Transcript GHP Moderate sedation 2009 Final

Guidelines for the Care of
Patients undergoing Moderate or
Procedural Sedation
The Medical City
Good Hospital Practice Training Series 2009
Outline of presentation
• Policy statement and purpose
• Definitions, levels of sedation and anesthesia
• Qualifications and roles of physician and
assistant
• Mandatory equipment
• Responsibilities
• Patient selection criteria
• Pre-, intra- and post-procedure assessment and
care
• Discharge criteria
• Documentation and outcomes measurement
Policy Statement
• Sedation administered to inpatients and to
outpatients shall be carried out to provide
the best clinical conditions while
performing a diagnostic, therapeutic or
surgical procedures insuring that the
patient’s well being is safeguarded at all
times.
Purpose
• To establish appropriate guidelines for the
safe use of medications that alters a
patient’s state of consciousness.
• These guidelines apply to any setting, for
any purpose, by any route, when a patient
receives medication that alters their state
of consciousness.
Definitions
• Procedural sedation/analgesia is the
proper administration of drugs to obtund,
dull, or reduce the intensity of pain or
awareness.
• The administration of these drugs by any
route carries the risk of loss of protective
reflexes.
Levels of Sedation
and Anesthesia
Minimal sedation (Anxiolysis) : a drug
induced state during which patients
respond normally to verbal commands.
– Although cognitive function and coordination
may
be
impaired,
ventilatory
and
cardiovascular functions are unaffected.
Levels of Sedation
and Anesthesia
Moderate sedation/ Analgesia (Conscious
sedation): A drug-induced depression of
consciousness during which the patients
respond purposefully to verbal commands,
either alone or accompanied by light tactile
stimulation.
- No interventions are required to maintain a patent
airway, and spontaneous ventilation is adequate.
- Cardiovasular function is usually maintained.
Levels of Sedation
and Anesthesia
 Deep Sedation/Analgesia: A drug-induced depression
of consciousness during which patients cannot be easily
aroused but respond purposefully following repeated or
painful stimulation.
-The ability to independently maintain ventilatory function may be
impaired.
-Patients may require assistance in maintaining a patent airway
and spontaneous ventilation may be inadequate.
-Cardiovascular function is usually maintained.
Levels of Sedation
and Anesthesia
Anesthesia: Refers to general anesthesia.
-General Anesthesia is a drug-induced loss of consciousness
during which patients are not arousable, even by painful
stimulation.
-The ability to independently maintain ventilatory function is
often impaired.
- Patients often require assistance in maintaining a patent
airway, and positive pressure ventilation may be required
because of a drug-induced depression of neuromuscular
function.
- Cardiovascular function may be impaired.
Exclusion
• Moderate Sedation guidelines do not apply
to the use of sedatives and/or narcotic
agents when used for:
Pain management
Control of seizures
Withdrawal syndromes when individual doses
must be titrated to a
disease specific
response
Sedated patients on a ventilator
Exclusion
• These moderate sedation guidelines apply to
those procedures where moderate sedation is
administered by non-anesthesiologists.
• The same standard of practice applies when
moderate
sedation
is
administered
by
anesthesiologists according to ASA standards.
Personnel Qualifications
and Roles
•
Physician:
The physician must have Advanced Cardiac Life
Support (ACLS) Certification and complete a
course of instruction on sedative medication
usage approved by the Chair of the
Department of Anesthesiology.
The role of the physician is:
1. to prescribe sedation
2. to assure the level of monitoring required in this
policy
3. to manage complications of the sedation
Personnel Qualifications
and Roles
• Physician:
If a patient is deemed as having unusual
airway problems or an ASA PS III or IV
class patient, an anesthesiologist must be
available to ensure adequate airway
management and additional monitoring.
Personnel Qualifications
and Roles
• Assistant:
– An assistant who is BLS certified and has completed
a course of instruction on sedative medication usage
approved by the Chair of the Department of
Anesthesiology shall be present. This assistant will be
privileged for this specific function.
– In the event that the assistant is a technician then a
Registered Nurse (RN) must be readily available to
supervise the assessment and monitoring of the
patient.
Personnel Qualifications
and Roles
• Assistant:
– The role of the assistant is to monitor and record
appropriate physiologic parameters and to assist in
any supportive or resuscitative measures as required
for sedated patients.
– If a patient becomes deeply sedated then one person
(MD, assistant or other) will stop all other duties and
have the sole function of monitoring the patient’s
status, ascertaining airway patency and ventilation,
and documenting vital signs every 5 minutes.
Mandatory Equipment
Immediate access to these equipment is required:
– Cardiac monitor
– Pulse oximeter
– Medications for sedation and reversal of effect
– Blood pressure unit
– Oxygen source and administration equipment
– Bag-valve-mask
– Standard emergency equipment and drugs for
resuscitation
– Defibrillator
– Suction Machine
– Stethoscope
Responsibilities
•
Chairman of the Department of
Anesthesiology and designated Ad
Hoc Team:
a. Are responsible for oversight of the Moderate
Sedation and Anesthesia Care Policy
b. Assure that the Anesthesiology Staff are
available for consultation regarding moderate
sedation and anesthesia care practices
c. Provide training of persons involved in
physiologic monitoring of sedated patients
Responsibilities
•
Unit Managers:
a. Assure that service-specific procedures are
developed for all areas within their service in
which moderate sedation is carried out
b. Provide regular review and appropriate quality
improvement activities with respect to moderate
sedation monitoring and practices
c. Recommends
necessary
credentials
for
privileging of moderate sedation providers within
the service
Responsibilities
•
Medical Staff Providing Sedation or
Anesthesia:
a. Are responsible for overall supervision of the
administration of sedation or anesthesia in
compliance with the policy and procedures
for sedation and anesthesia care
b. Conduct pre-procedural evaluation of the
patient, including the determination that the
patient is an appropriate candidate to
undergo the planned procedure
Responsibilities
•
Medical Staff Providing Sedation or
Anesthesia:
c. Conduct and obtain informed consent
d. Discharge patients from the post-sedation or
post-anesthesia recovery area
e. Insure accuracy and completion of
documentation pre-, intra-, and postsedation management.
Responsibilities
•
Director for Medical Quality
Improvement Office:
a. Is responsible for the overall quality of
sedation and anesthesia care provided to
patients throughout The Medical City
Staffing
•
A minimum of two personnel must be involved
in the care of patients undergoing moderate
sedation during the entire procedure:
1. The physician who performs the
therapeutic or surgical procedure and
diagnostic,
2. The individual whose responsibility is directed only
to the patient: to administer medication, to monitor
the patient, and to observe the patient’s response to
both the sedation and the procedure, under the
supervision of the physician.
Patient Selection Criteria
• ASA guidelines for risk classification are
utilized in the selection of patients to
receive sedation. (Appendix A)
• This policy and procedure is not applicable
to patients in emergent situations.
ASA Physical Status
Classification System
• PS I
a normal healthy patient
• PS II mild to moderate systemic
disease
• PS III severe systemic disease
• PS IV severe systemic disease that is a
constant threat to life
• PS V moribund patient who is not
expected to survive without the operation
• PS VI brain-dead patient
Patient Selection Criteria
1.
2.
3.
4.
The physician scheduling the procedure is responsible
for assigning the patient an ASA classification.
All patients falling into ASA classification I-III are
eligible for moderate sedation.
Patients that meet the criteria for ASA class IV or V
require consultation and/or sedation from a member of
the Department of Anesthesiology.
Ambulatory patients must have competent adult to
escort them home.
Planning For Care
1. Pre-procedure Assessment
The physician will determine the appropriateness of
performing the procedure(s) requiring moderate
sedation based upon:
a. The patient’s medical, anesthetic, and medical
history
b. The patient’s current medical condition
c. Available diagnostic data
d. Risks, benefits and alternatives of the procedure
Planning For Care
2.
Education
Prior to the sedation procedure, the practitioner will
provide the patient/family with information sufficient
to obtain an informed consent which should include
risks, benefits, and alternatives to the procedur .
Age, emotional, safety and psychosocial needs of the
patient will be considered.
All outpatients must be accompanied by a responsible
adult during this process.
Planning For Care
2.
Education
b. Include written discharge instructions to patient and
accompanying adult which include but are not
limited to the following:
B1. should not drive or engage in activities requiring
balance/coordination for up to 24 hours following
the procedure
B2. must have some alternate means of transportation
home;
B3. may experience some dizziness/ balance problems;
B4. Should not drink alcoholic beverages;
PRE-PROCEDURE
1. Validate correct patient using two patient
identifiers: ask patient or guardian name and
date of birth and compare to patient’s medical
record.
2. A comprehensive sedation record shall be
used for documentation and will also serve as
the physician order sheet.
3. The elective patient shall fast for two hours
from clear liquids, six hours from milk and
solids prior to the procedure.
PRE-PROCEDURE
Pre-Induction Assessment
At a minimum, assess and document the following prior to
sedation:
a.
b.
c.
d.
e.
Level of consciousness
Age and weight
Vital signs
Baseline physical assessment
ASA categories 1-5 (see anesthesia/sedation
record)
PRE-PROCEDURE
•
A “time out” should be conducted for
final verification of correct patient,
procedure, site, and as applicable,
implants.
INTRA-PROCEDURE
1. The physician shall be present when
medications to induce sedation are given.
2. During the procedure, and post-procedure, the
healthcare provider monitoring the patient
should have no other responsibilities that
would result in the patient being left
unattended or compromise of monitoring.
INTRA-PROCEDURE
3. Documentation of the following (every 15
minutes or more frequently as dictated by
patient condition during the procedure) on the
anesthesia/sedation record:
a.
b.
c.
d.
e.
f.
Heart rate
Respiratory rate
Pulse oximeter reading
Blood pressure
Responsiveness of the patient/ level of consciousness
Pain level
INTRA-PROCEDURE
4. The patient is monitored for potential adverse
reactions
to
the
medications
being
administered. Any adverse signs or symptoms
are to be reported to the physician immediately
and documented.
Any
actions taken to
correct vital signs deviations during the
procedure should be documented.
5. In the event of a cardio-respiratory arrest the
Code 99 resuscitation protocol will be initiated.
POST-PROCEDURE
1. Patients
receiving sedation are
monitored by a qualified health care
provider until discharged.
2. All vital signs and assessment data will
be documented on the anesthesia/
sedation record every 15 minutes and
PRN (or as determined by the physician).
3. Discharge from the treatment area will be
in accordance with discharge criteria.
POST-PROCEDURE
4. Documentation of sedation should include
•
•
•
•
•
•
•
•
•
Vital signs and post-anesthesia recovery score at or
near pre-sedation level
Pulse oximeter reading at or near pre-sedation level
Patient is alert and easily arousable with protective
reflexes are intact
Nausea, vomiting, dizziness minimal
The patient can talk (if age appropriate)
The patient can sit unaided or lift head from pillow
on command
The state of hydration is adequate
Pain relief is satisfactory
Written discharge instructions provided
CRITERIA FOR TERMINATION
OF MONITORING OF PATIENTS
• Clearance Procedure: Patients will be observed for a
minimum of 45 minutes, with vital signs assessments
taken at 15-minute intervals post-procedure.
– An order for clearance will be written, dated, timed
and signed by the responsible practitioner.
• Monitoring may be terminated when the patient:
– Maintains a patent airway with no evidence of
respiratory depression
– Resumes or maintains baseline Oxygen saturation
– Is fully awake and follows commands appropriately
– Exhibits protective reflexes
– Has baseline/ stable vital signs
– Has minimal discomfort
– Site of invasive procedure is without complication
CRITERIA FOR DISCHARGE
OF OUTPATIENTS
• Outpatients will also meet the following
criteria:
– Ability to ambulate consistent with age/
medical condition
– Minimal nausea
– Minimal discomfort
– Ability to tolerate fluids orally
– Be alert and oriented
– Ability to void voluntarily
CRITERIA FOR DISCHARGE
OF OUTPATIENTS
• Responsible adult will be provided with written
and oral discharge instructions and a phone
number to be called in case of emergency.
• Outpatients must be accompanied by a
responsible adult.
• If the patient does not meet the above criteria, a
decision will be made by the qualified
practitioner to retain the patient in the unit for
further observation or, if necessary, to admit the
patient to an appropriate inpatient unit.
CRITERIA FOR TRANSFER
OF INPATIENTS
• Inpatients may be transferred following
termination of monitoring.
The report
given to the receiving staff will include:
– Procedure performed
– Medication(s) administered
– Vital signs, cardiac rhythm, oxygen saturation
– Patient condition
DOCUMENTATION
• Practitioners will document in the medical
record:
– Procedure performed
– Medications administered
– Complications, if any
– Assessment, vital signs, and other health data
pertinent to pre-, intra-, and post-procedure
– Patient responses to procedure/ medications
– Patient/ family instructions given
PROCESS and OUTCOME
MEASUREMENT
• Any manual intervention on the patient’s
airway
• Any loss of consciousness
• Any prolonged adverse effects of
medications
• Any use of reversal agents
• Any unanticipated hospital admissions
• Any cases in which SpO2 is less than 90%
for 5 minutes, or less than 80% at any time
SUMMARY
• These guidelines apply to patients undergoing
moderate or procedural sedation anywhere in
TMC.
• Only credentialed and privileged MDs and
assists are authorized.
• Only ASA I-III patients can undergo moderate
sedation without anesthesiologists.
• Inpatient standards for pre-, intra- and postprocedure care of patients undergoing moderate
sedation apply. Inpatient documentation and
quality assurance standards also apply.