High-flow Nasal Oxygenation for Open Mouth
- Conditions
- Anesthesia, GeneralApnea
- Interventions
- Device: Apnea with high-flow nasal cannulaOther: Apnea
- Registration Number
- NCT04290728
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
- Children younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High flow Apnea with high-flow nasal cannula 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. Control Apnea 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.
- Primary Outcome Measures
Name Time Method Apnea time 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 Outcome Measures
Name Time Method Pulse oximetry Procedure (From induction of anesthesia to end of anesthesia) Pulse oximetry during 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) Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea
End-tidal carbon dioxide Procedure (From induction of anesthesia to end of anesthesia) End-tidal carbon dioxide partial pressure during anesthesia
Non-invasive blood pressure Procedure (From induction of anesthesia to end of anesthesia) Non-invasive blood pressure measured from forearm or leg
Oxygen reserve index Procedure (From induction of anesthesia to end of anesthesia) Oxygen reserve index measured from finger or toe
Minimum value of pulse oximetry Procedure (From induction of anesthesia to end of anesthesia) Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea
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) First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of