Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population

Desaturation Clinical Trial

Official title:

Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04152733
• Other study ID #: H1910-038-1068
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2020
• Source: Seoul National University Hospital
• Contact: Jin-Tae Kim, MD, PhD
• Phone: 82-2-2072-3661
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 30, 2021
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

• Children aged <7 years

• ASA class I, II

Exclusion Criteria:

• Respiratory disease

• Pneumothorax

• Increased ICP

• Nasal bleeding

• Previous airway surgery

• Trauma

• Pulmonary hypertension

Related Conditions & MeSH terms

• Desaturation

Intervention

Device:
• High flow nasal cannula
Oxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand).

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	Incidence of desaturation	Incidence of peripheral pulse oximeter value lower than 95%	During deep sedation (during approximately 1 hour after propofol infusion)
Secondary	Minimum pulse oximeter value		During deep sedation (during approximately 1 hour after propofol infusion)
Secondary	Incidence of peripheral pulse oximeter value lower than 90%		During deep sedation (during approximately 1 hour after propofol infusion)
Secondary	Incidence of changes in oxygen flow (control group) or FiO2 (HF group)		During deep sedation (during approximately 1 hour after propofol infusion)
Secondary	percutaneous CO2 value		During deep sedation (during approximately 1 hour after propofol infusion)
Secondary	Oxygen reserve index value		During deep sedation (during approximately 1 hour after propofol infusion)
Secondary	Incidence of manual ventilation		During deep sedation (during approximately 1 hour after propofol infusion)