EMS agencies annually transport and provide care to approximately 481,600 patients in Colorado. Of these, about 20% are trauma-injured, 72% have medical/behavioral or other conditions, and 8% have unknown injuries. There are 205 licensed ground ambulance agencies, 31 licensed and recognized air ambulance agencies, and approximately 19,500 certified and licensed EMS providers in Colorado.
CDPHE does not license ground ambulance agencies; however, several state laws require that all licensed ambulance agencies (both ground and air) submit patient care data to CDPHE.[15] Unlicensed EMS agencies are not required to submit ePCRs but, if their medical directors have scope of practice waivers, they are required to submit data to the state waiver reporting system.
Current regulations specify that patient care data be submitted as defined in the National Highway Traffic Safety Administration’s (NHTSA) Office of Emergency Medical Services, NEMSIS Data Dictionary NHTSA Version 3.4.0, EMS Data Standard, published on July 13, 2016 (NEMSIS 3.4.0).[16] NEMSIS is a national repository for patient care data; it also sets national standards for the 270 data elements that are collected. The NEMSIS data set was designed for two purposes: 1) to improve patient care through the standardization, aggregation, and utilization of point of care EMS data at a local, state, and national level, and 2) to enable formal research and analysis of the data.
In contrast to the 270 data elements collected by the federal NEMSIS reporting system, the state waiver reporting form contains 40 data elements that were selected by EMPAC and CDPHE.[17] The intent of the state’s waiver data collection is to evaluate the impact of the waivered medication on the health, safety and welfare of the patient, monitor general trends, and identify incidences for review on a case-by-case basis. It is neither intended to evaluate the overall quality of care provided to the patient nor to conduct formal research. Another important limitation of this data set is that it does not establish a causal link between the medication and complications or outcomes. CDPHE must often take the additional step of trying to link the waiver data to ePCR data in order to conduct a more robust evaluation of information on the severity of incidents.
CDPHE compiles and analyzes waiver data and presents aggregate statistics to EMPAC annually. Information concerning 2019 data, the most recent data that has been compiled and analyzed by CDPHE, was also presented to the panel.[18] (See Appendix E)
- 97 Colorado EMS agencies had waivers to administer ketamine for excited delirium and/or extreme or profound agitation;
- 31 agencies reported using ketamine for this condition;
- A total of 1,820 waivered ketamine incidents were reported: 1,366 were for pain and 454 for excited delirium and/or extreme or profound agitation; in 70% of cases, the suspected cause of the excited delirium was classified as psychiatric/behavioral;
- 78% of ketamine doses were administered to men; and
- 64% of persons who received ketamine were 20-39 years of age.
CDPHE staff provided the following data on complications associated with ketamine use for excited delirium and/or extreme or profound agitation. Of the 454 incidents reported, 109 incidents, or 24%, reported some type of complication (Table 2). Complications reported included apnea, bradycardia, hypoxia, medication side effects, hypotension, cardiac arrest, laryngospasm, and “others.”[19] Hypoxia, apnea, and “other” were the most frequent complications. When reviewing data concerning complications, it is important to remember that these events do not necessarily represent an error or defect related to a medication administration. Complications are in most cases predictable medication side effects for which monitoring and mitigation are necessary.
Colorado Data on Complications from Ketamine for ExDS
| Complication Reported | Count | Percent |
| Apnea✝ | 16 | 4% |
| Bradycardia | * | * |
| Laryngospasm | * | * |
| Hypoxia‡ | 73[20] | 16% |
| Hypotension | 3 | 1% |
| Medication Side Effects | 6 | 1% |
| Other | 34 | 7% |
| Cardiac Arrest | * | * |
✝ 9 incidents with ePCRs indicating > 6 breaths/min
*= Low counts were suppressed to protect patient confidentiality. Low count = <2.
‡ 35 incidents with ePCRs indicating SpO2>90%
CDPHE staff also undertook a quality improvement review of the data on complications for two purposes: 1) to assist in understanding the severity of the incidents with complications, and 2) to assess data integrity. For each waiver report indicating a complication, staff linked the waiver report submitted to CDPHE with the corresponding EMS electronic Patient Care Report (ePCR) submitted by the EMS agency. These records were linked based on: Incident Date, Agency Name, Destination Facility, and Patient Age and/or Gender. The EMS ePCRs were then reviewed by two sets of reviewers for specific metrics to gather more information about the severity of the complication, interventions that took place, and final patient acuity. The results of this QI chart review were shared with the KIRP.
Hypoxia, meaning a reduction in the amount of oxygen carried in the blood, is a common complication of many sedative or analgesic medications. The chart review found that there were no uniform criteria applied by EMS providers to define “hypoxia,” resulting in inconsistent reporting of the condition. Hypoxia is a condition in which the body is deprived of adequate oxygen supply which, depending on the patient, may occur at a peripheral capillary oxygen saturation (Sp02) below 90%. However, 48% of those classified as hypoxic in the waiver data set had oxygen levels that exceeded that level (i.e., Sp02 > 90%). Across several of these categories of complications, further assessment found many complications were mild and temporary: the chart review suggested that 10.4% of the 454 cases experienced a meaningful complication during transport.[21]
Intubation involves the insertion of a tube (endotracheal tube) down the throat and into the trachea to get air into and out of the lungs. It is performed to support someone with their breathing if they are not breathing well on their own, a complication that sometimes occurs following administration of sedatives and strong analgesics. It is a lifesaving measure when a patient’s airway is compromised, but is not without risk and potential complications, which include but are not limited to lung and hemodynamic (blood pressure) collapse and damage to the trachea and throat. Of the 454 uses of ketamine in 2019, 10 (2%) were intubated in the prehospital setting and 35 (7.7%) intubations were initiated at the hospital. The dissociative properties of ketamine (discussed later) can make a patient non-responsive (albeit with frequently maintained ventilation and airway reflexes) which, in the hands of a provider who is unfamiliar with this consequence, may lead to intubation rather than simply monitoring the patient’s airway. It should be noted that many of these cases may require intubation for airway protection due to underlying drug and alcohol intoxication rather than as a consequence of ketamine. It is impossible to tease out the root cause of respiratory arrest in these situations.
Dr. Whitney Barrett advised the panel about Denver Health Paramedic Division’s (DHPD) experience with ketamine administration for the time period from August 2017 to the present. Dr. Barrett provided the panel members with information concerning how DHPD’s rate of ketamine administration in Denver compared to its administration of other sedative drugs such as midazolam and haloperidol. The DHPD data show that ketamine has been used significantly less frequently than other chemical restraints. (See Appendix C)