High Flow Nasal Cannula for Safe Apnea

NCT04849520 | Completed FDA Device

• 1 other identifier: 2102-149-1200
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.

Conditions

Anesthesia, General; Apnea

Keywords

Oxygenation; High-flow nasal cannula

Outcome Measures

Primary Outcomes (1)

• Apnea success rate

  Proportion of patients that succeed in prolongation of apnea time while maintaining pulse oximetry \> 92%

  From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds

Secondary Outcomes (10)

• Apnea time

  From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds

• End-tidal carbon dioxide

  After resuming of bag-mask ventilation, up to 30 seconds

• Minimal pulse oximetry

  After resuming of bag-mask ventilation, up to 60 seconds

• Time to pulse oximetry of 100 percent

  After resuming of bag-mask ventilation, up to 300 seconds

• Electrocardiogram

  From start of study to end of study, up to 20 min

Study Arms (2)

High flow

EXPERIMENTAL

Application of high flow nasal cannula during apnea

Device: High flow nasal cannula

Buccal

ACTIVE COMPARATOR

Application of buccal oxygenation during apnea

Device: Buccal oxygenation

Interventions

High flow nasal cannula DEVICE

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

High flow

Buccal oxygenation DEVICE

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

Buccal

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Evidence-Based Healthcare Collaborating Agency: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (14)

• 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.

  PMID: 26705976 BACKGROUND

• 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.

  PMID: 8827740 BACKGROUND

• 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.

  PMID: 12412683 BACKGROUND

• 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.

  PMID: 15449573 BACKGROUND

• 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.

  PMID: 19672959 BACKGROUND

• 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.

  PMID: 12780980 BACKGROUND

• 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.

  PMID: 9356095 BACKGROUND

• 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.

  PMID: 28035669 BACKGROUND

• 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.

  PMID: 29330853 BACKGROUND

• 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.

  PMID: 28100527 BACKGROUND

• 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.

  PMID: 30784037 BACKGROUND

• 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.

  PMID: 15871753 BACKGROUND

• 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.

  PMID: 19846404 BACKGROUND

• 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.

  PMID: 27655276 BACKGROUND

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin-Tae Kim, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: August 12, 2021
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)