Airway DisorderNCT06947902
Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures
A study testing High flow and Low Flow in people with Airway Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Airway Disorder
- What is being tested?
- High flow and Low Flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Emergency type cases, tracheostomy patients, unrepaired cyanotic heart disease, nasal deformity/choanal atresia, or cautery/laser type procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Zhen Huang, MD, 713-500-5419, Zhen.J.Huang@uth.tmc.edu
Candace Hernandez, (713) 500-5410, Candace.Hernandez@uth.tmc.edu
About this study
Official title: 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
- Conditions
- Airway Disorder
- Being tested
- High flow, Low Flow
- Keywords
- High Flow Nasal Cannula (HFNC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flowDevice
The High Flow Nasal Cannula (HFNC) device (Vapotherm) will be placed through the nostrils for oxygen (2L/kg per min with max of 45L)
Low FlowDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| High flow | Experimental | Not described Receives: Device: High flow |
| Low Flow | Experimental | Not described Receives: Device: Low Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that show an incidence of oxygen desaturation >5 %
Measured: from start of procedure to end of procedure (about 1 hour)
Secondary outcomes (5)
Apnea time measured in seconds or minutes
Measured: 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
Measured: from start of procedure to end of procedure (about 1 hour)
Oxygen nadir level
Measured: from start of procedure to end of procedure (about 1 hour)
Transcutaneous CO2 measurements throughout procedure
Measured: from start of procedure to end of procedure (about 1 hour)
Adverse events related to device itself (nasal pain, skin irritation)
Measured: from baseline to end of study (1 month after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Huang, The University of Texas Health Science Center, Houston
- Investigators
- Zhen Huang, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947902
- Sponsor's protocol ID
- HSC-MS-25-0028
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures: a Randomized Study
- ClinicalTrials.gov ID
- NCT06947902
- Acronym / sponsor ID
- HSC-MS-25-0028
- Conditions
- Airway Disorder
- Keywords
- High Flow Nasal Cannula (HFNC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow | Experimental | Device: High flow |
| Low Flow | Experimental | Device: Low Flow |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Emergency type cases, tracheostomy patients, unrepaired cyanotic heart disease, nasal deformity/choanal atresia, or cautery/laser type procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flowThe High Flow Nasal Cannula (HFNC) device (Vapotherm) will be placed through the nostrils for oxygen (2L/kg per min with max of 45L) | Device | High flow |
| Low FlowThe High Flow Nasal Cannula (HFNC) device (Vapotherm) will be placed through the nostrils for oxygen (0.5L/kg per min with max of 5L) | Device | Low Flow |
Primary outcome
Number of participants that show an incidence of oxygen desaturation >5 %
Time frame: from start of procedure to end of procedure (about 1 hour)
5 secondary outcomes
Apnea time measured in seconds or minutes
Time frame: from start of procedure to end of procedure (about 1 hour)
Number of Participants With Surgical Interruptions Due to Desaturation
Time frame: from start of procedure to end of procedure (about 1 hour)
Oxygen nadir level
Time frame: from start of procedure to end of procedure (about 1 hour)
Transcutaneous CO2 measurements throughout procedure
Time frame: from start of procedure to end of procedure (about 1 hour)
Adverse events related to device itself (nasal pain, skin irritation)
Time frame: from baseline to end of study (1 month after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhen Huang, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow and Low Flow in people with Airway Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Huang, MD ((713) 500-5419, Zhen.J.Huang@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that show an incidence of oxygen desaturation >5 % (time frame: from start of procedure to end of procedure (about 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.