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临床试验/NCT02930863
NCT02930863已完成不适用

Prevention of Post Operative Hypoxia in the Post Anesthesia Care Unit Using Pulse Oximetry With Automated Verbal Prompts

University of Florida2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
2
主要终点
Change in the frequency of a participant's SpO2 level falling below 87%

研究概览

简要总结

This study will evaluate the effectiveness of an automated voice prompting system on post operative hypoxia within the Postoperative Anesthesia Care Unit (PACU). This will be done to detect an improvement of the patient experience and provider care through a decrease in the number of peripheral capillary oxygen saturation (SpO2) monitor alarms via the patients own ability to follow the instruction and improve their SpO2 levels.

详细描述

The investigators will examine and observe the patient's stay in the PACU and utilize the pulse oximetry software and data to analyze the ability to evaluate the difference in patient oxygenation levels and supplemental oxygen use with automated verbal prompted monitoring versus a standard care control group. As well as determine if automated verbal prompted monitoring leads to less monitor alarms and subsequent improvement of subjective alarm fatigue and patient satisfaction with their care versus standard care.

The pulse oximeter will have a finger probe that will be attached to the patient's middle finger to read the patient's SpO2 levels. Each time the participant's pulse oximetry value declines to 93% or less, an automated verbal prompt, created via the software, will generate as a soft prompt. This will be followed up by a hard prompt if no improvement is seen in their oxygenation level after a period of time. A positive feedback elicitation will be given if the participant's saturation levels increase above 93%. This automated verbal prompt guidance will take place during the entirety of the investigational group's PACU stay.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • planned general anesthetic
  • ability to provide informed consent

排除标准

  • use of regional anesthesia
  • altered mental status
  • hearing impairment requiring assistive devices
  • inability to hear normal conversational voice during the consent process
  • inability preoperatively to squeeze probe finger against thumb for any reason
  • baseline SpO2 less than or equal to 93% (on room air or baseline home oxygen requirement)
  • history of methemoglobinemia
  • suspected or confirmed carbon monoxide (CO) poisoning
  • planned admission to an intensive care unit

研究组 & 干预措施

Control Non-Automated Group

Active Comparator

Participants assigned to this group will receive the standard of care procedures for the monitoring and treatment of hypoxemia. Complete brief post-PACU stay survey.

干预措施: Brief post-PACU stay survey. (Behavioral)

Automated Prompt Group

Experimental

Participants assigned to this group will utilize the automated verbal prompts to enable their ability to improve their current condition by following generated commands. Complete a questionnaire focused around their experience with the pulse oximetry software and its effects on the patient's satisfaction and experience.

干预措施: pulse oximetry software (Other)

Automated Prompt Group

Experimental

Participants assigned to this group will utilize the automated verbal prompts to enable their ability to improve their current condition by following generated commands. Complete a questionnaire focused around their experience with the pulse oximetry software and its effects on the patient's satisfaction and experience.

干预措施: Brief post-PACU stay survey. (Behavioral)

结局指标

主要结局

Change in the frequency of a participant's SpO2 level falling below 87%

时间窗: Change from baseline up to 24 hours

SpO2 will be monitored using the standard pulse oximeter system

次要结局

  • Change between the study groups number of pulse oximetry alarms(Change from baseline up to 24 hours)
  • Change between the study groups level of postoperative care satisfaction(Change from baseline up to 24 hours)
  • Change between the study groups level of alarm fatigue(Change from baseline up to 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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