Incidence of Opioid-Induced Respiratory Depression in Medical and Trauma Patients

Study Overview
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Brief Summary
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The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous (IV) opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.

Official Title
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Incidence of Opioid-induced Respiratory Depression in Medical and Trauma Patients on the General Care Floor Receiving Patient-controlled Analgesia and Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study

Conditions
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Respiratory Depression, Sedation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spontaneously breathing adults 18 to 89 years of age English speaking Receiving PCA or nurse administered IV opioids for medical or trauma-related pain Admitted to the general care floor from the emergency department Exclusion Criteria: Less than 18 or greater than 89 years of age Transfer to the general care floor from the Intensive Care Unit Receiving intrathecal or epidural opioids Inability or unwillingness to wear the etCO2 sampling line nasal cannula or pulse oximetry sensor History or diagnosis of a sleep disordered breathing syndrome Use of Continuous Positive Airway Pressure or (CPAP) or Bilevel Positive Airway Pressure (BIPAP) non-invasive ventilation as home regime Receiving non-invasive ventilation Presence of a co-morbidity that impacts respiration or ventilation (e.g Chronic Obstructive Pulmonary Disease or Pulmonary Fibrosis) Unwilling or unable to participate Member of a vulnerable population such as pregnant women or prisoners.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoventilation | Continuous respiratory monitoring using capnography will be performed for collecting data of end-tidal carbon dioxide (etCO2) | Change from baseline measurement observed within 60 minutes after opioid administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Continuous respiratory monitoring using pulse oximetry will be performed for collecting data of oxygen saturation (SpO2) | Change from baseline measurement observed within 60 minutes after opioid administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory depression, opioid-induced sedation