High-flow Nasal Cannula for Pediatric Anesthetic Induction

Oxygen Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05578131
• Other study ID #: 2209-089-1359
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: Eun-hee Kim
• Phone: +82-2-2072-3664
• Email: beloveun[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 84 patients undergoing elective surgery aged <=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

Inclusion Criteria:

• Infants undergoing general anesthesia with endotracheal intubation.

Exclusion Criteria:

• infants who diagnosed as cardiorespiratory problem preoperatively.

Related Conditions & MeSH terms

• Hypoxia
• Oxygen Deficiency

Intervention

Procedure:
• high flow nasal oxygen
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
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of oxygen desaturation <95%		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	Occurrence of oxygen desaturation <90%		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	the lowest oxygen saturation		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	the changes in oxygen reserve index		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	ETCO2 in first breath after intubation		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	ETO2 in first breath after intubation		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	Number of intubation attempts		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	Intubation times	time required to securing the airway.	from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	Occurrence of rescue bag mask ventilation		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary	Occurrence of gastric insufflation		from induction of anesthesia to 1 minutes after intubation, about 10 minutes.