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Incidence OIRD Medical and Trauma Patients

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ClinicalTrials.gov Identifier: NCT03948880
Recruitment Status : Enrolling by invitation
First Posted : May 14, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
University of California, Los Angeles
Medtronic
Information provided by (Responsible Party):
Susan Dempsey Ortega, Fresno Community Hospital and Medical Center

Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 14, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date July 29, 2019
Estimated Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
  • Hypoventilation [ Time Frame: 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.
  • Hypoventilation [ Time Frame: 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.
  • 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.
Original Primary Outcome Measures
 (submitted: May 10, 2019)
Hypoventilation [ Time Frame: 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)
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2019)
  • Hypoxemia [ Time Frame: 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.
  • Hypoxemia [ Time Frame: 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.
  • Hypoxemia [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: May 10, 2019)
Hypoxemia [ Time Frame: 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)
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2019)
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: 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
Original Other Pre-specified Outcome Measures
 (submitted: May 10, 2019)
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ] ]
    Sedation assessment will be preformed using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represent normal sleep and increasing numbers represent increasing levels of Sedation and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: 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
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    Sedation assessment will be preformed 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
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Respiratory Depression
  • Sedation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 10, 2019)
101
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 29, 2019
Estimated Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03948880
Other Study ID Numbers FresnoCHMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Susan Dempsey Ortega, Fresno Community Hospital and Medical Center
Study Sponsor Fresno Community Hospital and Medical Center
Collaborators
  • University of California, Los Angeles
  • Medtronic
Investigators
Principal Investigator: Susan J Dempsey, PhD(c) UCLA and Community Regional Medical Center
PRS Account Fresno Community Hospital and Medical Center
Verification Date July 2019