High-flow Nasal Cannula for Pediatric Anesthetic Induction

NCT05578131 | Completed

• 1 other identifier: 2209-089-1359
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Deficiency

Outcome Measures

Primary Outcomes (1)

• Occurrence of oxygen desaturation <95%

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

Secondary Outcomes (9)

• 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.

• the changes in oxygen reserve index

  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.

Study Arms (2)

high flow nasal oxygen

EXPERIMENTAL

Procedure: high flow nasal oxygen

face mask

ACTIVE COMPARATOR

Procedure: face mask

Interventions

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.

high flow nasal oxygen

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.

face mask

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants undergoing general anesthesia with endotracheal intubation.

You may not qualify if:

• infants who diagnosed as cardiorespiratory problem preoperatively.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Masks

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Eun-hee Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: October 21, 2022
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

KR (1)