POM vs HFNC for Hypoxemia Prevention in Children

NCT07234188 | Recruiting

• 1 other identifier: KSH-ANREA-BG-09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Lowest SpO₂ level during procedure

  The lowest peripheral oxygen saturation (SpO₂) recorded between the initiation of sedation and the removal of the gastroscope was defined as the primary outcome. It was measured via continuous pulse oximetry, and when SpO₂ fluctuated, the value maintained for more than 10 seconds was recorded.

  From the start of sedation to end of endoscopy (typically 5-20 minutes)

Secondary Outcomes (7)

• Incidence of hypoxemia

  During endoscopic procedure (from sedation start to endoscope removal)

• Number of hypoxemic episodes

  During endoscopic procedure

• Duration of hypoxemia (in seconds)

  During endoscopic procedure

• Airway interventions

  During endoscopic procedure

• Hemodynamic complications

  During endoscopic procedure

Study Arms (2)

Group P

EXPERIMENTAL

Oxygen delivered via Procedural Oxygen Mask (POM™) at a fixed flow of 15 L/min (approx. FiO₂ 95%) throughout the procedure.

Device: Procedural Oxygen Mask

Group H

ACTIVE COMPARATOR

Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.

Device: High-Flow Nasal Cannula

Interventions

Procedural Oxygen Mask DEVICE

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

Group P

High-Flow Nasal Cannula DEVICE

Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.

Group H

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bedirhan Günel: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bedirhan Günel, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bedirhan Günel, MD

CONTACT

5069647656; bedirhangunel71@gmail.com

Mehmet Yilmaz, Ass. Prof.

CONTACT

505 217 44 32; drmyilmaz33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: March 4, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)