Skip to content

High-flow Nasal Oxygenation for Open Mouth

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04290728
Enrollment
15
Registered
2020-03-02
Start date
2020-04-16
Completion date
2021-02-19
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General, Apnea

Keywords

High-flow nasal cannula, Preoxygenation, Apnea time, General anesthesia

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.

Interventions

DEVICEApnea with high-flow nasal cannula

Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min

OTHERApnea

Apnea without any application of oxygenation

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomized, controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
No minimum to 10 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Apnea timeElapsed 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

MeasureTime frameDescription
End-tidal carbon dioxideProcedure (From induction of anesthesia to end of anesthesia)End-tidal carbon dioxide partial pressure during anesthesia
Pulse oximetryProcedure (From induction of anesthesia to end of anesthesia)Pulse oximetry during anesthesia
Non-invasive blood pressureProcedure (From induction of anesthesia to end of anesthesia)Non-invasive blood pressure measured from forearm or leg
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
Minimum value of pulse oximetryProcedure (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 dioxideAt 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
Oxygen reserve indexProcedure (From induction of anesthesia to end of anesthesia)Oxygen reserve index measured from finger or toe

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026