Incidence OIRD Medical and Trauma Patients

Status unconfirmed

Conditions studied: Respiratory Depression, Sedation

In brief

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.

Key facts

Study ID

NCT03948880

Run by

Community Health System

People needed

101

Starts

2019-07-29

Expected to finish

2019-11-29

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Spontaneously breathing adults 18 to 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
• Able to provide written informed consent

You may not qualify if…

• Age is less than 18 years or greater than 89 years
• Transfer to the general care floor from the ICU
• Provider order for respiratory monitoring using continuous capnography
• Receiving intrathecal or epidural opioids
• Trauma patient with a nerve block
• 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
• 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)
• Receiving non-invasive ventilation
• Unable or unwilling to participate
• Member of a vulnerable population such as pregnant women or prisoners

Where it is running

• Community Regional Medical Center — Fresno, California, United States

Full record on ClinicalTrials.gov

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