跳至主要内容
临床试验/NCT00457080
NCT00457080已完成不适用

Application of Capnography Monitoring on the General Care Nursing Unit

Texas Health Resources2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年10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
60
试验地点
2
主要终点
Increase the detection of undiagnosed obstructive sleep apnea (OSA)

研究概览

简要总结

The aim of this study is to increase the detection of undiagnosed obstructive sleep apnea (OSA) and secondly to increase the sensitivity for detection of respiratory depression (< 6 breaths per minute) in post operative patients on the general care nursing unit.

详细描述

Measures: This is an IRB approved prospective trial beginning with randomization in the post anesthesia care unit (PACU) and continuing for thirty six hours post orthopedic surgical procedure. The patients are randomized into a capnography or standard of care group and the percentage of newly identified OSA patients were measured in each group using the criteria set forth by 2006 American Society of Anesthesiologist practice guideline (Anesthesiology 2006; 104:1081-93).

Background/Changes: Hospital complications are three times higher in patients with obstructive sleep apnea and the majority of these complications are related to opioid induced respiratory depression (Mayo Clin Proc Sept 2001:897-905). American Society of Anesthesiologist 2006 practice guideline for perioperative management of patients with obstructive sleep apnea (Anesthesiology 2006; 104:1081-93) lists the criteria for identifying undiagnosed obstructive sleep apnea. One of the risk factors in the guideline lists apnea (pauses in breathing). Capnography measures apnea episodes and continuously monitors respiration rate.

As previously described, five percent of the general population has obstructive sleep apnea (OSA) and the prevalence among patients requiring surgery is 9% (NEJM 1993; 328:1230-1235). Between 50-80% of OSA individuals are undiagnosed when presenting for surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Orthopedic surgical procedure
  • Respiration rate < 10 breaths per minute requiring supplement oxygen
  • One of the following:
  • body mass index >30
  • history of snoring
  • basal rate of opioid, and
  • one event of RR <10 in the post anesthesia care unit.

排除标准

  • < 18 y/o
  • A diagnosis of obstructive sleep apnea.

结局指标

主要结局

Increase the detection of undiagnosed obstructive sleep apnea (OSA)

次要结局

  • Increase the sensitivity for detection of respiratory depression (< 6 breaths per minute) in post operative patients on the general care nursing unit

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验