High Flow Nasal Cannula for Safe Apnea

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849520
• Other study ID #: 2102-149-1200
• Status: Completed
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: March 21, 2023

Study information

• Verified date: July 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Apnea

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Evidence-Based Healthcare Collaborating Agency

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Apnea time	Time elapsed from start of apnea to resume of bag-mask ventilation	From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Secondary	End-tidal carbon dioxide	End-tidal carbon dioxide partial pressure of first resumed breath after apnea	After resuming of bag-mask ventilation, up to 30 seconds
Secondary	Minimal pulse oximetry	Lowest value of pulse oximetry after resume of bag-mask ventilation	After resuming of bag-mask ventilation, up to 60 seconds
Secondary	Time to pulse oximetry of 100 percent	Time elapsed from resume of bag-mask ventilation to regain of 100 percent in the pulse oximetry value	After resuming of bag-mask ventilation, up to 300 seconds
Secondary	Electrocardiogram	Appearance of any arrhythmia or prolonged QT interval measured throughout the study	From start of study to end of study, up to 20 min
Secondary	Mean blood pressure	Mean non-invasive blood pressure measured throughout the study	From start of study to end of study, up to 20 min
Secondary	Pulse oximetry	Pulse oximetry measured throughout the study	From start of study to end of study, up to 20 min
Secondary	Oxygen reserve index	Oxygen reserve index measured throughout the study	From start of study to end of study, up to 20 min
Secondary	Transcutaneous carbon dioxide	Transcutaneous carbon dioxide level measured throughout the study	From start of study to end of study, up to 20 min
Secondary	Heart rate	Heart rate measured throughout the study	From start of study to end of study, up to 20 min