Clinical Trials Directory

Trials / Completed

CompletedNCT05578131

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
Phase
N/A
Study type
Interventional
Enrollment
132 (actual)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
1 Month – 12 Months
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREhigh flow nasal oxygenIn 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 maskIn 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.

Timeline

Start date
2022-10-21
Primary completion
2025-05-02
Completion
2025-05-02
First posted
2022-10-13
Last updated
2025-06-18

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05578131. Inclusion in this directory is not an endorsement.