Incidence of Opioid-Induced Respiratory Depression in Medical and Trauma Patients
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ClinicalTrials.gov Identifier: NCT03647696
Recruitment Status : Unknown
Verified August 2018 by Poudre Valley Health System. Recruitment status was: Not yet recruiting
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.
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
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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 :
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:
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 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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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 89 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Spontaneously breathing adults 18-89 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
Less than 18 or greater than 89 years of age
Transfer to the general care floor from the ICU
Receiving intrathecal or epidural opioids
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
Receiving non-invasive ventilation
Presence of a co-morbidity that impacts respiration or ventilation (e.g COPD or pulmonary fibrosis)
Unwilling or unable to participate
Member of a vulnerable population such as pregnant women or prisoners.