Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Apnea time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Apnea with high-flow nasal cannula (Device)
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.
Intervention: Apnea (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Pulse oximetry(Procedure (From induction of anesthesia to end of anesthesia))
- Time to 100%(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))
- End-tidal carbon dioxide(Procedure (From induction of anesthesia to end of anesthesia))
- Non-invasive blood pressure(Procedure (From induction of anesthesia to end of anesthesia))
- Oxygen reserve index(Procedure (From induction of anesthesia to end of anesthesia))
- Minimum value of pulse oximetry(Procedure (From induction of anesthesia to end of anesthesia))
- 1st value of end-tidal carbon dioxide(At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period))
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital