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临床试验/NCT03076047
NCT03076047Unknown不适用

Preliminary Characterization of the Capnography Profile of Obstructive Sleep Apnea (OSA) Patients in the Post-Anesthesia Care Unit (PACU)

University of South Florida1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
end-tidal carbon dioxide (ETCO2)

研究概览

简要总结

To understand if a progressive increase in end-tidal carbon dioxide (CO2) levels are heralding respiratory difficulties before desaturation measured from capnography in obstructive sleep apnea patients, with the use of nasal prongs, transcutaneous monitors, Capnostream, and Massimo technologies.

详细描述

Background and Significance Carbon dioxide (CO2) levels can be monitored throughout the respiratory cycle via capnography. In this way, capnography allows healthcare professionals to follow a number of respiratory factors (i.e., depression, apnea, and hypercapnia) in real-time. Earlier detection of alterations to ventilation status will better enable providers to more accurately dose medications during procedures, especially in at-risk patient populations such as patients with obstructive sleep apnea (OSA) [1, 2].

In a recent study of bariatric patients, approximately 15% experience postoperative pulmonary complications. These patients could benefit significantly from capnography monitoring as this measure can very accurately estimate the prevalence of respiratory complications.

Through this study we seek to understand how end-tidal CO2 (ETCO2) levels of patients with obstructive sleep apnea vary when patients are in the post-anesthesia care unit (PACU). By collecting information on patient outcomes, we hope to better understand the value of this monitoring technique in an at-risk patient population. Though capnography in the PACU has not previously been demonstrated to improve patient safety or satisfaction, capnography has never been studied in a population of patients who are at risk of obstructive sleep apnea.

Study Design This is a prospective, blinded observational pilot study to monitor if changes in end-tidal CO2 levels provide incremental value over pulse oximetry when detecting respiratory difficulties (i.e., hypercapnia).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years of age
  • Patients who have are at TGH for bariatric surgery
  • BMI > 30
  • At risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire

排除标准

  • <18 years of age
  • Not at risk of obstructive sleep apnea according to TGH STOP-BANG questionnaire

结局指标

主要结局

end-tidal carbon dioxide (ETCO2)

时间窗: 2-3 hours

end-tidal carbon dioxide (ETCO2) values averaged over 5 minute intervals

次要结局

  • oxygen saturation (SPO2)(2-3 hours)

研究者

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

Enrico Camporesi

Principal Investigator

University of South Florida

研究点 (1)

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