Anesthesia, GeneralNCT04849520
High Flow Nasal Cannula for Safe Apnea
A study testing High flow nasal cannula and Buccal oxygenation in people with Anesthesia, General and Apnea, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Anesthesia, General, Apnea
- What is being tested?
- High flow nasal cannula and Buccal oxygenation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2021to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under 11 years old undergoing general anesthesia with American Society of Anesthesiologists Physical Status 1 or 2.
Who cannot join
- Refusal of enrollment from one or more legal guardians of the patient
- Plan of usage of supraglottic airway device as airway maintenance device
- Presence of upper respiratory tract infection of lung disease
- Premature infants younger than postconceptual age of 40 weeks
- Anticipation of difficult bag-mask ventilation due to facial anomaly or micrognathia
- Other conditions that are considered inappropriate for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.
Read the detailed description
This is a prospective randomized controlled trial comparing two oxygenation methods for prolongation of apnea time in children aged 0 to 10 years old.
This study measures time for the pulse oximetry drop from 100% to 92% after oxygenation with 100% oxygen, applying high flow nasal cannula or buccal oxygen insufflation via an oral Ring-Adair-Elwyn endotracheal tube connected to oxygen.
- Conditions
- Anesthesia, General, Apnea
- Being tested
- High flow nasal cannula, Buccal oxygenation
- Keywords
- Oxygenation, High-flow nasal cannula
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
Oxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min
Buccal oxygenationDevice
Oxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min
| Study group | Role | What they receive |
|---|---|---|
| High flow | Experimental | Application of high flow nasal cannula during apnea Receives: Device: High flow nasal cannula |
| Buccal | Active comparator | Application of buccal oxygenation during apnea Receives: Device: Buccal oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea success rate
Proportion of patients that succeed in prolongation of apnea time while maintaining pulse oximetry > 92%
Measured: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Secondary outcomes (10)
Apnea time
Time elapsed from start of apnea to resume of bag-mask ventilation
Measured: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
End-tidal carbon dioxide
End-tidal carbon dioxide partial pressure of first resumed breath after apnea
Measured: After resuming of bag-mask ventilation, up to 30 seconds
Minimal pulse oximetry
Lowest value of pulse oximetry after resume of bag-mask ventilation
Measured: After resuming of bag-mask ventilation, up to 60 seconds
Time to pulse oximetry of 100 percent
Time elapsed from resume of bag-mask ventilation to regain of 100 percent in the pulse oximetry value
Measured: After resuming of bag-mask ventilation, up to 300 seconds
Electrocardiogram
Appearance of any arrhythmia or prolonged QT interval measured throughout the study
Measured: From start of study to end of study, up to 20 min
Mean blood pressure
Mean non-invasive blood pressure measured throughout the study
Measured: From start of study to end of study, up to 20 min
Pulse oximetry
Pulse oximetry measured throughout the study
Measured: From start of study to end of study, up to 20 min
Oxygen reserve index
Oxygen reserve index measured throughout the study
Measured: From start of study to end of study, up to 20 min
Transcutaneous carbon dioxide
Transcutaneous carbon dioxide level measured throughout the study
Measured: From start of study to end of study, up to 20 min
Heart rate
Heart rate measured throughout the study
Measured: From start of study to end of study, up to 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Aug 2021
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849520
- Sponsor's protocol ID
- 2102-149-1200
- Status last verified
- Jul 2023
- First submitted
- 12 Apr 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
PubMed 26705976Frei FJ, Ummenhofer W. Difficult intubation in paediatrics. Paediatr Anaesth. 1996;6(4):251-63. doi: 10.1111/j.1460-9592.1996.tb00447.x. No abstract available.
PubMed 8827740Schibler A, Hall GL, Businger F, Reinmann B, Wildhaber JH, Cernelc M, Frey U. Measurement of lung volume and ventilation distribution with an ultrasonic flow meter in healthy infants. Eur Respir J. 2002 Oct;20(4):912-8. doi: 10.1183/09031936.02.00226002.
PubMed 12412683King W, Petrillo T, Pettignano R. Enteral nutrition and cardiovascular medications in the pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2004 Sep-Oct;28(5):334-8. doi: 10.1177/0148607104028005334.
PubMed 15449573Schibler A, Yuill M, Parsley C, Pham T, Gilshenan K, Dakin C. Regional ventilation distribution in non-sedated spontaneously breathing newborns and adults is not different. Pediatr Pulmonol. 2009 Sep;44(9):851-8. doi: 10.1002/ppul.21000.
PubMed 19672959Schibler A, Henning R. Positive end-expiratory pressure and ventilation inhomogeneity in mechanically ventilated children. Pediatr Crit Care Med. 2002 Apr;3(2):124-128. doi: 10.1097/00130478-200204000-00006.
PubMed 12780980Erb T, Marsch SC, Hampl KF, Frei FJ. Teaching the use of fiberoptic intubation for children older than two years of age. Anesth Analg. 1997 Nov;85(5):1037-41. doi: 10.1097/00000539-199711000-00013.
PubMed 9356095Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
PubMed 28035669Lodenius A, Piehl J, Ostlund A, Ullman J, Jonsson Fagerlund M. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) vs. facemask breathing pre-oxygenation for rapid sequence induction in adults: a prospective randomised non-blinded clinical trial. Anaesthesia. 2018 May;73(5):564-571. doi: 10.1111/anae.14215. Epub 2018 Jan 13.
PubMed 29330853Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401.
PubMed 28100527Lyons C, Callaghan M. Uses and mechanisms of apnoeic oxygenation: a narrative review. Anaesthesia. 2019 Apr;74(4):497-507. doi: 10.1111/anae.14565. Epub 2019 Feb 19.
PubMed 30784037Wettstein RB, Shelledy DC, Peters JI. Delivered oxygen concentrations using low-flow and high-flow nasal cannulas. Respir Care. 2005 May;50(5):604-9.
PubMed 15871753Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
PubMed 19846404Heard A, Toner AJ, Evans JR, Aranda Palacios AM, Lauer S. Apneic Oxygenation During Prolonged Laryngoscopy in Obese Patients: A Randomized, Controlled Trial of Buccal RAE Tube Oxygen Administration. Anesth Analg. 2017 Apr;124(4):1162-1167. doi: 10.1213/ANE.0000000000001564.
PubMed 27655276
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
- ClinicalTrials.gov ID
- NCT04849520
- Acronym / sponsor ID
- 2102-149-1200
- Conditions
- Anesthesia, General, Apnea
- Keywords
- Oxygenation, High-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.
Detailed description
This is a prospective randomized controlled trial comparing two oxygenation methods for prolongation of apnea time in children aged 0 to 10 years old.
This study measures time for the pulse oximetry drop from 100% to 92% after oxygenation with 100% oxygen, applying high flow nasal cannula or buccal oxygen insufflation via an oral Ring-Adair-Elwyn endotracheal tube connected to oxygen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| High flow | Experimental | Device: High flow nasal cannulaApplication of high flow nasal cannula during apnea |
| Buccal | Active comparator | Device: Buccal oxygenationApplication of buccal oxygenation during apnea |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children under 11 years old undergoing general anesthesia with American Society of Anesthesiologists Physical Status 1 or 2.
Key exclusion criteria (6 listed)
- Refusal of enrollment from one or more legal guardians of the patient
- Plan of usage of supraglottic airway device as airway maintenance device
- Presence of upper respiratory tract infection of lung disease
- Premature infants younger than postconceptual age of 40 weeks
- Anticipation of difficult bag-mask ventilation due to facial anomaly or micrognathia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannulaOxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min | Device | High flow |
| Buccal oxygenationOxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min | Device | Buccal |
Primary outcome
Apnea success rate
Time frame: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Proportion of patients that succeed in prolongation of apnea time while maintaining pulse oximetry > 92%
10 secondary outcomes
Apnea time
Time frame: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
End-tidal carbon dioxide
Time frame: After resuming of bag-mask ventilation, up to 30 seconds
Minimal pulse oximetry
Time frame: After resuming of bag-mask ventilation, up to 60 seconds
Time to pulse oximetry of 100 percent
Time frame: After resuming of bag-mask ventilation, up to 300 seconds
Electrocardiogram
Time frame: From start of study to end of study, up to 20 min
Mean blood pressure
Time frame: From start of study to end of study, up to 20 min
Pulse oximetry
Time frame: From start of study to end of study, up to 20 min
Oxygen reserve index
Time frame: From start of study to end of study, up to 20 min
Transcutaneous carbon dioxide
Time frame: From start of study to end of study, up to 20 min
Heart rate
Time frame: From start of study to end of study, up to 20 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 26705976Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
- Background: PubMed 8827740Frei FJ, Ummenhofer W. Difficult intubation in paediatrics. Paediatr Anaesth. 1996;6(4):251-63. doi: 10.1111/j.1460-9592.1996.tb00447.x. No abstract available.
- Background: PubMed 12412683Schibler A, Hall GL, Businger F, Reinmann B, Wildhaber JH, Cernelc M, Frey U. Measurement of lung volume and ventilation distribution with an ultrasonic flow meter in healthy infants. Eur Respir J. 2002 Oct;20(4):912-8. doi: 10.1183/09031936.02.00226002.
- Background: PubMed 15449573King W, Petrillo T, Pettignano R. Enteral nutrition and cardiovascular medications in the pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2004 Sep-Oct;28(5):334-8. doi: 10.1177/0148607104028005334.
- Background: PubMed 19672959Schibler A, Yuill M, Parsley C, Pham T, Gilshenan K, Dakin C. Regional ventilation distribution in non-sedated spontaneously breathing newborns and adults is not different. Pediatr Pulmonol. 2009 Sep;44(9):851-8. doi: 10.1002/ppul.21000.
- Background: PubMed 12780980Schibler A, Henning R. Positive end-expiratory pressure and ventilation inhomogeneity in mechanically ventilated children. Pediatr Crit Care Med. 2002 Apr;3(2):124-128. doi: 10.1097/00130478-200204000-00006.
- Background: PubMed 9356095Erb T, Marsch SC, Hampl KF, Frei FJ. Teaching the use of fiberoptic intubation for children older than two years of age. Anesth Analg. 1997 Nov;85(5):1037-41. doi: 10.1097/00000539-199711000-00013.
- Background: PubMed 28035669Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
- Background: PubMed 29330853Lodenius A, Piehl J, Ostlund A, Ullman J, Jonsson Fagerlund M. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) vs. facemask breathing pre-oxygenation for rapid sequence induction in adults: a prospective randomised non-blinded clinical trial. Anaesthesia. 2018 May;73(5):564-571. doi: 10.1111/anae.14215. Epub 2018 Jan 13.
- Background: PubMed 28100527Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401.
- Background: PubMed 30784037Lyons C, Callaghan M. Uses and mechanisms of apnoeic oxygenation: a narrative review. Anaesthesia. 2019 Apr;74(4):497-507. doi: 10.1111/anae.14565. Epub 2019 Feb 19.
- Background: PubMed 15871753Wettstein RB, Shelledy DC, Peters JI. Delivered oxygen concentrations using low-flow and high-flow nasal cannulas. Respir Care. 2005 May;50(5):604-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tae Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula and Buccal oxygenation in people with Anesthesia, General and Apnea, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea success rate (time frame: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849520, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.