Hypoxemia
Conditions
Brief summary
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.
Interventions
DEVICEProcedural Oxygen Mask
Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.
DEVICEHigh-Flow Nasal Cannula
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.
Sponsors
Bedirhan Günel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest SpO₂ level during procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxemia | 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. |
| Number of hypoxemic episodes | During endoscopic procedure | Recurrent desaturations: counted when SpO₂ falls \<94% again, at least 30 seconds after a return to ≥94%. |
| Duration of hypoxemia (in seconds) | During endoscopic procedure | Time required for SpO₂ to return to ≥94% after each episode of desaturation (\<94%). |
| Airway interventions | During endoscopic procedure | Number of occurrences requiring airway maneuvers (chin lift, jaw thrust, or mask ventilation). |
| Hemodynamic complications | During endoscopic procedure | Incidence of hypotension (\>20% drop from baseline systolic BP), hypertension (\>20% increase), bradycardia or tachycardia per age-specific thresholds. |
| Gastroenterologist satisfaction score | During endoscopic procedure | Rated from 0 (poor sedation, interrupted) to 10 (optimal sedation). |
| Incidence of Device Repositioning | During endoscopic procedure | Adjustment of POM™ or HFNC due to displacement, leakage, or malfunction. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBedirhan Günel, MD
CONTACTMehmet Yilmaz, Ass. Prof.
PRINCIPAL_INVESTIGATORBedirhan Günel, MD
Kocaeli City Hospital
Outcome results
None listed