NCT04852432RecruitingNot Applicable
Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients
Seoul National University Hospital2 sites in 2 countries258 target enrollmentStarted: July 27, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 258
- Locations
- 2
- Primary Endpoint
- Desaturation (≤95%)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children under the age of 18 who undergo moderate-deep sedation
Exclusion Criteria
- •Respiratory failure patients
- •Increased intracranial pressure
- •Recent massive nasal bleeding
- •History of airway surgery
- •Complete nasal obstruction
- •Pulmonary hypertension
- •Skull base fracture
Arms & Interventions
Low flow group
Experimental
Oxygen administration by nasal cannula
Intervention: nasal prong (Device)
High flow group
Experimental
Oxygen is administered at a rate of 2L/kg/min using an Optiflow device
Intervention: high flow nasal cannula (Device)
Control group
No Intervention
Nasal prong is applied, but sedation is performed without oxygen administration.
Outcomes
Primary Outcomes
Desaturation (≤95%)
Time Frame: through study completion, average 30 minutes
Occurrence of desaturation (pulse oximeter ≤95%)
Secondary Outcomes
- 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)
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital
Study Sites (2)
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