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临床试验/NCT01082575
NCT01082575已完成不适用

Oxygen Saturation Monitoring in the General Care Floor (GCF): An Observational Study of Repetitive Reductions in Airflow

Medtronic - MITG3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
3
主要终点
Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.

研究概览

简要总结

The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern. This is an observational study of 100 post-operative patients who will be monitored with a pulse oximeter for a minimum of two nights and a maximum of five nights to determine the prevalence of this abnormal breathing pattern.

详细描述

No further details necessary or available.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 18 years or older
  • Discharge from the post-anesthesia care unit (PACU) to the GCF after any of the following major surgeries: bariatric surgery, major orthopedic surgery (e.g., total hip replacement), major general surgery (e.g., bowel resections, open cholecystectomy), and major gynecological surgery (e.g., radical hysterectomy)

排除标准

  • Pre-existing central neurological disease, including but not limited to recent traumatic brain injury, stroke, and neurodegenerative disease
  • Ongoing use of mechanical ventilation or continuous positive airway pressure in the GCF

结局指标

主要结局

Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.

时间窗: 5 days

Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing.

次要结局

  • Number of Participants With Adverse Events (AE) Caused by no Breathing(Five Nights)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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