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临床试验/NCT05595798
NCT05595798招募中不适用

Associations Between Breath Sound Frequency Pattern, Capnography and Electroencephalographic Density Spectrum Array During Deep Sedation in High Risk Patients.

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Occurence of airway obstruction during sedation

研究概览

简要总结

To investigate the associations bewteen the sedation level and the airway adverse effects by using the EEG, Airmod breath sound monitor and the capnography.

详细描述

Deep sedation is mandatory for many invasive procedures such as the digestive endoscopy, bronchoscopy and cystoscopy. However, deep sedation may induce respiratory adverse effects including airway obstruction, hypoventilation and apnea. These respiratory adverse effects, which may occur in more than 20% of high-risk groups (eg, children, the elderly, and patients with sleep apnea), hence, are the major concerns of the anesthetic care. However, It is difficult for clinicians to objectively quantify the sedation level and find the associations of inadequate sedation level and the occurrence of respiratory adverse effects.

Airway obstruction and respiratory rate decline during deep sedation are conventionally monitored by using capnography(EtCO2 waveform). However, previous studies have tracheal breath sound monitoring can achieve better detection accuracy than the capnography. The novel Airmod smart breathing monitor has the functions of breath sound recording, anti-noise signal processing, event recording and respiratory rate analysis and research. Through the continuous breath sound recording, airway adverse effects during sedation may be detected, and these breathing spectrogram can be presented for image analysis. This is helpful for researcher to identify associations between airway adverse effect and the sedation level.

The state-of-art anesthetic depth is determined by using the electroencephalogram (EEG). Both EEG raw data or the EEG spectrogram graphs may be used for quantify the sedation level with respiratory adverse effects. Accordingly, this study aims to investigate the associations between the sedation level and the airway adverse effects by using the EEG monitor, Airmod breath sound monitor and the capnography.

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
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing procedural sedation with expected produre time longer than 30 minutes
  • •Pediatric group: age 4-8 year-old
  • •Geriatric group: age>= 65 year-old

排除标准

  • •Preoperative active brain conditions (dementia, Parkinsonism, seizure)
  • •A history of nasal or oral tumor

结局指标

主要结局

Occurence of airway obstruction during sedation

时间窗: 0.5-2 hours

Airway obstruction detected by the breath sound monitor or capnography

Occurence of apnea event during sedation

时间窗: 0.5-2 hours

Apnea detected by the breath sound monitor or capnography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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