Clincosm LogoSign in Get a demo

Incidence OIRD Medical and Trauma Patients

Sponsor
Fresno Community Hospital and Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03948880
Collaborator
University of California, Los Angeles (Other), Medtronic (Industry)
101
Enrollment
1
Location
4
Anticipated Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    101 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jul 29, 2019
    Anticipated Primary Completion Date :
    Oct 29, 2019
    Anticipated Study Completion Date :
    Nov 29, 2019

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Hypoventilation [Change from baseline measurement observed within 60 minutes after opioid administration]

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

    3. Hypoventilation [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 Outcome Measures

    1. 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.

    2. Hypoxemia [Change from baseline measurement observed within 60 minutes after opioid administration ]]

      The percentage of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.

    3. Hypoxemia [Change from baseline measurement observed within 60 minutes after opioid administration ]]

      The characteristics of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.

    Other Outcome Measures

    1. 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

    2. Sedation [Change from baseline assessment observed within 60 minutes after opioid administration ]]

      The percentage 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

    3. Sedation [Change from baseline assessment observed within 60 minutes after opioid administration ]]

      The characteristics 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

    4. Sedation [Change from baseline assessment observed within 60 minutes after opioid administration]

      The number of subjects who experience unintended sedation 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

    5. Sedation [Change from baseline assessment observed within 60 minutes after opioid administration]

      The percentage of subjects who experience unintended sedation 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

    6. Sedation [Change from baseline assessment observed within 60 minutes after opioid administration]

      The characteristics of subjects who experience unintended sedation 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

    7. Sedation [Change from baseline assessment observed within 60 minutes after opioid administration]

      The number of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study

    8. Sedation [Change from baseline assessment observed within 60 minutes after opioid administration]

      The percentage of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study

    9. Sedation [Change from baseline assessment observed within 60 minutes after opioid administration]

      The characteristics of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Community Regional Medical Center Fresno California United States 93621

    Sponsors and Collaborators

    • Fresno Community Hospital and Medical Center
    • University of California, Los Angeles
    • Medtronic

    Investigators

    • Principal Investigator: Susan J Dempsey, PhD(c), UCLA and Community Regional Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Susan Dempsey Ortega, Clinical Nurse Specialist, Fresno Community Hospital and Medical Center
    ClinicalTrials.gov Identifier:
    NCT03948880
    Other Study ID Numbers:
    • FresnoCHMC
    First Posted:
    May 14, 2019
    Last Update Posted:
    Jul 31, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Jul 31, 2019