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High-flow Nasal Cannula for Pediatric Anesthetic Induction

Primary Purpose

Oxygen Deficiency

Status

Not yet recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

high flow nasal oxygen

face mask

About this trial

This is an interventional prevention trial for Oxygen Deficiency

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Infants undergoing general anesthesia with endotracheal intubation.

Exclusion Criteria:

infants who diagnosed as cardiorespiratory problem preoperatively.

Sites / Locations

Seoul national university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high flow nasal oxygen

face mask

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of oxygen desaturation <95%

Secondary Outcome Measures

Occurrence of oxygen desaturation <90%

the lowest oxygen saturation

the changes in oxygen reserve index

ETCO2 in first breath after intubation

ETO2 in first breath after intubation

Number of intubation attempts

Intubation times

time required to securing the airway.

Occurrence of rescue bag mask ventilation

Occurrence of gastric insufflation

Full Information

NCT ID

NCT05578131

First Posted

October 10, 2022

Last Updated

October 12, 2022

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05578131

Brief Title

High-flow Nasal Cannula for Pediatric Anesthetic Induction

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 11, 2022 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oxygen Deficiency

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

high flow nasal oxygen

Arm Type

Experimental

Arm Title

face mask

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

high flow nasal oxygen

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

face mask

Intervention Description

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.

Primary Outcome Measure Information:

Title

Occurrence of oxygen desaturation <95%

Time Frame