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High-flow Nasal Oxygenation for Open Mouth

Primary Purpose

Anesthesia, General, Apnea

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Apnea with high-flow nasal cannula
Apnea
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia, General focused on measuring High-flow nasal cannula, Preoxygenation, Apnea time, General anesthesia

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2.

Exclusion Criteria:

  • Refusal to enrollment from one or more of legal guardians of the patient
  • Children who are planned to use supraglottic airway device
  • Children with upper respiratory tract infection or pulmonary interstitial disease
  • Preterm babies under 40 weeks of postconceptual age
  • Children who are expected to have difficult airway for bag-mask ventilation

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flow

Control

Arm Description

Apply high-flow nasal oxygenation during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired.

Apply nothing during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired.

Outcomes

Primary Outcome Measures

Apnea time
Time required for pulse oximetry to drop to 92% after start of apnea

Secondary Outcome Measures

End-tidal carbon dioxide
End-tidal carbon dioxide partial pressure during anesthesia
Pulse oximetry
Pulse oximetry during anesthesia
Non-invasive blood pressure
Non-invasive blood pressure measured from forearm or leg
Oxygen reserve index
Oxygen reserve index measured from finger or toe
Time to 100%
Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea
Minimum value of pulse oximetry
Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea
1st value of end-tidal carbon dioxide
First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea

Full Information

First Posted
February 24, 2020
Last Updated
March 26, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04290728
Brief Title
High-flow Nasal Oxygenation for Open Mouth
Official Title
Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Change in the study plan
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the effect of high-flow nasal oxygenation on safe apnea time for children undergoing general anesthesia, with their mouth open.
Detailed Description
Oxygenation via high-flow nasal cannula is gaining popularity in various clinical settings. It is known to increase apnea time for apneic patients including children. However, high-flow nasal cannula is known to be ineffective when the patient's mouth is kept open. When trying to intubate the patient during induction of anesthesia, the patient should be apneic with administration of neuromuscular blocking agent, and the mouth should be open for introduction of laryngoscope. We designed a prospective randomized controlled study to evaluate the effect of high-flow nasal oxygenation in the aforementioned setting for trying to intubate the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, General, Apnea
Keywords
High-flow nasal cannula, Preoxygenation, Apnea time, General anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High flow
Arm Type
Experimental
Arm Description
Apply high-flow nasal oxygenation during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Apply nothing during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired.
Intervention Type
Device
Intervention Name(s)
Apnea with high-flow nasal cannula
Other Intervention Name(s)
Airvo 2
Intervention Description
Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min
Intervention Type
Other
Intervention Name(s)
Apnea
Intervention Description
Apnea without any application of oxygenation
Primary Outcome Measure Information:
Title
Apnea time
Description
Time required for pulse oximetry to drop to 92% after start of apnea
Time Frame
Elapsed time starting from discontinuation of oxygen to the time point that pulse oximetry first reaches 92% (not to exceed 520 seconds)
Secondary Outcome Measure Information:
Title
End-tidal carbon dioxide
Description
End-tidal carbon dioxide partial pressure during anesthesia
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
Pulse oximetry
Description
Pulse oximetry during anesthesia
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
Non-invasive blood pressure
Description
Non-invasive blood pressure measured from forearm or leg
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
Oxygen reserve index
Description
Oxygen reserve index measured from finger or toe
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
Time to 100%
Description
Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea
Time Frame
Elapsed time starting from re-start of bag-mask ventilation at the end of apnea period to the time point that pulse oximetry first reaches 100% (estimated less than 2 minutes)
Title
Minimum value of pulse oximetry
Description
Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea
Time Frame
Procedure (From induction of anesthesia to end of anesthesia)
Title
1st value of end-tidal carbon dioxide
Description
First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea
Time Frame
At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2. Exclusion Criteria: Refusal to enrollment from one or more of legal guardians of the patient Children who are planned to use supraglottic airway device Children with upper respiratory tract infection or pulmonary interstitial disease Preterm babies under 40 weeks of postconceptual age Children who are expected to have difficult airway for bag-mask ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
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High-flow Nasal Oxygenation for Open Mouth

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