Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
研究概览
详细说明
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 years and older and it utilizes high-resolution impedance planimetry and volume-controlled distension to evaluate the GI lumen including the esophagogastric junction. EndoFLIP has become an invaluable tool in pediatric gastroenterology helping to characterize various luminal conditions including but not limited to esophageal stenosis and compression, screening for dysmotility, guiding esophageal dilation through the selection of the optimal dilator size, among others. Despite its increasing clinical utility, there is currently no standardized protocol for its use and much of the technique is derived from adult practice.
Proceduralists perform measurements based on individual preference, with some favoring the supine position and others preferring the left lateral decubitus position. This lack of consensus has been an active topic of discussion among pediatric advanced endoscopists who perform EndoFLIP, yet no published studies exist comparing measurements obtained in different positions. This variability presents a significant clinical problem because positioning may influence EndoFLIP parameters through several physiological mechanisms. In the supine position, abdominal viscera shift posteriorly, potentially altering esophagogastric junction geometry and increasing intra-abdominal pressure. In the left lateral decubitus position, the gastric fundus falls away from the esophagogastric junction due to gravity, possibly reducing external compression and changing the angle of His. Additionally, diaphragmatic crural tension, thoracic mechanics, and vascular engorgement patterns may differ between positions, all of which could affect luminal measurements. These positional differences have important clinical implications, particularly when comparing preoperative and postoperative measurements, assessing dilation durability within the same procedure, or monitoring disease progression longitudinally over multiple visits. If measurements are obtained in different positions across these clinical scenarios, apparent changes in esophagogastric junction function may be artifactual rather than reflective of true physiological change.
The investigators hypothesize that patient positioning, supine versus left lateral decubitus, impacts EndoFLIP measurements. This is a non-directional hypothesis, as there is currently insufficient evidence to predict whether measurements will be higher or lower in one position compared to the other.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Kenneth Ng, DO
- 电话号码:410-955-8769
- 邮箱:kng13@jhmi.edu
研究联系人备份
- 姓名:Ningfei Li, MD
- 电话号码:4109556070
- 邮箱:nli56@jh.edu
学习地点
-
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Maryland
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Baltimore、Maryland、美国、21287
- 招聘中
- Charlotte R. Bloomberg Children's Center
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- must be between 5 years and 21 years of age at the time of the procedure, which is within the FDA-approved age range for EndoFLIP use.
- participants must be scheduled to undergo a clinically indicated EndoFLIP procedure at Johns Hopkins Children's Center.
- participants must have a parent or legal guardian who is able to provide written informed consent in English, or with the assistance of translation services for non-English speakers.
- participants who are of appropriate age and developmental capacity must be able to provide assent for study participation.
- participants must be candidates for general anesthesia as determined by the anesthesia team.
Exclusion Criteria:
- patients younger than 5 years of age or 22 years of age and older will be excluded.
- patients who have contraindications to EndoFLIP will be excluded, including situations where upper endoscopy is generally contraindicated such as known or suspected gastrointestinal perforation, hemodynamic instability, severe coagulopathy, or inability to safely undergo general anesthesia.
- patients who cannot be safely positioned in both supine and left lateral decubitus positions due to medical or anatomical considerations will be excluded.
- pregnant patients will be excluded. Pregnancy status will be determined by patient or guardian report and, when clinically indicated, by urine or serum pregnancy testing per institutional protocols for patients of childbearing potential.
- patients whose parent or legal guardian declines to provide informed consent or patients who decline to provide assent when age-appropriate will be excluded.
- patients for whom the proceduralist or anesthesia team determines that participation in the research protocol would pose additional risk beyond routine clinical care will be excluded.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Left lateral position first, supine position second
|
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 years and older and it utilizes high-resolution impedance planimetry and volume-controlled distension to evaluate the GI lumen.
|
|
其他:supine position first, Left lateral position second
|
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 years and older and it utilizes high-resolution impedance planimetry and volume-controlled distension to evaluate the GI lumen.
|
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 |
|---|---|---|
|
Diameter
大体时间:During procedure only (less than 10 minutes)
|
Diameter of esophagus (mm)
|
During procedure only (less than 10 minutes)
|
|
Cross sectional area
大体时间:During procedure only (less than 10 minutes)
|
Esophageal cross sectional area measured in square millimeters (mm²)
|
During procedure only (less than 10 minutes)
|
|
Compliance
大体时间:During procedure only (less than 10 minutes)
|
esophageal compliance (mm3/mmHg)
|
During procedure only (less than 10 minutes)
|
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distensibility index
大体时间:During procedure only (less than 10 minutes)
|
esophageal distensibility index(mm2/mmHg)
|
During procedure only (less than 10 minutes)
|
|
Pressure
大体时间:During procedure only (less than 10 minutes)
|
intraluminal esophageal pressure (mmHg)
|
During procedure only (less than 10 minutes)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Differences in diameter
大体时间:During procedure only (less than 10 minutes)
|
calculated difference in diameter between supine vs left lateral position (mm), percentage difference from left lateral position to supine position and also supine to left lateral position
|
During procedure only (less than 10 minutes)
|
|
Differences in Cross sectional area
大体时间:During procedure only (less than 10 minutes)
|
calculated difference in Cross sectional area between supine vs left lateral position (mm2), percentage difference from left lateral position to supine position and also supine to left lateral position
|
During procedure only (less than 10 minutes)
|
|
Differences in esophageal compliance (mm3/mmHg)
大体时间:During procedure only (less than 10 minutes)
|
calculated difference in esophageal compliance (mm3/mmHg) between supine vs left lateral position, percentage difference from left lateral position to supine position and also supine to left lateral position
|
During procedure only (less than 10 minutes)
|
|
Differences in esophageal distensibility index(mm2/mmHg)
大体时间:During procedure only (less than 10 minutes)
|
calculated difference in esophageal distensibility index(mm2/mmHg) between supine vs left lateral position, percentage difference from left lateral position to supine position and also supine to left lateral position
|
During procedure only (less than 10 minutes)
|
|
Differences in intraluminal esophageal pressure (mmHg)
大体时间:During procedure only (less than 10 minutes)
|
calculated difference in intraluminal esophageal pressure (mmHg) between supine vs left lateral position, percentage difference from left lateral position to supine position and also supine to left lateral position
|
During procedure only (less than 10 minutes)
|
合作者和调查者
调查人员
- 首席研究员:Kenneth Ng, DO、Johns Hopkins University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00560539
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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