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Procedural Oxygen Mask vs Nasal Cannula in Pediatric Endoscopy

NCT07234175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-03-05

No results posted yet for this study

Summary

Upper gastrointestinal endoscopy is a commonly performed diagnostic and, when necessary, therapeutic procedure in pediatric patients for the evaluation of the esophagus, stomach, and duodenum. Additional interventions such as biopsy, foreign body removal, or polypectomy can also be performed during the same session. Sedation is generally required during the procedure, and the depth of sedation is often greater than that used for routine examinations.

Because of anatomical and physiological differences in children-such as smaller airway diameter, higher oxygen consumption, and lower functional residual capacity-the risks of upper airway obstruction, hypoxemia, and hypoventilation are higher than in adults. The passage of the endoscope through the mouth, combined with the respiratory depressant effects of sedatives and the smaller airway diameter, increases the likelihood of hypoxemia and limits the anesthesia team's access to the airway. Therefore, maintaining airway stability and optimizing oxygenation during sedation are particularly critical in pediatric patients.

Currently, several oxygen delivery methods are used during upper gastrointestinal endoscopy, including conventional nasal cannulas, high-flow nasal oxygen systems, and procedural oxygen masks. The Procedural Oxygen Mask (POM™) is a specially designed device that delivers oxygen through both the mouth and nose while allowing endoscope passage and continuous capnography monitoring. Previous studies in adults have shown that the use of POM™ or high-flow nasal oxygen reduces the incidence of hypoxemia during endoscopy. However, in children, there is a lack of randomized controlled trials directly comparing POM™ with nasal cannula use.

This single-center prospective randomized controlled trial aims to compare the effectiveness of the Procedural Oxygen Mask (POM™) and nasal cannula in preventing hypoxemia during pediatric upper gastrointestinal endoscopy under sedation. The findings are expected to contribute to safer sedation practices and improved airway management strategies in pediatric endoscopic procedures.

Conditions

  • Hypoxemia

Interventions

DEVICE

Nasal Cannula

Provides standard oxygen delivery through the nostrils during sedation.

DEVICE

Procedural Oxygen Mask

Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.

Sponsors & Collaborators

  • Bedirhan Günel

    lead OTHER_GOV

Principal Investigators

  • Bedirhan Günel, MD · Kocaeli City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2026-03-03
Completion
2026-03-03

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234175 on ClinicalTrials.gov