Clinical trial NCT03647696: Incidence of Opioid-Induced Respiratory Depression in Medical and Trauma Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Respiratory Depression
Sedation
Keywords: respiratory depression, opioid-induced sedation
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
Collaborators: name: University of Colorado Health
name: University of California, Los Angeles
name: Medtronic
First posted: 2018-08-27
Enrollment: 0
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 PCA or nurse administered IV 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 (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.


Eligibility criteria: Inclusion Criteria:

1. Spontaneously breathing adults 18 to 89 years of age
2. English speaking
3. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
4. Admitted to the general care floor from the emergency department

Exclusion Criteria:

1. Less than 18 or greater than 89 years of age
2. Transfer to the general care floor from the Intensive Care Unit
3. Receiving intrathecal or epidural opioids
4. Inability or unwillingness to wear the etCO2 sampling line nasal cannula or pulse oximetry sensor
5. History or diagnosis of a sleep disordered breathing syndrome
6. Use of Continuous Positive Airway Pressure or (CPAP) or Bilevel Positive Airway Pressure (BIPAP) non-invasive ventilation as home regime
7. Receiving non-invasive ventilation
8. Presence of a co-morbidity that impacts respiration or ventilation (e.g Chronic Obstructive Pulmonary Disease or Pulmonary Fibrosis)
9. Unwilling or unable to participate
10. 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
Secondary outcomes:
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 with 60 minutes after opioid administration
Locations:
Study officials:
affiliation: UCLA and UCHealth
name: Susan J Dempsey, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References:
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