Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Kenneth Ng, DO
- Numero di telefono: 410-955-8769
- Email: kng13@jhmi.edu
Backup dei contatti dello studio
- Nome: Ningfei Li, MD
- Numero di telefono: 4109556070
- Email: nli56@jh.edu
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Reclutamento
- Charlotte R. Bloomberg Children's Center
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Altro: Left lateral position first, supine position second
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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.
|
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Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Diameter
Lasso di tempo: During procedure only (less than 10 minutes)
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Diameter of esophagus (mm)
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During procedure only (less than 10 minutes)
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Cross sectional area
Lasso di tempo: During procedure only (less than 10 minutes)
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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
Lasso di tempo: During procedure only (less than 10 minutes)
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esophageal compliance (mm3/mmHg)
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During procedure only (less than 10 minutes)
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distensibility index
Lasso di tempo: During procedure only (less than 10 minutes)
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esophageal distensibility index(mm2/mmHg)
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During procedure only (less than 10 minutes)
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Pressure
Lasso di tempo: During procedure only (less than 10 minutes)
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intraluminal esophageal pressure (mmHg)
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During procedure only (less than 10 minutes)
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Differences in diameter
Lasso di tempo: During procedure only (less than 10 minutes)
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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
Lasso di tempo: During procedure only (less than 10 minutes)
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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
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During procedure only (less than 10 minutes)
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Differences in esophageal compliance (mm3/mmHg)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
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During procedure only (less than 10 minutes)
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Kenneth Ng, DO, Johns Hopkins University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie genetiche, congenite
- Malattie del sistema immunitario
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Ipersensibilità, immediata
- Ipersensibilità
- Eosinofilia
- Disturbi dei leucociti
- Malattie ematologiche
- Malattie esofagee
- Malattie della pelle
- Gastroenterite
- Anomalie congenite
- Malattie otorinolaringoiatriche
- Malattie della pelle, genetiche
- Malattie faringee
- Anomalie della pelle
- Malattie della pelle, vescicolobollose
- Esofagite
- Malattie e anomalie congenite, ereditarie e neonatali
- Comportamento
- Malattie della pelle e del tessuto connettivo
- Malattie emiche e linfatiche
- Comportamento sociale
- Disturbi della deglutizione
- Epidermolisi Bollosa
- Esofagite eosinofila
- Stenosi esofagea
- Acalasia esofagea
- Disturbi della motilità esofagea
- Inganno
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- IRB00560539
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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