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Safety Analysis of Pharyngeal Oxygenation Device versus Face Mask Oxygenation in Pediatric Fiberoptic Endoscopy Procedures

Safety Analysis of Pharyngeal Oxygenation Device versus Face Mask Oxygenation in Pediatric Fiberoptic Endoscopy Procedures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113734
Enrollment
Unknown
Registered
2025-12-02
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory diseases

Interventions

Experimental group (mask oxygen group or new nasal catheter (throat) oxygen):Oxygen inhalation via face mask or throat
Control group:None

Sponsors

Bishan District People's Hospital of Chongqing City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 15 Years

Inclusion criteria

Inclusion criteria: 1.age 0–15 years; 2.American Society of Anesthesiologists (ASA) physical status classification I or II; 3.scheduled for elective flexible bronchoscopy; 4.written informed consent provided by legal guardians.

Exclusion criteria

Exclusion criteria: 1. known or anticipated difficult airway; 2. severe cardiac or pulmonary insufficiency; 3. active upper respiratory or nasal bleeding; 4. craniofacial abnormalities that compromise mask sealing or nasal cannula placement; 5. documented hypersensitivity to components of the study devices or administered medications.

Design outcomes

Primary

MeasureTime frame
Intraoperative oxygen saturation;

Secondary

MeasureTime frame
The time of the first occurrence of hypoxemia;The incidence of severe intraoperative hypoxemia;The satisfaction of bronchoscopists with the field of vision and the interference of the oxygen supply device;The number of times that mask ventilation was required to be paused due to a decrease in blood oxygen saturation.;The lowest blood oxygen saturation value during the operation;

Countries

China

Contacts

Public ContactChen Jun

Bishan District People's Hospital of Chongqing City

1136234574@qq.com+86 23 41411848

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 29, 2026