POM vs HFNC for Hypoxemia Prevention in Children

N/ANot Yet RecruitingNCT07234188

Bedirhan Günel30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hypoxemia

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Incidence of hypoxemia

Defined as any drop in SpO₂ \<94% lasting for at least 10 seconds. Based on pulse oximetry recordings.

Time frame: 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%.