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High-flow Nasal Cannula for Pediatric Anesthetic Induction

The Effectiveness of Preoxygenation and Apneic Oxygenation Using High-flow Nasal Cannula for Pediatric Anesthetic Induction: a Prospective Randomized Open-label Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05578131
Enrollment
132
Registered
2022-10-13
Start date
2022-10-21
Completion date
2025-05-02
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen Deficiency

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 132 patients undergoing elective surgery aged \<=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.

Interventions

In the intervention group, pre-oxygenation was provided using HFNO via Optiflow THRIVE™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) until SpO2 on pulse oximetry was \> 95% and for at least 3 min. A flow of 0.5 l/kg/min-1 was used until induction agents had been administered, and then increased to 2 l/kg/min-1. Nasal oxygenation was continued without ventilation of the lungs while waiting for neuromuscular blockade, and during placing, replacing or repositioning the airway. Anaesthetists were free to carry out bag-mask ventilation of the lungs if they considered this necessary to maintain safe oxygen saturations. After securing the airway, the patient was connected to a circle circuit primed with 100% oxygen and the FIO2 was continued at 100% for a period of at least five more minutes. Relevant times were recorded, including start of pre-oxygenation and start of induction of anaesthesia.

PROCEDUREface mask

In the control group, pre-oxygenation was provided using 100% oxygen via a sealed facemask and a circle-absorber anaesthetic circuit primed with 100% oxygen by installing a ventilation bag to the mouthpiece filter and ventilating the circuit with 100% oxygen. Anaesthetists were free to carry out bag-mask ventilation of the lungs once induction medications had been administered.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

* Infants undergoing general anesthesia with endotracheal intubation.

Exclusion criteria

* infants who diagnosed as cardiorespiratory problem preoperatively.

Design outcomes

Primary

MeasureTime frame
Occurrence of oxygen desaturation <95%from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

Secondary

MeasureTime frameDescription
the lowest oxygen saturationfrom induction of anesthesia to 1 minutes after intubation, about 10 minutes.
the changes in oxygen reserve indexfrom induction of anesthesia to 1 minutes after intubation, about 10 minutes.
ETCO2 in first breath after intubationfrom induction of anesthesia to 1 minutes after intubation, about 10 minutes.
ETO2 in first breath after intubationfrom 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.
Intubation timesfrom induction of anesthesia to 1 minutes after intubation, about 10 minutes.time required to securing the airway.
Occurrence of rescue bag mask ventilationfrom induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Occurrence of gastric insufflationfrom induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Number of intubation attemptsfrom induction of anesthesia to 1 minutes after intubation, about 10 minutes.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026