and should be referred to for optimal patient care.
Patients administered oral contrast for a diagnostic study should not be considered to have an empty stomach. Thus the risk of vomiting and aspiration in a sedated patient with oral contrast is higher than for patients with an empty stomach. All attempts must be made to perform these procedures under the "lightest" sedation possible.
A qualified RN will educate the patient and/or family prior to administration of sedative medication regarding the risks/benefits/options of the recommended procedure, use of sedative drugs related to the procedure/treatment and any alternatives. Include information about what the patient can anticipate before, during and after sedation including symptoms and side effects to report. When possible, work out a pre-established signaling system for pain. Where applicable, pre-sedation instruction will be given to the patient, i.e., medication adjustments, NPO requirements, designated driver post procedure, etc. This will be performed by a qualified RN.
4. Obtain Informed Consent
Discuss the risks, benefits and alternatives to the procedure, with and without sedation, with the patient and/or family members as appropriate. Include post procedural expectations such as management of any post procedure pain and anticipated short and long term changes in activities of daily living. Ensure that patients or legal surrogates understand the proposed treatment and its potential complications. Ask each patient or legal surrogate to recount what he or she has been told during the informed consent. (Leapfrog) By providing pre-procedure patient education, the physician can allay patient fears and anxiety regarding the planned procedure. These measures can lead to a decrease in the dosage of medications needed for sedation (Yaney, 1998).
Document consent as outlined in hospital policy 4.17 Informed Consent including date and time consent was obtained. The following outlines the various categories of medical care and the corresponding documentation required for each category, as it relates to sedation:
Signed consent generally means a consent form or statement signed by the patient or representative. It is required for:
- All procedures performed in an operating room, which includes procedures performed with sedation or anesthesia; and
- All other operative and diagnostic procedures requiring anesthesiology services regardless of location (excluding PICC lines as per policy 4.17, Informed consent)
Documented consent includes signed consent (see above) or a note included in the patient chart outlining risks/benefits/alternatives to the plan of care. It should be signed by the responsible physician and note that the patient/representative understands and agrees to proceed with the plan as discussed. It includes:
- All other invasive procedures (except for minimally invasive procedures with minimum risk) not included above, and
- Procedures involving moderate sedation.
In an emergency, when the patient is unable to give consent and delaying medical care until a patient's authorized representative can be found risks serious injury to health or significant pain, medical care may be given to the extent needed to respond to the emergency needs of the patient, provided there is no known advance directive to the contrary. In case of doubt concerning the validity or applicability of an advance directive directing withholding treatment, emergency medical care should be given. When possible, attempts to obtain consent of the patient or the patient's authorized representative should continue while care is given. The responsible physician determines the existence of an emergency. It is advisable to document in the medical record the nature of the emergency and the efforts made to obtain consent.
No patient shall receive sedation until a pre-sedation assessment has been completed and documented by the physician responsible for the sedation. Documentation includes the patient's appropriateness to receive sedation.
The person administering the sedation medication (generally the qualified RN) is responsible for assuring the requirements are completed before administering medication. A procedure will be delayed or cancelled until all pre-procedure documentation is complete. This includes:
- Informed consent
- History and physical
- Physician attestation statement of appropriateness
5. Establish Venous Access
Establish venous access, if appropriate, for the administration of intravenous sedation and ready access should additional medications or IV fluids required during or after the procedure. The responsible physician determines the need for venous access.
6. Obtain Necessary Equipment
Because the potential for respiratory depression exists, resuscitative equipment needs to be readily available. Allow time for and coordinate equipment availability and set-up with nursing staff. A qualified RN will determine that the following resuscitative and monitoring equipment are available:
- Suction apparatus with appropriate suction catheters
- Oxygen delivery system capable of 15 L/min flow for greater than 60 minutes
- Appropriately sized masks and oral and nasal airways
- Resuscitation bag
- Pulse oximeter and blood pressure monitoring equipment
- Emergency medications including reversal agents, and
- ECG monitor where appropriate (patient at risk for cardiac arrhythmia and/or ischemia)