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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03647696

Enrollment

Registered

2018-08-27

Start date

2018-08-30

Completion date

2018-08-30

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Depression, Sedation

Keywords

respiratory depression, opioid-induced sedation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Sedation	Change from baseline assessment observed within 60 minutes after opioid administration	Sedation assessment will be preformed using the Moline-Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of Sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study

Outcome results