Procedural oxygen mask versus high-flow nasal cannula to prevent low oxygen in children during upper GI endoscopy
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
NA · Kocaeli City Hospital · NCT07234188
This trial will test whether a procedural oxygen mask or a high-flow nasal cannula better prevents low oxygen levels in children aged 6 to 16 having sedated upper gastrointestinal endoscopy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | Kocaeli City Hospital (other gov) |
| Locations | 1 site (Kocaeli, Izmit) |
| Trial ID | NCT07234188 on ClinicalTrials.gov |
What this trial studies
This randomized pilot compares the procedural oxygen mask (POM™) with high-flow nasal cannula (HFNC) for preventing hypoxemia during sedated pediatric upper gastrointestinal endoscopy. Children aged 6–16 years, weighing more than 30 kg and classified as ASA I–II, who are scheduled for non-emergency procedures will be randomized to receive oxygen via POM or HFNC. Investigators will continuously monitor oxygen saturation and record desaturation events, airway interventions, and other safety outcomes during the procedure. The single-center trial at Kocaeli City Hospital aims to generate preliminary data to inform larger studies on optimal oxygen delivery in this setting.
Who should consider this trial
Good fit: Children aged 6–16 years, over 30 kg, ASA physical status I–II, scheduled for non-emergency sedated upper GI endoscopy with parental consent are the intended participants.
Not a fit: Children with known pulmonary or cardiac disease, oxygen dependency, recent intubation/ICU admission, tracheostomy, congenital airway or craniofacial anomalies, or those outside the age/weight criteria are excluded and likely will not benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could reduce episodes of low oxygen during pediatric endoscopy and improve procedural safety by identifying the more effective oxygen delivery method.
How similar studies have performed: High-flow nasal cannula has shown reductions in desaturation in several pediatric respiratory and procedural settings, while randomized data on procedural oxygen masks specifically for pediatric endoscopy are limited, making this comparison partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kocaeli, Izmit
- Kocaeli City Hospital — Kocaeli, Izmit, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Bedirhan Günel, MD — Kocaeli City Hospital
- Study coordinator: Bedirhan Günel, MD
- Email: bedirhangunel71@gmail.com
- Phone: 5069647656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoxemia