Incidence of Opioid-induced Respiratory Depression in Medical and Trauma Patients on the General Care Floor Receiving Patient-controlled Analgesia and Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Hypoventilation
研究概览
简要总结
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 (IV) 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneously breathing adults 18 to 89 years of age
- •English speaking
- •Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
- •Admitted to the general care floor from the emergency department
排除标准
- •Less than 18 or greater than 89 years of age
- •Transfer to the general care floor from the Intensive Care Unit
- •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 Continuous Positive Airway Pressure or (CPAP) or Bilevel Positive Airway Pressure (BIPAP) non-invasive ventilation as home regime
- •Receiving non-invasive ventilation
- •Presence of a co-morbidity that impacts respiration or ventilation (e.g Chronic Obstructive Pulmonary Disease or Pulmonary Fibrosis)
- •Unwilling or unable to participate
- •Member of a vulnerable population such as pregnant women or prisoners.
结局指标
主要结局
Hypoventilation
时间窗: 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)
次要结局
- Hypoxemia(Change from baseline measurement observed within 60 minutes after opioid administration)