Respiratory Depression, Sedation
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
University of California, Los Angeles
Medtronic
Fresno Community Hospital and Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Spontaneously breathing adults 18 to 89 years of age 2. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain 3. Admitted to the general care floor from the emergency department 4. Able to provide written informed consent
Exclusion criteria
1. Age is less than 18 years or greater than 89 years 2. Transfer to the general care floor from the ICU 3. Provider order for respiratory monitoring using continuous capnography 4. Receiving intrathecal or epidural opioids 5. Trauma patient with a nerve block 6. Inability or unwillingness to wear the EtCO2 sampling line nasal cannula or pulse oximetry sensor 7. History or diagnosis of a sleep disordered breathing syndrome 8. Use of CPAP or BIPAP non-invasive ventilation as home regime 9. 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) 10. Receiving non-invasive ventilation 11. Unable or unwilling to participate 12. Member of a vulnerable population such as pregnant women or prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoventilation | Change from baseline measurement observed within 60 minutes after opioid administration | The number of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemia | Change from baseline measurement observed within 60 minutes after opioid administration ] | The number of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sedation | Change from baseline assessment observed within 60 minutes after opioid administration ] | The number of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where S represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study |
Countries
United States
Outcome results
None listed