Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population
1 other identifier
interventional
82
1 country
1
Brief Summary
To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedStudy Start
First participant enrolled
March 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedApril 22, 2020
April 1, 2020
1.7 years
November 3, 2019
April 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of desaturation
Incidence of peripheral pulse oximeter value lower than 95%
During deep sedation (during approximately 1 hour after propofol infusion)
Secondary Outcomes (6)
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)
percutaneous CO2 value
During deep sedation (during approximately 1 hour after propofol infusion)
Oxygen reserve index value
During deep sedation (during approximately 1 hour after propofol infusion)
- +1 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONChildren in the control group receive oxygen via conventional nasal cannula during deep sedation. Oxygen flow is determined to set the fraction of inspired oxygen of 50%.
High flow (HF) group
EXPERIMENTALChildren in the HF group receive oxygen via high flow nasal cannula during deep sedation. Fraction of inspired oxygen is set to 50%.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Children aged \<7 years
- ASA class I, II
You may not qualify if:
- Respiratory disease
- Pneumothorax
- Increased ICP
- Nasal bleeding
- Previous airway surgery
- Trauma
- Pulmonary hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 3, 2019
First Posted
November 5, 2019
Study Start
March 23, 2020
Primary Completion
November 20, 2021
Study Completion
December 30, 2021
Last Updated
April 22, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share