POM vs HFNC for Hypoxemia Prevention in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-02

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group P

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

Group Type EXPERIMENTAL

Procedural Oxygen Mask

Intervention Type DEVICE

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

Group H

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

Group Type ACTIVE_COMPARATOR

High-Flow Nasal Cannula

Intervention Type DEVICE

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

Interventions

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Procedural Oxygen Mask

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

Intervention Type DEVICE

High-Flow Nasal Cannula

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

Intervention Type DEVICE

Eligibility Criteria

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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