Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients
NCT ID: NCT04852432
Last Updated: 2024-02-23
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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RECRUITING
NA
258 participants
INTERVENTIONAL
2021-07-27
2024-12-30
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
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Control group
Nasal prong is applied, but sedation is performed without oxygen administration.
No interventions assigned to this group
Low flow group
Oxygen administration by nasal cannula
nasal prong
Oxygen is administered via nasal prong
High flow group
Oxygen is administered at a rate of 2L/kg/min using an Optiflow device
high flow nasal cannula
The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.
Interventions
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high flow nasal cannula
The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.
nasal prong
Oxygen is administered via nasal prong
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Increased intracranial pressure
* Recent massive nasal bleeding
* History of airway surgery
* Complete nasal obstruction
* Pulmonary hypertension
* Skull base fracture
17 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin-Tae Kim
Professor
Principal Investigators
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Jin-Tae Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Lee JH, Ko HJ, Park JB, Ji SH, Kim JT. Oxygen Supplementation in Pediatric Sedation: Prospective, Multicenter, Randomized Controlled Trial. Anesthesiology. 2025 Jul 1;143(1):132-141. doi: 10.1097/ALN.0000000000005500. Epub 2025 Apr 11.
Other Identifiers
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H2103-095-1205
Identifier Type: -
Identifier Source: org_study_id
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