High-flow Nasal Cannula for Pediatric Anesthetic Induction

Not Applicable

Not yet recruiting

• Conditions: Oxygen Deficiency
• Interventions: Procedure: face mask; Procedure: high flow nasal oxygen

• Registration Number: NCT05578131
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Endotracheal intubation in infants often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in infants receiving general anesthesia, can decrease the occurence of desaturation during intubation.

The investigators tested the hypothesis that high-flow nasal oxygen cannulae would be effective in maintaining oxygen saturation during intubation than facemasks for pre-oxygenation. The investigators randomly allocated 84 patients undergoing elective surgery aged \<=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Study Start: 2022-10-11
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Infants undergoing general anesthesia with endotracheal intubation.

Exclusion Criteria

• infants who diagnosed as cardiorespiratory problem preoperatively.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
face mask	face mask	-
high flow nasal oxygen	high flow nasal oxygen	-

Primary Outcome Measures

Name	Time	Method
Occurrence of oxygen desaturation <95%	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

Secondary Outcome Measures

Name	Time	Method
Occurrence of rescue bag mask ventilation	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
the changes in oxygen reserve index	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Number of intubation attempts	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Occurrence of oxygen desaturation <90%	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
the lowest oxygen saturation	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
ETCO2 in first breath after intubation	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
ETO2 in first breath after intubation	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Intubation times	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.	time required to securing the airway.
Occurrence of gastric insufflation	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of