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Not yet recruiting NCT06947902

Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures

No phase Interventional Airway Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High flow, Low Flow.
Who it may be relevant to
Registry conditions: Airway Disorder. Basic parameters: 0 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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)
  • 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)

Primary outcome measures

  • Number of participants that show an incidence of oxygen desaturation >5 % [Time frame: from start of procedure to end of procedure (about 1 hour)]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06947902 · HSC-MS-25-0028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗