Anesthesia, General, Apnea
Conditions
Keywords
Oxygenation, High-flow nasal cannula
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.
Interventions
DEVICEHigh flow nasal cannula
Oxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min
DEVICEBuccal oxygenation
Oxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min
Sponsors
National Evidence-Based Healthcare Collaborating Agency
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea success rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Pulse oximetry | From start of study to end of study, up to 20 min | Pulse oximetry measured throughout the study |
| Oxygen reserve index | From start of study to end of study, up to 20 min | Oxygen reserve index measured throughout the study |
| Apnea time | From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds | Time elapsed from start of apnea to resume of bag-mask ventilation |
| End-tidal carbon dioxide | After resuming of bag-mask ventilation, up to 30 seconds | End-tidal carbon dioxide partial pressure of first resumed breath after apnea |
| Mean blood pressure | From start of study to end of study, up to 20 min | Mean non-invasive blood pressure measured throughout the study |
| Time to pulse oximetry of 100 percent | After resuming of bag-mask ventilation, up to 300 seconds | Time elapsed from resume of bag-mask ventilation to regain of 100 percent in the pulse oximetry value |
| Electrocardiogram | From start of study to end of study, up to 20 min | Appearance of any arrhythmia or prolonged QT interval measured throughout the study |
| Transcutaneous carbon dioxide | From start of study to end of study, up to 20 min | Transcutaneous carbon dioxide level measured throughout the study |
| Heart rate | From start of study to end of study, up to 20 min | Heart rate measured throughout the study |
| Minimal pulse oximetry | After resuming of bag-mask ventilation, up to 60 seconds | Lowest value of pulse oximetry after resume of bag-mask ventilation |
Countries
South Korea
Outcome results
None listed