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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05578131
Other study ID # 2209-089-1359
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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