Procedural Oxygen Mask vs Nasal Cannula in Pediatric Endoscopy

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 114
• 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; Participants will receive oxygen via a Procedural Oxygen Mask (POM) at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation.	Device: Procedural Oxygen Mask; Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.
Active Comparator: 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.	Device: Nasal Cannula; Provides standard oxygen delivery through the nostrils during sedation.

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Actual): March 3, 2026
• Study Completion (Actual): March 3, 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): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 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; Equipment and Supplies; Catheters; Cannula
• Other Study ID Numbers: KSH-ANREA-BG-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be made available 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