Incidence OIRD 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 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 OIRD in Medical and Trauma Patients on the General Care Floor Receiving PCA or 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 Receiving PCA or nurse administered IV opioids for medical or trauma-related pain Admitted to the general care floor from the emergency department Able to provide written informed consent Exclusion Criteria: Age is less than 18 years or greater than 89 years Transfer to the general care floor from the ICU Provider order for respiratory monitoring using continuous capnography Receiving intrathecal or epidural opioids Trauma patient with a nerve block 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 CPAP or BIPAP non-invasive ventilation as home regime Pre-existing co-morbidity that impacts respiration or ventilation (e.g. COPD or pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures is not considered having a pre-existing condition) Receiving non-invasive ventilation Unable or unwilling 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 | The number of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection. | Change from baseline measurement observed within 60 minutes after opioid administration | 
| Hypoventilation | The percentage of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection. | Change from baseline measurement observed within 60 minutes after opioid administration | 
| Hypoventilation | The characteristics of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection. | Change from baseline measurement observed within 60 minutes after opioid administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | The number of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection. | Change from baseline measurement observed within 60 minutes after opioid administration ] | 
| Hypoxemia | The percentage of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection. | Change from baseline measurement observed within 60 minutes after opioid administration ] | 
| Hypoxemia | The characteristics of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection. | Change from baseline measurement observed within 60 minutes after opioid administration ] |