Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients

Not Applicable

Recruiting

• Conditions: Pediatric Sedation
• Interventions: Device: high flow nasal cannula; Device: nasal prong

• Registration Number: NCT04852432
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-15
• Study First Posted: 2021-04-21
• Study Start: 2021-07-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow group	high flow nasal cannula	Oxygen is administered at a rate of 2L/kg/min using an Optiflow device
Low flow group	nasal prong	Oxygen administration by nasal cannula

Primary Outcome Measures

Name	Time	Method
Desaturation (≤95%)	through study completion, average 30 minutes	Occurrence of desaturation (pulse oximeter ≤95%)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of