Procedural Oxygen Mask vs Nasal Cannula in Pediatric Endoscopy

NCT07234175 | Completed

• 1 other identifier: KSH-ANREA-BG-08
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

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 (6)

• 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

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

Group N

ACTIVE COMPARATOR

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

Interventions

Procedural Oxygen Mask DEVICE

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

Group P

Nasal Cannula DEVICE

Provides standard oxygen delivery through the nostrils during sedation.

Group N

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)

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Cannula

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Bedirhan Günel, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

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: November 20, 2025
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)