Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06947902

Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Airway Disorder

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High flow

Device

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 Flow

Device

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 outcomes

  1. 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 outcomes

  1. Apnea time measured in seconds or minutes

    Time frame: from start of procedure to end of procedure (about 1 hour)

  2. Number of Participants With Surgical Interruptions Due to Desaturation

    Time frame: 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

  3. Oxygen nadir level

    Time frame: from start of procedure to end of procedure (about 1 hour)

  4. Transcutaneous CO2 measurements throughout procedure

    Time frame: from start of procedure to end of procedure (about 1 hour)

  5. Adverse events related to device itself (nasal pain, skin irritation)

    Time frame: from baseline to end of study (1 month after baseline)

Study contacts

Contact information is provided by the study sponsor or research team.

Candace Hernandez

CONTACT

[email protected]

(713) 500-5410

Zhen Huang, MD

CONTACT

[email protected]

(713) 500-5419

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.