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NCT03968094 · ClinicalTrials.gov registry record
Early Detection of Respiratory Compromise to Prevent Harm of the Hospitalized Opioid Treated Patient
A clinical trial, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- 47
- Enrollment target
NCT03968094: Completed study, sponsored by State University of New York at Buffalo.
NCT03968094 is a clinical trial that has completed, run by State University of New York at Buffalo. The registered enrollment target is 47 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03968094 has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- 47 participants
- Enrollment target
Study 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
Primary Outcome
Electronic Respiratory Data
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2020-09-01 |
What the finished NCT03968094 record still lists
NCT03968094 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 47 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03968094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03968094 about?
NCT03968094 is a clinical study titled "Early Detection of Respiratory Compromise to Prevent Harm of the Hospitalized Opioid Treated Patient". 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 compromis...
What is the current status of trial NCT03968094?
This trial is currently completed. The enrollment target is 47 participants. The study started on 2019-06-01. Estimated completion is 2020-09-01.
Who is sponsoring clinical trial NCT03968094?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
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