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

Status: Enrolling

Conditions: Pediatric Sedation

Treatments: Device: high flow nasal cannula; Device: nasal prong

Study type: Interventional

Funder types: Other

Identifiers

NCT04852432

H2103-095-1205

Details and patient eligibility

About

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.

Enrollment: 258 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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258 participants in 3 patient groups

Control group

No Intervention group

Description:

Nasal prong is applied, but sedation is performed without oxygen administration.

Low flow group

Experimental group

Description:

Oxygen administration by nasal cannula

Treatment:

Device: nasal prong

High flow group

Experimental group

Description:

Oxygen is administered at a rate of 2L/kg/min using an Optiflow device

Treatment:

Device: high flow nasal cannula