Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03968094 |
| Other study ID # |
MOD00005932 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
September 1, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
State University of New York at Buffalo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Imagine a hospital or ambulatory surgical work environment where clinicians could look at an
electronic respiratory monitoring device and observe the patient's data over time, and be
cued by the monitor before the patient exhibits dangerous opioid induced respiratory
depression/respiratory compromise. Currently, clinicians use electronic monitoring data for
real-time assessment of respiratory status. Alarms set at thresholds alert a clinician when
the patient is currently experiencing respiratory compromise. Adverse events secondary to
opioid induced respiratory compromise (OIRC) continue to occur in 0.5-4.2% of hospitalized
patients receiving opioids for acute pain. Opioids continue to be a staple for acute pain
management. In this environment of litigation around adequate pain management and the use of
opioids, clinicians need a more sensitive and specific way to determine which patients are at
risk of severe respiratory depression when using opioids for acute pain management in the
hospital setting.
This study proposes to evaluate algorithms preliminarily developed in the computer
laboratory. This translational research will compare and test replication of our algorithms
in a new sample of patients. Patients' electronic monitor data will be used to further
develop our algorithms for identifying patients who exhibit OIRC and predicting OIRC events.
Explicitly, we will monitor post-operative patients using pulse oximetry, capnography, minute
ventilation, and transcutaneous PCO2 during recovery from anesthesia (in PACU), and on the
general care floor for up to 72 hours. This data, along with covariates collected from the
electronic medical record and environment will be used in machine learning models to develop
our algorithms in an iterative process. Future studies will involve instituting these
algorithms into a monitoring interface and testing in simulation and in real-time on
patients. Please see AHRQ summary sheets from a submission that occurred earlier this year.
Description:
Setting: This research project will be performed at an inner-city hospital in Western New
York, Buffalo General Medical Center (BGMC) is typical of an under-resourced facility
providing care to a substantial proportion of the indigent, minority, immigrant and medically
underserved population of a region. In 2017, 36% of BGMC patients identified themselves as
Black or African American. Typical patients face economic, cultural or linguistic barriers to
healthcare. By focusing on OIRC at BGMC, this study will help in informing how health
disparities may impact the incidence of OIRC. At BGMC in 2017, 11,744 surgical procedures
were performed and 2% of general surgical cases experienced an adverse event (code blue).
Information on adverse events related to OIRC is not available.
Aim 1. After recruiting and performing informed consent pre-operatively, we will monitor
post-operative patients using pulse oximetry, capnography, TCpCO2, and minute ventilation
during recovery from anesthesia (in PACU), and on the general care floor for up to 72 hours.
An observational study of 50 surgical patients will be performed to record electronic
respiratory monitoring data as well as patient characteristics. This information will be used
for validation and iterative development of prediction models using machine learning
techniques. In our preliminary work, we used data that was collected by the research
assistants reading the data off the device display. During the proposal proposed study, we
will record the data from each electronic device directly on USB memory sticks attached to
the device. In our preliminary work, we had data from the PACU stay only. During this study,
we will collect data prospectively throughout the hospital stay to further inform changes in
respiratory compromise as the patient transitions away from the anesthetic and paralytic
agents . On the machine learning side, we will explore long-short term memory networks
(LSTM), which have become the state of art machine learning models to deal with sequence and
time series data (24), including applications in the healthcare domain (25), including recent
work by Co-I Chandola. The justification behind using these models over the support vector
machine model used in our preliminary study is that they are able to explicitly model the
temporal dependencies in the data, which is expected to provide significant improvements in
the predictive performance of the model (26).
Aim 2. To further understand factors related to OIRC and to assist in responding to the AHRQ
reviewers' comments, we will perform a root cause analysis of all adverse events found in the
patients we recruited for Aim 1, as well as all rapid response calls, naloxone deliveries,
and code blue calls for 2018 at Buffalo General Medical Center (BGMC ). We will examine each
case specifically for nursing assessment and monitoring procedures as well as all patient and
environmental factors that may have contributed to the adverse event. The patient safety
physician and quality assurance nurses from BGMC will be interviewed to perform root cause
analysis of all opioid-related adverse events that have occurred over the past year at the
facility. Each event will be broken down by who was involved, what they were doing, what
technologies were used, where did the event take place, and what outside factors may have
contributed to the event. This information will be used to group the potential causes and the
progression toward the adverse event, which will allow for identification of the roles of
staff workload and patient monitoring on OIRC occurrence. We have received a letter of
support from the medical director of patient safety at BGMC and Kaleida Health chief nursing
office for our intended projects.
