Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-02-02
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group P
Oxygen delivered via Procedural Oxygen Mask (POM™) at a fixed flow of 15 L/min (approx. FiO₂ 95%) throughout the procedure.
Procedural Oxygen Mask
Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.
Group H
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.
High-Flow Nasal Cannula
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.
Interventions
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Procedural Oxygen Mask
Delivers oxygen through the mouth and nose during sedation while allowing endoscope passage.
High-Flow Nasal Cannula
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
16 Years
ALL
No
Sponsors
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Bedirhan Günel
OTHER_GOV
Responsible Party
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Bedirhan Günel
Principal Investigator
Principal Investigators
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Bedirhan Günel, MD
Role: PRINCIPAL_INVESTIGATOR
Kocaeli City Hospital
Locations
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Kocaeli City Hospital
Kocaeli, Izmit, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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MEHMET YILMAZ, Assoc. Prof.
Role: primary
Other Identifiers
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KSH-ANREA-BG-09
Identifier Type: -
Identifier Source: org_study_id