Early Detection of Respiratory Compromise to Prevent Harm of the Hospitalized Opioid Treated Patient
Public ClinicalTrials.gov record NCT03968094. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03968094
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 47 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 1, 2019 (Actual)
- Primary completion
- Mar 30, 2020 (Actual)
- Completion
- Sep 1, 2020 (Actual)
- Last update posted
- Nov 30, 2020
2019 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Buffalo General Medical Center | Buffalo | New York | 14203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03968094, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 30, 2020 · Synced Oct 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03968094 live on ClinicalTrials.gov.