Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Apnea success rate
Study Overview
Brief Summary
This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.
Detailed Description
This is a prospective randomized controlled trial comparing two oxygenation methods for prolongation of apnea time in children aged 0 to 10 years old.
This study measures time for the pulse oximetry drop from 100% to 92% after oxygenation with 100% oxygen, applying high flow nasal cannula or buccal oxygen insufflation via an oral Ring-Adair-Elwyn endotracheal tube connected to oxygen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children under 11 years old undergoing general anesthesia with American Society of Anesthesiologists Physical Status 1 or 2.
Exclusion Criteria
- •Refusal of enrollment from one or more legal guardians of the patient
- •Plan of usage of supraglottic airway device as airway maintenance device
- •Presence of upper respiratory tract infection of lung disease
- •Premature infants younger than postconceptual age of 40 weeks
- •Anticipation of difficult bag-mask ventilation due to facial anomaly or micrognathia
- •Other conditions that are considered inappropriate for the study
Arms & Interventions
High flow
Application of high flow nasal cannula during apnea
Intervention: High flow nasal cannula (Device)
Buccal
Application of buccal oxygenation during apnea
Intervention: Buccal oxygenation (Device)
Outcomes
Primary Outcomes
Apnea success rate
Time Frame: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Proportion of patients that succeed in prolongation of apnea time while maintaining pulse oximetry \> 92%
Secondary Outcomes
- End-tidal carbon dioxide(After resuming of bag-mask ventilation, up to 30 seconds)
- Pulse oximetry(From start of study to end of study, up to 20 min)
- Apnea time(From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds)
- Time to pulse oximetry of 100 percent(After resuming of bag-mask ventilation, up to 300 seconds)
- Minimal pulse oximetry(After resuming of bag-mask ventilation, up to 60 seconds)
- Electrocardiogram(From start of study to end of study, up to 20 min)
- Mean blood pressure(From start of study to end of study, up to 20 min)
- Oxygen reserve index(From start of study to end of study, up to 20 min)
- Transcutaneous carbon dioxide(From start of study to end of study, up to 20 min)
- Heart rate(From start of study to end of study, up to 20 min)
Investigators
Jin-Tae Kim
MD, PhD, Professor
Seoul National University Hospital