High Flow Nasal Cannula for Safe Apnea

NCT ID: NCT04849520

Last Updated: 2023-07-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2023-03-21

Brief Summary

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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

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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

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Anesthesia, General Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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High flow

Application of high flow nasal cannula during apnea

Group Type EXPERIMENTAL

High flow nasal cannula

Intervention Type DEVICE

Oxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min

Buccal

Application of buccal oxygenation during apnea

Group Type ACTIVE_COMPARATOR

Buccal oxygenation

Intervention Type DEVICE

Oxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min

Interventions

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High flow nasal cannula

Oxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min

Intervention Type DEVICE

Buccal oxygenation

Oxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children under 11 years old undergoing general anesthesia with American Society of Anesthesiologists Physical Status 1 or 2.

Exclusion Criteria

* 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
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Evidence-Based Healthcare Collaborating Agency

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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South Korea

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.

Reference Type BACKGROUND
PMID: 26705976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8827740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12412683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15449573 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19672959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12780980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9356095 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28035669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29330853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28100527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30784037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15871753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19846404 (View on PubMed)

Heard 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.

Reference Type BACKGROUND
PMID: 27655276 (View on PubMed)

Other Identifiers

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2102-149-1200

Identifier Type: -

Identifier Source: org_study_id

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