Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2020-04-16
2021-02-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Apnea with high-flow nasal cannula
Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min
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.
Apnea
Apnea without any application of oxygenation
Interventions
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Apnea with high-flow nasal cannula
Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min
Apnea
Apnea without any application of oxygenation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
10 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin-Tae Kim
Professor
Principal Investigators
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Jin-Tae Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1910-091-1071
Identifier Type: -
Identifier Source: org_study_id
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