High Flow Nasal Cannula for Safe Apnea

Not Applicable

Completed

• Conditions: Anesthesia, General; Apnea
• Interventions: Device: Buccal oxygenation; Device: High flow nasal cannula

• Registration Number: NCT04849520
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Study Start: 2021-08-12
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buccal	Buccal oxygenation	Application of buccal oxygenation during apnea
High flow	High flow nasal cannula	Application of high flow nasal cannula during apnea

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Pulse oximetry	From start of study to end of study, up to 20 min	Pulse oximetry 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
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
Minimal pulse oximetry	After resuming of bag-mask ventilation, up to 60 seconds	Lowest value of pulse oximetry after resume of bag-mask ventilation
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
Mean blood pressure	From start of study to end of study, up to 20 min	Mean non-invasive blood pressure 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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of