Pediatric Sedation
Conditions
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.
Interventions
DEVICEhigh 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%.
DEVICEnasal prong
Oxygen is administered via nasal prong
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desaturation (≤95%) | through study completion, average 30 minutes | Occurrence of desaturation (pulse oximeter ≤95%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Desaturation (≤90%) | through study completion, average 30 minutes | Occurrence of desaturation (pulse oximeter ≤90%) |
| CO2 value | through study completion, average 30 minutes | percutaneous CO2 (maximum, minimum, mean values) |
| Minimum saturation during sedation | through study completion, average 30 minutes | — |
| Complications | through study completion, average 30 minutes | Any complications during sedation |
Countries
South Korea
Contacts
Primary ContactJin-Tae Kim, MD, PhD
Outcome results
None listed