Clinical trial NCT03948880: Incidence OIRD Medical and Trauma Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Depression
Sedation
Lead sponsor: Fresno Community Hospital and Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Medtronic
First posted: 2019-05-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target study population will be hospitalized, adult medical or trauma patients on the general care floor receiving patient-controlled analgesia or nurse administered intravenous opioids for acute pain.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hypoventilation
timeFrame: Change from baseline measurement observed within 60 minutes after opioid administration
measure: Hypoventilation
timeFrame: Change from baseline measurement observed within 60 minutes after opioid administration
measure: Hypoventilation
timeFrame: Change from baseline measurement observed within 60 minutes after opioid administration
Secondary outcomes:
measure: Hypoxemia
timeFrame: Change from baseline measurement observed within 60 minutes after opioid administration ]
measure: Hypoxemia
timeFrame: Change from baseline measurement observed within 60 minutes after opioid administration ]
measure: Hypoxemia
timeFrame: Change from baseline measurement observed within 60 minutes after opioid administration ]
Other outcomes:
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration ]
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration ]
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration ]
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration
measure: Sedation
timeFrame: Change from baseline assessment observed within 60 minutes after opioid administration
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
Study officials:
affiliation: UCLA and Community Regional Medical Center
name: Susan J Dempsey, PhD(c)
role: PRINCIPAL_INVESTIGATOR
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