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临床试验/NCT03948880
NCT03948880Unknown不适用

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

Fresno Community Hospital and Medical Center1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2019年7月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
101
试验地点
1
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 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

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Hypoventilation

时间窗: 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.

次要结局

  • Hypoxemia(Change from baseline measurement observed within 60 minutes after opioid administration ])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Dempsey Ortega

Clinical Nurse Specialist

Fresno Community Hospital and Medical Center

研究点 (1)

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