Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to investigate which flow rate (higher versus lower) is most effective at increasing apneic time and preventing greater than 5% drop in desaturation, as well as assessing transcutaneous carbon dioxide (CO2) levels during airway procedures in children
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 Aug 2025
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
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
April 27, 2025
April 1, 2025
2.1 years
April 17, 2025
April 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants that show an incidence of oxygen desaturation >5 %
from start of procedure to end of procedure (about 1 hour)
Secondary Outcomes (5)
Apnea time measured in seconds or minutes
from start of procedure to end of procedure (about 1 hour)
Number of Participants With Surgical Interruptions Due to Desaturation
from start of procedure to end of procedure (about 1 hour)
Oxygen nadir level
from start of procedure to end of procedure (about 1 hour)
Transcutaneous CO2 measurements throughout procedure
from start of procedure to end of procedure (about 1 hour)
Adverse events related to device itself (nasal pain, skin irritation)
from baseline to end of study (1 month after baseline)
Study Arms (2)
High flow
EXPERIMENTALLow Flow
EXPERIMENTALInterventions
The High Flow Nasal Cannula (HFNC) device (Vapotherm) will be placed through the nostrils for oxygen (2L/kg per min with max of 45L)
The High Flow Nasal Cannula (HFNC) device (Vapotherm) will be placed through the nostrils for oxygen (0.5L/kg per min with max of 5L)
Eligibility Criteria
You may qualify if:
- undergoing laryngoscopy and bronchoscopy procedures at Children's Memorial Hermann Hospital (CMHH)
- weight greater than or equal to 5 kilograms and using flow rates between 5 to 45 liters per minute (BTPS)
You may not qualify if:
- Emergency type cases, tracheostomy patients, unrepaired cyanotic heart disease, nasal deformity/choanal atresia, or cautery/laser type procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Zhen Huang, MD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 17, 2025
First Posted
April 27, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share