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Completed

NCT Number: NCT07234188

POM vs HFNC for Hypoxemia Prevention in Children

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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Key information

Conditions

Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procedural Oxygen Mask

Device

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

High-flow nasal cannula

Device

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

Primary outcomes

  1. Lowest SpO₂ level during procedure

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

    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.

Secondary outcomes

  1. Incidence of hypoxemia

    Time frame: During endoscopic procedure (from sedation start to endoscope removal)

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

  2. Number of hypoxemic episodes

    Time frame: During endoscopic procedure

    Recurrent desaturations: counted when SpO₂ falls <94% again, at least 30 seconds after a return to ≥94%.

  3. Duration of hypoxemia (in seconds)

    Time frame: During endoscopic procedure

    Time required for SpO₂ to return to ≥94% after each episode of desaturation (<94%).

  4. Airway interventions

    Time frame: During endoscopic procedure

    Number of occurrences requiring airway maneuvers (chin lift, jaw thrust, or mask ventilation).

  5. Hemodynamic complications

    Time frame: During endoscopic procedure

    Incidence of hypotension (>20% drop from baseline systolic BP), hypertension (>20% increase), bradycardia or tachycardia per age-specific thresholds.

  6. Gastroenterologist satisfaction score

    Time frame: During endoscopic procedure

    Rated from 0 (poor sedation, interrupted) to 10 (optimal sedation).

  7. Incidence of Device Repositioning

    Time frame: During endoscopic procedure

    Adjustment of POM™ or HFNC due to displacement, leakage, or malfunction.

Sponsors and collaborators

Lead sponsor

Bedirhan Günel

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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