Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures

Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures: a Randomized Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Disorder
• Intervention / Treatment: Device: High flow; Device: Low Flow

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Huang, MD; Phone Number: (713) 500-5419; Email: Zhen.J.Huang@uth.tmc.edu
• Study Contact Backup: Name: Candace Hernandez; Phone Number: (713) 500-5410; Email: Candace.Hernandez@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Candace Hernandez; Phone Number: (713) 500-5410; Email: Candace.Hernandez@uth.tmc.edu
      • Contact: Zhen Huang, MD; Phone Number: 713-500-5419; Email: Zhen.J.Huang@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Emergency type cases, tracheostomy patients, unrepaired cyanotic heart disease, nasal deformity/choanal atresia, or cautery/laser type procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High flow	Device: High flow; The High Flow Nasal Cannula (HFNC) device (Vapotherm) will be placed through the nostrils for oxygen (2L/kg per min with max of 45L)
Experimental: Low Flow	Device: Low Flow; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants that show an incidence of oxygen desaturation >5 %	from start of procedure to end of procedure (about 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Number of surgical interruptions due to desaturation defined by a pause in surgical procedures due to need to provide airway intervention to improve patient's oxygen saturation, normalized to case length. Airway interventions may include LMA, bag mask ventilation, and/or endotracheal intubations	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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Zhen Huang, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: High Flow Nasal Cannula (HFNC)
• Other Study ID Numbers: HSC-MS-25-0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No