POM vs HFNC for Hypoxemia Prevention in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemia
• Intervention / Treatment: Device: Procedural Oxygen Mask; Device: High-Flow Nasal Cannula

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmit
    • Kocaeli, Izmit, Turkey (Türkiye), 41100
      • Kocaeli City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group P; 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; Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.
Active Comparator: Group H; Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.	Device: High-Flow Nasal Cannula; Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxemia	Defined as any drop in SpO₂ <94% lasting for at least 10 seconds. Based on pulse oximetry recordings.	During endoscopic procedure (from sedation start to endoscope removal)
Number of hypoxemic episodes	Recurrent desaturations: counted when SpO₂ falls <94% again, at least 30 seconds after a return to ≥94%.	During endoscopic procedure
Duration of hypoxemia (in seconds)	Time required for SpO₂ to return to ≥94% after each episode of desaturation (<94%).	During endoscopic procedure
Airway interventions	Number of occurrences requiring airway maneuvers (chin lift, jaw thrust, or mask ventilation).	During endoscopic procedure
Hemodynamic complications	Incidence of hypotension (>20% drop from baseline systolic BP), hypertension (>20% increase), bradycardia or tachycardia per age-specific thresholds.	During endoscopic procedure
Gastroenterologist satisfaction score	Rated from 0 (poor sedation, interrupted) to 10 (optimal sedation).	During endoscopic procedure
Incidence of Device Repositioning	Adjustment of POM™ or HFNC due to displacement, leakage, or malfunction.	During endoscopic procedure

Collaborators and Investigators

• Sponsor: Bedirhan Günel
• Investigators: Principal Investigator: Bedirhan Günel, MD, Kocaeli City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Actual): May 21, 2026
• Study Completion (Actual): May 21, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia
• Other Study ID Numbers: KSH-ANREA-BG-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No