High-flow Nasal Oxygenation for Open Mouth

NCT04290728 | Terminated FDA Device

• 1 other identifier: 1910-091-1071
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, General; Apnea

Keywords

High-flow nasal cannula; Preoxygenation; Apnea time; General anesthesia

Outcome Measures

Primary Outcomes (1)

• Apnea time

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

  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)

• End-tidal carbon dioxide

  Procedure (From induction of anesthesia to end of anesthesia)

• Pulse oximetry

  Procedure (From induction of anesthesia to end of anesthesia)

• Non-invasive blood pressure

  Procedure (From induction of anesthesia to end of anesthesia)

• Oxygen reserve index

  Procedure (From induction of anesthesia to end of anesthesia)

• Time to 100%

  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)

Study Arms (2)

High flow

EXPERIMENTAL

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.

Device: Apnea with high-flow nasal cannula

Control

ACTIVE COMPARATOR

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.

Other: Apnea

Interventions

Apnea with high-flow nasal cannula DEVICE

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

Also known as: Airvo 2

High flow

Apnea OTHER

Apnea without any application of oxygenation

Control

Eligibility Criteria

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

You may qualify if:

• Children younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (13)

• 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

MeSH Terms

Conditions

Apnea

Interventions

N(6)-2-(4-aminophenyl)ethyladenosine

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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, controlled clinical trial

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 2, 2020
• Study Start: April 16, 2020
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)