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

Not Applicable

• Conditions: Desaturation
• Interventions: Device: High flow nasal cannula

• Registration Number: NCT04152733
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-03
• Study First Posted: 2019-11-05
• Study Start: 2020-03-23
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22
• Primary Completion: 2021-11-20
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow (HF) group	High flow nasal cannula	Children in the HF group receive oxygen via high flow nasal cannula during deep sedation. Fraction of inspired oxygen is set to 50%.

Primary Outcome Measures

Name	Time	Method
Incidence of desaturation	During deep sedation (during approximately 1 hour after propofol infusion)	Incidence of peripheral pulse oximeter value lower than 95%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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