AzTrials
AzTrials

Anesthesia, GeneralNCT04290728

High-flow Nasal Oxygenation for Open Mouth

A study testing Apnea with high-flow nasal cannula and Apnea in people with Anesthesia, General and Apnea, run by Seoul National University Hospital at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. 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?
Apnea with high-flow nasal cannula and Apnea
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSouth Korea
Study dates
16 Apr 2020to 19 Feb 2021
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 younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Apnea with high-flow nasal cannula, Apnea
Keywords
High-flow nasal cannula, Preoxygenation, Apnea time, General anesthesia
Medical subject headings
Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apnea with high-flow nasal cannulaDevice

    Also called Airvo 2

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

  • ApneaOther

    Apnea without any application of oxygenation

Study groups in NCT04290728
Study groupRoleWhat they receive
High flowExperimentalApply 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.
Receives: Device: Apnea with high-flow nasal cannula
ControlActive comparatorApply 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.
Receives: Other: Apnea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apnea time

    Time required for pulse oximetry to drop to 92% after start of apnea

    Measured: Elapsed time starting from discontinuation of oxygen to the time point that pulse oximetry first reaches 92% (not to exceed 520 seconds)

Secondary outcomes (7)

  1. End-tidal carbon dioxide

    End-tidal carbon dioxide partial pressure during anesthesia

    Measured: Procedure (From induction of anesthesia to end of anesthesia)

  2. Pulse oximetry

    Pulse oximetry during anesthesia

    Measured: Procedure (From induction of anesthesia to end of anesthesia)

  3. Non-invasive blood pressure

    Non-invasive blood pressure measured from forearm or leg

    Measured: Procedure (From induction of anesthesia to end of anesthesia)

  4. Oxygen reserve index

    Oxygen reserve index measured from finger or toe

    Measured: Procedure (From induction of anesthesia to end of anesthesia)

  5. Time to 100%

    Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea

    Measured: 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)

  6. Minimum value of pulse oximetry

    Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea

    Measured: Procedure (From induction of anesthesia to end of anesthesia)

  7. 1st value of end-tidal carbon dioxide

    First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea

    Measured: At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start16 Apr 2020
  3. Primary completion19 Feb 2021
  4. Study completion19 Feb 2021

Why it stopped: Change in the study plan

Resources

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
Randomized, controlled clinical trial
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290728
Sponsor's protocol ID
1910-091-1071
Status last verified
Mar 2021
First submitted
24 Feb 2020
Last updated
1 Apr 2021
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 26705976

  • Frei 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 8827740

  • Schibler 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 12412683

  • King 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 15449573

  • Schibler 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 19672959

  • Schibler 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 12780980

  • Erb 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 9356095

  • Mir 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 28035669

  • Lodenius 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 29330853

  • Humphreys 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 28100527

  • Lyons 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 30784037

  • Wettstein 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 15871753

  • Parke 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 19846404

Questions about this trial

What is this clinical trial studying?

A study testing Apnea with high-flow nasal cannula and Apnea 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 5 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: stopped early, as of the sponsor's last update on 1 Apr 2021. 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 was stopped early (reason given: Change in the study plan). Results are not available in the source record.

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 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)). 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 NCT04290728, which also lists 13 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 1 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in