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

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ClinicalTrials.gov Identifier: NCT03647696
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
University of Colorado Health
University of California, Los Angeles
Medtronic
Information provided by (Responsible Party):
Poudre Valley Health System

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 : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Opioid-induced Respiratory Depression in Medical and Trauma Patients on the General Care Floor Receiving PCA and Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study
Estimated Study Start Date : August 27, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

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 aministration ]
    Continuous respiratory monitoring using capnography will be performed for collecting data of end-tidal carbon dioxide (etCO2)


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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

  2. Sedation [ Time Frame: Change from baseline assessment observed with 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



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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 IV opioids for acute pain.
Criteria

Inclusion Criteria:

  1. Spontaneously breathing adults 18-89 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 ICU
  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 CPAP or 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 COPD or pulmonary fibrosis)
  9. Unwilling or unable to participate
  10. 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): NCT03647696


Contacts
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Contact: Laurie Blumberg-Romero, MA, CRA 303-724-9138 blumberg-romero.laurie@uchealth.org
Contact: Elizabeth Graf, MS, CCRP 719-365-6173 graf.elizabeth@uchealth.org

Sponsors and Collaborators
Poudre Valley Health System
University of Colorado Health
University of California, Los Angeles
Medtronic
Investigators
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Principal Investigator: Susan J Dempsey, PhD(c) UCLA and UCHealth

Publications:

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Responsible Party: Poudre Valley Health System
ClinicalTrials.gov Identifier: NCT03647696     History of Changes
Other Study ID Numbers: PoudreVHS
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not decided whether the data will be available for sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poudre Valley Health System:
respiratory depression, opioid-induced sedation

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Respiratory Insufficiency
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents