Seoul national university hospital
Seoul, South Korea
NCT Number: NCT05578131
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.
Looking for future studies?
Notify Me1 month–12 month
All sexes
Interventional
Not applicable
Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
time required to securing the airway.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Seoul National University Hospital
Other
The Effectiveness of Preoxygenation and Apneic Oxygenation Using High-flow Nasal Cannula for Pediatric Anesthetic Induction: a Prospective Randomized Open-label Clinical Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT06256692
Accidental Injuries, Hypoxemia
Copenhagen, Region H, Denmark
View Trial DetailsNCT04266665
Brain Diseases, Brain Neoplasms
Thessaloniki, Greece
View Trial DetailsNCT06405984
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Female Urogenital Diseases and Pregnancy Complications
Norfolk, Virginia, United States
View Trial DetailsNCT04322994
Anesthesia; Adverse Effect, Desaturation of Blood
Palo Alto, California, United States
View Trial Details