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

Pediatric Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852432
• Other study ID #: H2103-095-1205
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Seoul National University Hospital
• Contact: Jin-Tae Kim, MD, PhD
• Phone: 02-2072-3661
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: December 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Sedation

Intervention

Device:
• high 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%.
• nasal prong
Oxygen is administered via nasal prong

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desaturation (=95%)	Occurrence of desaturation (pulse oximeter =95%)	through study completion, average 30 minutes
Secondary	Desaturation (=90%)	Occurrence of desaturation (pulse oximeter =90%)	through study completion, average 30 minutes
Secondary	CO2 value	percutaneous CO2 (maximum, minimum, mean values)	through study completion, average 30 minutes
Secondary	Minimum saturation during sedation		through study completion, average 30 minutes
Secondary	Complications	Any complications during sedation	through study completion, average 30 minutes