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Clinical Trials/NCT03948880
NCT03948880
Unknown
Not Applicable

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

Fresno Community Hospital and Medical Center1 site in 1 country101 target enrollmentJuly 29, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Depression
Sponsor
Fresno Community Hospital and Medical Center
Enrollment
101
Locations
1
Primary Endpoint
Hypoventilation
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 29, 2019
End Date
November 29, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Dempsey Ortega

Clinical Nurse Specialist

Fresno Community Hospital and Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hypoventilation

Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration

The characteristics of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.

Secondary Outcomes

  • Hypoxemia(Change from baseline measurement observed within 60 minutes after opioid administration ])

Study Sites (1)

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