Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention
研究概览
地位
详细说明
After obtaining study consent, each patient underwent measurements of upper airway cross-sectional area (CSA) during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position. This method has been previously used and validated in pregnant women.
In the patients who further gave consent for the sleep study, polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Postpartum mothers within 48 hours of delivery in a major academic teaching hospital.
- Age over 18 years.
- Admitted to the Massachusetts General Hospital OB service for the delivery.
- Interventions will be randomly assigned to the patients enrolled in this study
Exclusion Criteria:
- Age under 18 years.
- History of pre-existing pulmonary and cardiac diseases, including bronchial asthma, cystic fibrosis, chronic obstructive lung disease, neck and chest tumors (thyroid, mediastinal, etc.), irradiation to the neck and/or chest, and congenital airway deformities, other critically-ill conditions.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Elevated body position
We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.
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45 degrees elevated upper body position
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有源比较器:supine body position
We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.
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non-elevated upper body position
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep
大体时间:48 hours after delivery
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We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.
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48 hours after delivery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients
大体时间:48 hours after delivery
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Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery.
The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.
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48 hours after delivery
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合作者和调查者
调查人员
- 首席研究员:Matthias Eikermann, MD, Ph.D、Massachusetts General Hospital Department of Anesthesia, Critical Care and Pain Medicine
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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