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Completed

NCT Number: NCT05578131

High-flow Nasal Cannula for Pediatric Anesthetic Induction

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.

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Key information

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants undergoing general anesthesia with endotracheal intubation.

Exclusion criteria

  • infants who diagnosed as cardiorespiratory problem preoperatively.

Treatment and study plan

high flow nasal oxygen

Procedure

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.

face mask

Procedure

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.

Primary outcomes

  1. Occurrence of oxygen desaturation <95%

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

Secondary outcomes

  1. Occurrence of oxygen desaturation <90%

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

  2. the lowest oxygen saturation

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

  3. the changes in oxygen reserve index

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

  4. ETCO2 in first breath after intubation

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

  5. ETO2 in first breath after intubation

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

  6. Number of intubation attempts

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

  7. Intubation times

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

    time required to securing the airway.

  8. Occurrence of rescue bag mask ventilation

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

  9. Occurrence of gastric insufflation

    Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2022
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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