Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients
1 other identifier
interventional
258
1 country
1
Brief Summary
The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedStudy Start
First participant enrolled
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedFebruary 23, 2024
February 1, 2024
2.8 years
April 15, 2021
February 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Desaturation (≤95%)
Occurrence of desaturation (pulse oximeter ≤95%)
through study completion, average 30 minutes
Secondary Outcomes (4)
Desaturation (≤90%)
through study completion, average 30 minutes
CO2 value
through study completion, average 30 minutes
Minimum saturation during sedation
through study completion, average 30 minutes
Complications
through study completion, average 30 minutes
Study Arms (3)
Control group
NO INTERVENTIONNasal prong is applied, but sedation is performed without oxygen administration.
Low flow group
EXPERIMENTALOxygen administration by nasal cannula
High flow group
EXPERIMENTALOxygen is administered at a rate of 2L/kg/min using an Optiflow device
Interventions
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%.
Eligibility Criteria
You may qualify if:
- Children under the age of 18 who undergo moderate-deep sedation
You may not qualify if:
- Respiratory failure patients
- Increased intracranial pressure
- Recent massive nasal bleeding
- History of airway surgery
- Complete nasal obstruction
- Pulmonary hypertension
- Skull base fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 40215365DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 15, 2021
First Posted
April 21, 2021
Study Start
July 27, 2021
Primary Completion
April 30, 2024
Study Completion
December 30, 2024
Last Updated
February 23, 2024
Record last verified: 2024-02