Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-21
SponsorJohns Hopkins University

About this trial

This is a prospective, single-center, crossover study comparing EndoFLIP measurements obtained in two patient positions, supine and left lateral decubitus, in pediatric and young adult patients. The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 and older that utilizes high-resolution impedance planimetry and volume-controlled distension to assess esophagogastric junction function. Currently, no standardized positioning protocol exists, and proceduralists perform EndoFLIP based on individual preference, either supine or left lateral decubitus. This variability may introduce measurement inconsistencies, particularly when comparing preoperative and postoperative assessments performed in different positions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • EndoFlip

    Diagnostic test

    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.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Left lateral position first, supine position secondOther 1 intervention
Group B: supine position first, Left lateral position secondOther 1 intervention

Trial outcomes

Primary outcomes

1

Diameter

Diameter of esophagus (mm)

Time frame
During procedure only (less than 10 minutes)
2

Cross sectional area

Esophageal cross sectional area measured in square millimeters (mm²)

Time frame
During procedure only (less than 10 minutes)
3

Compliance

esophageal compliance (mm3/mmHg)

Time frame
During procedure only (less than 10 minutes)
4

distensibility index

esophageal distensibility index(mm2/mmHg)

Time frame
During procedure only (less than 10 minutes)

Secondary outcomes

1

Differences in diameter

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

Time frame
During procedure only (less than 10 minutes)
2

Differences in Cross sectional area

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

Time frame
During procedure only (less than 10 minutes)
3

Differences in esophageal compliance (mm3/mmHg)

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

Time frame
During procedure only (less than 10 minutes)
4

Differences in esophageal distensibility index(mm2/mmHg)

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

Time frame
During procedure only (less than 10 minutes)

Other outcomes

Sponsors and contacts

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