MANAGING THE RISKS OF PROCEDURAL SEDATION · Procedures in the emergency department. Minimal sedation (anxiolysis) Moderate sedation (conscious sedation) Deep sedation/ analgesia

MANAGING THE RISKS OF PROCEDURAL SEDATION

Procedural sedation: What are the risks? While procedural sedation is beneficial to the patient and also helps clinicians effectively perform procedures, there are significant risks involved. Patients are at risk of respiratory depression, which can lead to significant injury or even death. Patients may have apneas or airway obstruction due to sedation depth. And oversedation can lead to slower recovery time and increased hospital length of stay.

Multiple factors contribute to an increased risk of adverse events during procedural sedation, including:

■ Patient’s overall health and comorbidities

■ Experience and comfort level of anesthesia provider

Procedural sedation is used during most minimally invasive procedures that do not require general anesthesia, including:

■ Gastrointestinal (GI) procedures or endoscopy

■ Cardiac catheterization lab procedures

■ Interventional radiology procedures

■ Procedures in the emergency department

Minimal sedation (anxiolysis)

Moderate sedation (conscious sedation)

Deep sedation/ analgesia

General anesthesia

Responsiveness Normal response to verbal stimulation

Purposeful response to verbal or tactile stimulation

Purposeful response following repeated or painful stimulation

Unarousable, even with painful stimulus

Airway Unaffected No intervention required

Intervention may be required

Intervention often required

Spontaneous ventilation Unaffected Adequate May be inadequate Frequently inadequate

Cardiovascular function Unaffected Usually maintained Usually maintained May be impaired

Sedation is a continuum and patient response is unpredictable

VITAL INFORMATION

A patient storyA 55-year-old woman, in good health, entered a medical facility for an elective endoscopic retrograde cholangiopancreatography (ERCP) with transduodenal papillotomy. She was monitored continuously with pulse oximetry (SpO2), ECG and NIBP. The patient received 4 liters per minute of supplemental O2 through nasal cannula and was given midazolam 2+ 1 mg ev, propofol 30 mg iv followed by a continuous infusion of propofol 2 mg/kg/h for sedation.

Healthy patient entered hospital for elective procedure

After 20 minutes, the NIBP monitoring indicated low blood pressure; progressively within a few seconds, the SpO2 decreased from 96% to 65%; the HR, which had been stable at 125 bpm, rose to 135 bpm

After further evaluation, the patient was intubated and transferred to ICU

The following day, a cerebral CT scan evidenced a severe anoxic-ischemic damage

Within 3 days of the event, death was assessed

What happened is easily explained by an arrest of spontaneous ventilation resulting from accumulation of sedative drugs, or an obstruction of the upper airway resulting in lack of O2 inhalation/absorption even though provided by the supplemental nasal cannula, or even the summation of the two mechanisms.

In all likelihood, during the procedure the patient experienced hypoventilation due to the summation of several factors, and the enrichment of the inhaled air prevented the onset of hypoxia that accompanies physiological states of hypercapnia and hypoventilation in ambient air.

Clinical studies show that capnography, a noninvasive measurement of exhaled carbon dioxide and the earliest indicator of ventilatory status, reduces the number and duration of hypoxic events in patients undergoing procedures with sedation.9-10

CLINICALLY PROVEN

Numerous clinical studies have evaluated the utility of capnographic monitoring in reducing the incidence of respiratory depression and hypoxemia during procedural sedation for endoscopic procedures.

Compelling Clinical Evidence PubMed Link

Does end-tidal carbon dioxide monitoring detect respiratory events prior to current sedation monitoring practices? Burton JH, Harrah JD, Germann CA, Dillon DC. Acad Emerg Med. 2006;13(5):500-504.

www.ncbi.nlm.nih.gov/pubmed/16569750

Does end-tidal CO2 monitoring during emergency department procedural sedation and analgesia with propofol decrease the incidence of hypoxic events? A randomized, controlled trial. ACEM. 2009.

www.ncbi.nlm.nih.gov/pubmed/21111255

Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, et al. Gastroenterol. 2009;136(5):1568-1576.

www.ncbi.nlm.nih.gov/pubmed/19422079

Capnography enhances surveillance of respiratory events during procedural sedation: a meta-analysis. Jonathan B. Waugh PhD, J Clin Anesth. 2011.

www.ncbi.nlm.nih.gov/pubmed/21497076

Capnographic monitoring reduces the incidence of arterial oxygen desaturation and hypoxemia during Propofol sedation for colonoscopy: a randomized, controlled study (ColoCap study). Beitz A, Riphaus A, Meining A, Kronshage T, Geist C, Wagenpfeil S, et al. Am J Gastroenterol. 2012;107(8):1205-1212.

www.ncbi.nlm.nih.gov/pubmed/22641306

What capnography providesCapnography is a noninvasive, continuous measurement of carbon dioxide during the respiratory cycle as a function of time. It provides critical patient information:

■ The earliest indicator of hypoventilation, airway obstruction, no breathing

■ Monitors potential risk of oversedation more effectively than pulse oximetry alone

■ Validates breathing and airway integrity (waveform shape)

■ Accurately monitors respiration rate

Apneic Waveform

CAPNOGRAPHY IS RECOMMENDED

Over the last four years, 29 statements worldwide have identified capnography as a tool for managing the risk of respiratory compromise. The European Board of Anaesthesiology (EBA) recently released the latest additions to a growing list of society guidelines identifying capnography as a way to improve patient safety.

Society Recommendation

Academy of Royal Medical Colleges1 “Where not already in use, as a fundamental standard, capnography for patients receiving sedation should be considered a Developmental Standard.”

American Society for Gastrointestinal Endoscopy2

“Extended monitoring with capnography should be considered as it may decrease the risks during deep sedation.”

American Society of Anesthesiologists3 “During moderate or deep sedation the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide unless precluded or invalidated by the nature of the patient, procedure, or equipment.”

Association of Anesthetists of Great Britain and Ireland4

“It is also recommended that continuous capnography should be considered during sedation for all patients receiving deep sedation and for all patients receiving moderate sedation whose ventilation cannot be directly observed.”

British Royal College of Anaesthestists/British Society of Gastroenterology5

“Monitoring of respiration with continuous waveform capnography is also recommended for all sedated patients and is essential for those whose ventilation cannot be directly observed. Such monitoring devices are now widely available and should be used for patients receiving propofol sedation for ERCP.”

Canadian Anesthesiologist Society6 “Recommend[s] that capnography monitoring be utilized in all patients undergoing general anesthesia and deeper levels of sedation.”

European Board of Anaesthesiology7 “All patients undergoing moderate or deep sedation should be monitored with continuous capnography.”

The Spanish Society of GastrointestinalEndoscopy8

“Capnography may be useful in seriously ill patients with multiple conditions who will undergo long-term sedation for prolonged or complex endoscopy procedures (ERCP, prosthesis placement, etc.). This monitorization measures ventilatory activity, and predicts potential respiratory depression before the pulse oximeter may detect desaturation.”

UNIQUE OPTIONS

Why Microstream™ capnography from Medtronic?For decades, clinicians have relied on Microstream™ technology to monitor patients’ CO2 waveforms and end-tidal CO2 (etCO2) and alert them to early indications of evolving respiratory compromise.

Microstream™ waveform capnography provides an accurate, reliable and easy-to-use assessment of a patient’s ventilatory status. Available in a wide range of patient monitors and devices, Microstream™ capnography delivers the following clinical benefits:

■ Revolutionary Detection Technology: Unique CO2-specific molecular correlation spectroscopy (MSC) measurement technology is unaffected by the presence of other gases such as, O2, N2O, He or inhaled anesthetics.

■ Smart Capnography™ algorithms: A suite of decision support algorithms proven to simplify the use of capnography monitoring, including:

– Smart Breath Detection™ algorithm (SBD): Reduces low amplitude “non-breath” CO2 waveform excursions like talking, crying or snoring to provide a more accurate respiratory rate.

– Smart Alarm for Respiratory Analysis™ algorithm (SARA): Functioning in combination with the SBD algorithm, the SARA algorithm is proven to reduce clinically insignificant respiratory rate alarms.

– Integrated Pulmonary Index (IPI): Provides the only integrated measure of a patient’s adequacy of ventilation and oxygenation. This algorithm utilizes real-time measures and interactions of four parameters; etCO2, RR, pulse rate and SpO2 into a single 1–10 index.

– Apnea-Sat Alert (ASA): Apnea-Sat Alert provides an automated method of tracking recurring apnea and oxygen desaturation events anytime the patient is being monitored over one hour.

Capnostream™ 20p bedside monitorThe Capnostream™ 20p bedside monitor is built on a legacy of proven performance. Clinicians rely on Microstream™ technology for an accurate, continuous view of ventilation adequacy on intubated and nonintubated patients, from neonate to adult. The new Capnostream™ 20p bedside monitor reveals a more complete picture of your patient’s respiratory status.

Microstream™ capnography is integration capableMicrostream™ capnography can also be integrated into a host of multiparameter monitors. Please see our latest brochure for more details on compatibility with OEM partners.

QUALITY SAMPLING

Quality sampling lines from MedtronicA key to obtaining an accurate etCO2 measurement and quality CO2 waveforms with any capnograph is the sampling line. Measurement technology can only report what is being delivered, so if the sampling line is not providing a representative CO2 sample, the accuracy of the measurement is impacted.

Medtronic offers a range of sampling lines for various patient populations and procedures. The Smart CapnoLine™ sampling line is ideal for procedural sedation as it was engineered to obtain a quality sample whether the patient is breathing from one or both nares, orally or switching back and forth between nasal and oral breathing. It also delivers oxygen through production of an “oxygen cloud” through the nasal cannula.

Oridion

31.93

20.3518.25

16.2913.88

32.45

Room Air

35

30

25

20

15

10

5

0O 2 l/m

Salter

GE

mm

Mer

cury

Figure 1: Mouth Breathing etCO2 Measurement

0.38

0.36

0.34

0.32

0.30

0.28

0.26

P=0.049

SmartCapnoLine

Split Cannula

F iO2

Pharyngeal FiO2 at 2.5 LPM Flow (shown Mean ± 95%CI).

Smart CapnoLine

Split Cannula

Range Mean ± 95% CI

“Expected 0.285” value from calculation

Figure 2: FiO2 Consistency During O2 Delivery at 2.5 lpm. Derived from Schacter et al, Crit Care Med 1980 – as used in Egan, Fundamentals of Respiratory Care 6th Ed.

Oxygen deliveryThe Smart CapnoLine™ sampling line is designed to deliver oxygen through the production of an “oxygen cloud” in front of the nose and mouth. This is achieved with a series of small holes at the base of the nasal prongs and oral scoop that deliver oxygen. This design is also intended to minimize attenuation of the CO2 sample by oxygen dilution.

C02 sampling

02 flow

SMART CAPNOLINE™ PLUS O2 SAMPLING LINE

The Smart CapnoLine™ plus O2 sampling line monitors patients’ CO2 for immediate notification of respiratory complications including: airway obstruction, hypoventilation or shallow breathing. Used for lower gastrointestinal procedures, electrophysiology labs, cardiac cath labs and interventional radiology sedation, the system also provides O2 delivery during the procedures.

The system offers a 4 m CO2 line which is often needed in sedation areas. It conveniently can be sold with O2 connector or O2 tubing attached.

Smart CapnoLine™ plus O2 sampling lines are recommended for lower gastrointestinal procedures, electrophysiology labs, cardiac cath labs and interventional radiology sedation.

0.2 micron FilterSterilizing grade filter designed to reduce risk of biohazard contamination of the monitor

Uni-junction™ TechnologyEnables etCO2 sampling from either the nares or the mouth

Oral ScoopProvides accurate sampling for mouth breathers

SMART CAPNOLINE™ O2 SAMPLING LINE WITH GUARDIAN BITE BLOCK

The Smart CapnoLine™ O2 sampling line with Guardian bite block is designed to capture CO2 samples and deliver supplemental oxygen during upper endoscopy procedures or any procedure when a bite block is required. The system enhances patient safety during sedation with oral and nasal CO2 ventilation monitoring, during and after the procedure. The combined CO2 sampling and O2 delivery line fits into the bite block to protect delicate endoscopy devices from damage.

Smart CapnoLine™ sampling lines are recommended for upper endoscopy procedures or any procedure when a bite block is required.

High flow oral and nasal O2 delivery — up to 10 lpm — during the procedure and nasal O2 delivery after the procedure

Combined etCO2 sampling and O2 delivery line fits into the bite block

Shields 60 French endoscopic equipment with a high maneuverability bite block

Product recommendations for Microstream™ capnography during procedural sedation

Upper procedures

■ EGD (Esophagogastroduodenoscopy)

■ EUS (Endoscopic ultrasound) ■ ERCP (Endoscopic retrograde

cholangiopancreatography)

Smart CapnoLine™ O2 sampling line with Guardian bite block

■ Bronchoscopy If oral approach use:Smart CapnoLine™ O2 sampling line with Guardian bite block

If nasal approach use:Smart CapnoLine™ Plus O2 sampling line

Lower procedures

■ Colonoscopy ■ Flexible Sigmoidoscopy (no

sedation)

Smart CapnoLine™ Plus O2 sampling line with Guardian bite block

Other ■ Bronchoscopy Smart CapnoLine™ Plus O2 sampling line with Guardian bite block

Procedural sedationoutside GI lab

■ Cardiac Cath Lab ■ EP (Electrophysiology lab) ■ ED (Emergency Department) ■ Interventional Radiology

Smart CapnoLine™ Plus O2 sampling line

■ TEE (Transesophageal echocardiogram)

■ Bronchoscopy

Smart CapnoLine™ O2 sampling line with Guardian bite block

1. Safe sedation practice for healthcare procedures: standards and guidance. Academy of Medical Royal Colleges. October 2013. http://www.aomrc.org.uk/doc_view/9737-safe-sedation-practice-for-healthcare-procedures-standards-and-guidance. Accessed 2014.

2. Faigel DO, Baron TH, Goldstein JL, et al. Guidelines for the use of deep sedation and anesthesia for GI endoscopy. Gastrointest Endosc. 2002;56(5):613-617.

3. American Society of Anesthesiologists. Standards for Basic Anesthetic Monitoring (Approved by the ASA House of Delegates on October 21, 1986, and last amended on October 20, 2010, with an effective date of July 1, 2011).

4. Capnography outside the operating theatre. AAGBI Safety Statement 2009. Association of Anaesthetists of Great Britain & Ireland. http://www.aagbi.org/sites/default/files/AAGBI%20SAFETY%20STATEMENT_0.pdf.

5. Guidance for the use of propofol sedation for adult patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) and other complex upper GI endoscopic procedures. Royal College of Anesthetists. March 2014. http://www.rcoa.ac.uk/system/files/PROPOFOL-ERCP-2014.pdf.

6. Merchant R, Chartrand D, Dain S, et al. Guidelines to the practice of anesthesia revised edition 2012. Can J Anaesth. 2012;59(1):63-102.

7. EBA recommendation for the use of capnography. European Section and Board of Anaesthesiology. 2011. http://www.eba-uems.eu/resources/PDFS/EBA-UEMS-recommendation-for-use-of-capnography.pdf

8. Lopez Roses L, Subcomite de Protocolos of the Spanish Society of Gastrointestinal Endoscopy S. Sedation/analgesia guidelines for endoscopy. Rev Esp Enferm Dig. 2006;98(9):685-692.

9. Beitz A, Riphaus A, Meining A, et al. Capnographic monitoring reduces the incidence of arterial oxygen desaturation and hypoxemia during propofol sedation for colonoscopy: a randomized, controlled study. Am J Gastroenterol. 2012;107(8):1205-1212.

10. Friedrich-Rust M, Welte M, Welte C, et al. Capnographic monitoring of propofol-based sedation during colonoscopy. Endoscopy. 2014;46:236-244.

REFERENCES

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