Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Kenneth Ng, DO
- 電話番号:410-955-8769
- メール:kng13@jhmi.edu
研究連絡先のバックアップ
- 名前:Ningfei Li, MD
- 電話番号:4109556070
- メール:nli56@jh.edu
研究場所
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21287
- 募集
- Charlotte R. Bloomberg Children's Center
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の: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.
|
|
他の: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diameter
時間枠:During procedure only (less than 10 minutes)
|
Diameter of esophagus (mm)
|
During procedure only (less than 10 minutes)
|
|
Cross sectional area
時間枠:During procedure only (less than 10 minutes)
|
Esophageal cross sectional area measured in square millimeters (mm²)
|
During procedure only (less than 10 minutes)
|
|
Compliance
時間枠:During procedure only (less than 10 minutes)
|
esophageal compliance (mm3/mmHg)
|
During procedure only (less than 10 minutes)
|
|
distensibility index
時間枠:During procedure only (less than 10 minutes)
|
esophageal distensibility index(mm2/mmHg)
|
During procedure only (less than 10 minutes)
|
|
Pressure
時間枠:During procedure only (less than 10 minutes)
|
intraluminal esophageal pressure (mmHg)
|
During procedure only (less than 10 minutes)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Differences in diameter
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Kenneth Ng, DO、Johns Hopkins University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00560539
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。