Kocaeli City Hospital
Kocaeli, Izmit, 41100, Turkey (Türkiye)
NCT Number: NCT07234175
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.
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Notify Me6 year–16 year
All sexes
Interventional
Not applicable
Kocaeli, Izmit, 41100, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.
Provides standard oxygen delivery through the nostrils during sedation.
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.
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.
Time frame: During endoscopic procedure
Recurrent desaturations: counted when SpO₂ falls <94% again, at least 30 seconds after a return to ≥94%.
Time frame: During endoscopic procedure
Time required for SpO₂ to return to ≥94% after each episode of desaturation (<94%).
Time frame: During endoscopic procedure
Number of occurrences requiring airway maneuvers (chin lift, jaw thrust, or mask ventilation).
Time frame: During endoscopic procedure
Incidence of hypotension (>20% drop from baseline systolic BP), hypertension (>20% increase), bradycardia or tachycardia per age-specific thresholds.
Time frame: During endoscopic procedure
Rated from 0 (poor sedation, interrupted) to 10 (optimal sedation).
Bedirhan Günel
Other Gov
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
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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