A new clinical trial aims to compare the safety and effectiveness of procedural oxygen masks against nasal cannulas in addressing hypoxemia during pediatric endoscopy. The trial, sponsored by Bedirhan Günel, is not yet recruiting participants, but its outcomes could provide vital insights for clinical teams working with children requiring respiratory support during procedures.
In this article:
- What is the design of the clinical trial?
- What devices are being studied?
- What are the regulatory and clinical implications?
- Frequently Asked Questions
- Summary and key takeaways
- Disclaimer
- Reference and link
What is the design of the clinical trial?
The trial focuses on reducing hypoxemia—a condition where blood oxygen levels drop dangerously low—often a concern during pediatric endoscopy. According to the ClinicalTrials.gov record dated November 18, 2025, this study will compare two oxygen delivery devices in a controlled clinical setting.
Recruitment has not yet begun, and further details about enrollment criteria, endpoints, and methodology await clarification. Future updates are anticipated to refine these aspects.
What devices are being studied?
The study will assess two devices for oxygen delivery:
- Procedural Oxygen Mask: A device providing targeted oxygen delivery with potentially higher efficacy for maintaining stable respiratory functions during endoscopic procedures.
- Nasal Cannula: A widely-used device offering continuous oxygen flow via nasal prongs, valued for its comfort and familiarity in clinical settings.
Both devices will be evaluated based on their performance in alleviating hypoxemia, patient safety profiles, and overall usability during pediatric endoscopy.
What are the regulatory and clinical implications?
This trial, once completed, could influence device selection guidelines for pediatric endoscopic procedures. Clinical insights from this study may aid decision-making in ensuring better patient outcomes while adhering to medical device regulation standards such as MDR Annex XIV.
Medical device manufacturers, regulators, and healthcare institutions can utilize the outcomes to bolster compliance and optimize respiratory care pathways. Pediatric specialists might also find the results pivotal in determining device appropriateness based on age-specific and procedural needs.
Frequently Asked Questions
1. When will the trial start recruiting participants?
The trial status is listed as “not yet recruiting” as of November 2025. Updates will announce open recruitment phases.
2. Where can more details be found?
The study is registered on ClinicalTrials.gov under the identifier NCT07234175.
3. Who is sponsoring the study?
The trial sponsor is Bedirhan Günel.
4. Why is hypoxemia a major concern in pediatric endoscopy?
Hypoxemia can lead to severe complications, especially in younger patients who are undergoing invasive procedures where stable oxygen levels are critical.
Summary and key takeaways
The forthcoming trial comparing procedural oxygen masks and nasal cannulas could provide game-changing insights for respiratory care in pediatric endoscopy. Clinical and regulatory teams should monitor updates closely as recruitment begins to understand how these devices impact hypoxemia management.
Disclaimer
This article is intended for informational purposes for clinical and regulatory professionals. It is not legal or medical advice and does not replace direct consultation with regulatory or healthcare authorities.
Reference and link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07234175?term=medical+device