- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07780981
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Kenneth Ng, DO
- Telefonnummer: 410-955-8769
- E-Mail: kng13@jhmi.edu
Studieren Sie die Kontaktsicherung
- Name: Ningfei Li, MD
- Telefonnummer: 4109556070
- E-Mail: nli56@jh.edu
Studienorte
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21287
- Rekrutierung
- Charlotte R. Bloomberg Children's Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Diameter
Zeitfenster: During procedure only (less than 10 minutes)
|
Diameter of esophagus (mm)
|
During procedure only (less than 10 minutes)
|
|
Cross sectional area
Zeitfenster: During procedure only (less than 10 minutes)
|
Esophageal cross sectional area measured in square millimeters (mm²)
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During procedure only (less than 10 minutes)
|
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Compliance
Zeitfenster: During procedure only (less than 10 minutes)
|
esophageal compliance (mm3/mmHg)
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During procedure only (less than 10 minutes)
|
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distensibility index
Zeitfenster: During procedure only (less than 10 minutes)
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esophageal distensibility index(mm2/mmHg)
|
During procedure only (less than 10 minutes)
|
|
Pressure
Zeitfenster: During procedure only (less than 10 minutes)
|
intraluminal esophageal pressure (mmHg)
|
During procedure only (less than 10 minutes)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Differences in diameter
Zeitfenster: 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
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During procedure only (less than 10 minutes)
|
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Differences in Cross sectional area
Zeitfenster: 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)
|
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Differences in esophageal compliance (mm3/mmHg)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Kenneth Ng, DO, Johns Hopkins University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Genetische Krankheiten, angeboren
- Erkrankungen des Immunsystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Überempfindlichkeit, sofort
- Überempfindlichkeit
- Eosinophilie
- Leukozytenerkrankungen
- Hämatologische Erkrankungen
- Erkrankungen der Speiseröhre
- Hautkrankheiten
- Gastroenteritis
- Angeborene Anomalien
- Otorhinolaryngologische Erkrankungen
- Hautkrankheiten, genetisch
- Rachenkrankheiten
- Hautanomalien
- Hautkrankheiten, Vesikulobullöse
- Ösophagitis
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Verhalten
- Haut- und Bindegewebserkrankungen
- Hämische und lymphatische Krankheiten
- Soziales Verhalten
- Schluckstörungen
- Epidermolysis bullosa
- Eosinophile Ösophagitis
- Ösophagusstenose
- Ösophagus-Achalasie
- Motilitätsstörungen des Ösophagus
- Täuschung
Andere Studien-ID-Nummern
- IRB00560539
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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