Procedural Oxygen Mask vs Nasal Cannula in Pediatric Endoscopy

NCT ID: NCT07234175

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2026-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group P

Participants will receive oxygen via a Procedural Oxygen Mask (POM) at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation.

Group Type: EXPERIMENTAL

Procedural Oxygen Mask

Intervention Type: DEVICE

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

Group N

Participants will receive oxygen via a conventional nasal cannula at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation.

Group Type: ACTIVE_COMPARATOR

Nasal Cannula

Intervention Type: DEVICE

Provides standard oxygen delivery through the nostrils during sedation.

Interventions

Procedural Oxygen Mask

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

Intervention Type: DEVICE

Nasal Cannula

Provides standard oxygen delivery through the nostrils during sedation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Lack of parental consent or refusal to sign the participant consent form
• History of endotracheal intubation within the past 3 months
• History of lower respiratory tract infection within the past 3 months
• History of intensive care unit (ICU) admission within the past 3 months
• Presence of a tracheostomy
• History of tracheostomy placement
• Patients with oxygen dependency due to any underlying disease
• Known pulmonary or cardiac disease
• Known congenital craniofacial anomalies
• Congenital or acquired upper airway malformations

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bedirhan Günel

OTHER_GOV

Sponsor Role: lead

Responsible Party

Bedirhan Günel

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bedirhan Günel, MD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli City Hospital

Locations

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Bedirhan Günel, MD

Role: CONTACT

bedirhangunel71@gmail.com

05069647656

Facility Contacts

MEHMET YILMAZ, Assoc. Prof.

Role: primary

drmyilmaz33@gmail.com

505 217 44 32 ext. +90

Other Identifiers

KSH-ANREA-BG-08

Identifier Type: -

Identifier Source: org_study_id