High-flow Nasal Oxygenation for Open Mouth

March 26, 2021 updated by: Jin-Tae Kim, Seoul National University Hospital

Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High flow
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.
Device: Apnea with high-flow nasal cannula
Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min
Other Names:
  • Airvo 2
ACTIVE_COMPARATOR: Control
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.
Other: Apnea
Apnea without any application of oxygenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea time
Time Frame: Elapsed time starting from discontinuation of oxygen to the time point that pulse oximetry first reaches 92% (not to exceed 520 seconds)
Time required for pulse oximetry to drop to 92% after start of apnea
Elapsed time starting from discontinuation of oxygen to the time point that pulse oximetry first reaches 92% (not to exceed 520 seconds)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End-tidal carbon dioxide
Time Frame: Procedure (From induction of anesthesia to end of anesthesia)
End-tidal carbon dioxide partial pressure during anesthesia
Procedure (From induction of anesthesia to end of anesthesia)
Pulse oximetry
Time Frame: Procedure (From induction of anesthesia to end of anesthesia)
Pulse oximetry during anesthesia
Procedure (From induction of anesthesia to end of anesthesia)
Non-invasive blood pressure
Time Frame: Procedure (From induction of anesthesia to end of anesthesia)
Non-invasive blood pressure measured from forearm or leg
Procedure (From induction of anesthesia to end of anesthesia)
Oxygen reserve index
Time Frame: Procedure (From induction of anesthesia to end of anesthesia)
Oxygen reserve index measured from finger or toe
Procedure (From induction of anesthesia to end of anesthesia)
Time to 100%
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)
Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea
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)
Minimum value of pulse oximetry
Time Frame: Procedure (From induction of anesthesia to end of anesthesia)
Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea
Procedure (From induction of anesthesia to end of anesthesia)
1st value of end-tidal carbon dioxide
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)
First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea
At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 16, 2020

Primary Completion (ACTUAL)

February 19, 2021

Study Completion (ACTUAL)

February 19, 2021

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (ACTUAL)

March 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1910-091-1071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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