Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

Comparison of a Procedural Oxygen Mask and High-Flow Nasal Cannula for the Prevention of Hypoxemia During Pediatric Upper Gastrointestinal Endoscopy Under Sedation: A Single-Center Randomized Controlled Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Upper gastrointestinal endoscopy is a commonly performed diagnostic and therapeutic procedure in children, allowing evaluation of the esophagus, stomach, and duodenum, as well as interventions such as biopsy, foreign body removal, and polypectomy. Sedation is routinely used, often at greater depths than for standard examinations. Due to anatomical and physiological differences, including smaller airway diameter, higher oxygen consumption, and lower functional residual capacity, pediatric patients are at higher risk of airway obstruction, hypoxemia, and hypoventilation compared to adults. The passage of the endoscope through the mouth further limits airway access and increases the risk of desaturation. Oxygenation during pediatric endoscopy is typically supported using nasal cannulas, high-flow systems, or procedural oxygen masks (POM™). This pilot randomized study aims to compare POM™ and high-flow nasal cannula in preventing hypoxemia during sedated pediatric upper gastrointestinal endoscopy, contributing evidence for safer sedation and airway management practices in children.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 16
Healthy Volunteers: f
View:

• Patients who consented to participate in the study

• Aged between 6 and 16 years

• Body weight \>30 kg

• ASA physical status I-II

• Children scheduled to undergo procedural sedation for non-emergency upper gastrointestinal endoscopy

Locations
Other Locations
Turkey
Kocaeli City Hospital
RECRUITING
Kocaeli
Contact Information
Primary
Bedirhan Günel, MD
bedirhangunel71@gmail.com
5069647656
Backup
Mehmet Yilmaz, Ass. Prof.
drmyilmaz33@gmail.com
505 217 44 32
Time Frame
Start Date: 2026-03-04
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 30
Treatments
Experimental: Group P
Oxygen delivered via Procedural Oxygen Mask (POM™) at a fixed flow of 15 L/min (approx. FiO₂ 95%) throughout the procedure.
Active_comparator: Group H
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.
Related Therapeutic Areas
Sponsors
Leads: Bedirhan Günel

This content was sourced from clinicaltrials.gov