Airway Disorder
Conditions
Keywords
High Flow Nasal Cannula (HFNC)
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
Interventions
DEVICEHigh 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)
DEVICELow 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)
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 |
| 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) | — |
Countries
United States
Contacts
Primary ContactZhen Huang, MD
Backup ContactCandace Hernandez
Outcome results
None listed