PainNCT03968094
Early Detection of Respiratory Compromise to Prevent Harm of the Hospitalized Opioid Treated Patient
An observational study of Pain, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults undergoing elective surgery of the abdomen, limbs, back.
Who may be able to join
None listed.
Who cannot join
- Oxygen Dependent (wears supplemental oxygen at home)
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo General Medical Center
Buffalo, New York, 14203
About this study
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.
Read the detailed 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.
- Conditions
- Pain
- Keywords
- Respiratory Compromise
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Induced Respiratory Depression
Electronic Respiratory Data
Measured: 48 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jun 2019
- Primary completion30 Mar 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Jungquist, State University of New York at Buffalo
- Investigators
- Carla Jungquist, PhD, ANP, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968094
- Sponsor's protocol ID
- MOD00005932
- Status last verified
- Nov 2020
- First submitted
- 28 May 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Respiratory Compromise to Prevent Harm of the Hospitalized Opioid Treated Patient
- ClinicalTrials.gov ID
- NCT03968094
- Acronym / sponsor ID
- MOD00005932
- Conditions
- Pain
- Keywords
- Respiratory Compromise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing elective surgery of the abdomen, limbs, back.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Oxygen Dependent (wears supplemental oxygen at home)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opioid Induced Respiratory Depression
Time frame: 48 hours post-operative
Electronic Respiratory Data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Jungquist, PhD, ANP principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Induced Respiratory Depression (time frame: 48 hours post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.