Using Capnography to Reduce Hypoxia During Pediatric Sedation
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Yale University
临床试验: NCT01463527
BioSeek: nct01463527
关键词
抽象
The investigators hypothesize that the addition of capnography during moderate sedation will improve recognition of hypoventilation and apnea. This will lead to an increased frequency of staff interventions such as verbal or physical stimulation for these events in order to improve ventilation which will in turn lead to a reduction in the frequency of oxygen desaturations. If capnography proves to be effective in creating earlier detection and intervention for hypoventilation and apnea during moderate sedation provided by non-anesthesiologists, this device can be used in a variety of clinical settings to enhance patient safety.
日期
| 最后验证: | 11/30/2017 |
| 首次提交: | 10/23/2011 |
| 提交的预估入学人数: | 10/31/2011 |
| 首次发布: | 11/01/2011 |
| 上次提交的更新: | 12/12/2017 |
| 最近更新发布: | 01/10/2018 |
| 首次提交结果的日期: | 01/13/2014 |
| 首次提交质量检查结果的日期: | 07/07/2014 |
| 首次发布结果的日期: | 08/03/2014 |
| 实际学习开始日期: | 08/31/2011 |
| 预计主要完成日期: | 11/30/2012 |
| 预计完成日期: | 11/30/2012 |
状况或疾病
Hypoventilation
Hypoxia
干预/治疗
Device: Nellcor NPB-70 Capnograph
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Open Capnography | |
| Placebo Comparator: Capnography Blind |
资格标准
| 有资格学习的年龄 | 1 Year 至 1 Year |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Children 1-20 years old who require IV sedation in the Pediatric Emergency Department at Yale-New Haven Children's Hospital Exclusion Criteria: - Unable to tolerate nasal-oral cannula - Conditions that effect end-tidal carbon dioxide measurement (active asthma, diabetic ketoacidosis, severe dehydration or trauma) - Intubation |
结果
主要结果指标
1. Frequency of Staff Interventions for Hypoventilation. [Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)]
These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.
次要成果指标
1. Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%. [Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)]
While there were 77 patients per group, each patient had vital signs measured every 30 seconds for the duration of their stay. This resulted in a variable amount of time points (data points) recorded per patient. Our event frequency was the number of events (outcome measure of abnormal vital signs) per number of time points for each patient. This is presented as an event rate.
