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

• 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

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
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
Desaturation (≤90%)	through study completion, average 30 minutes	Occurrence of desaturation (pulse oximeter ≤90%)

Trial Locations

Locations (1)

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