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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

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
Respiratory Depression Sedation

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Study Type : Observational
Estimated 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 : July 29, 2019
Estimated Primary Completion Date : October 29, 2019
Estimated Study Completion Date : November 29, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948880


Locations
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United States, California
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
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Principal Investigator: Susan J Dempsey, PhD(c) UCLA and Community Regional Medical Center
Publications:
Dempsey, SF, Khanna, AK, Buhre, W, Saager, L, DiStefano, P, Weingarten, T., Dahan, A., Brazzi, L., Overdyk, F., McIntyre, R. Incidence of Respiratory Depression and Derivation of a Novel Opioid-Induced Respriatory Depression Risk Prediction Tool. Poster presentation. UCLA School of Nursing Research Day, May 14, 2019.
Khanna, A, Buhre, W, Saager, L, DiStefano, P, Weingarten, R, Dahan, A, Brazzi, L, & Overdyk, R. Derivation and validation of a novel opioid-induced respiratory depression risk predication tool. Critical Care Medicine 47(1):36, 2019.

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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    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases