Clinical trial NCT04290728: 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
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia, General
Apnea
Keywords: High-flow nasal cannula
Preoxygenation
Apnea time
General anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 15
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled clinical trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Apnea time
timeFrame: Elapsed time starting from discontinuation of oxygen to the time point that pulse oximetry first reaches 92% (not to exceed 520 seconds)
Secondary outcomes:
measure: End-tidal carbon dioxide
timeFrame: Procedure (From induction of anesthesia to end of anesthesia)
measure: Pulse oximetry
timeFrame: Procedure (From induction of anesthesia to end of anesthesia)
measure: Non-invasive blood pressure
timeFrame: Procedure (From induction of anesthesia to end of anesthesia)
measure: Oxygen reserve index
timeFrame: Procedure (From induction of anesthesia to end of anesthesia)
measure: Time to 100%
timeFrame: 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)
measure: Minimum value of pulse oximetry
timeFrame: Procedure (From induction of anesthesia to end of anesthesia)
measure: 1st value of end-tidal carbon dioxide
timeFrame: At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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