High-flow Nasal Oxygenation for Open Mouth

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: Terminated

Administrative data

• NCT number: NCT04290728
• Other study ID #: 1910-091-1071
• Status: Terminated
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: February 19, 2021

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Oxygenation via high-flow nasal cannula is gaining popularity in various clinical settings. It is known to increase apnea time for apneic patients including children. However, high-flow nasal cannula is known to be ineffective when the patient's mouth is kept open.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 19, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia, General
• Apnea

Intervention

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

Other:
• Apnea
Apnea without any application of oxygenation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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. — 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. Review. — 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. — View Citation

Lodenius Å, Piehl J, Östlund 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. Review. — 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. — 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. — 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 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End-tidal carbon dioxide	End-tidal carbon dioxide partial pressure during anesthesia	Procedure (From induction of anesthesia to end of anesthesia)
Secondary	Pulse oximetry	Pulse oximetry during anesthesia	Procedure (From induction of anesthesia to end of anesthesia)
Secondary	Non-invasive blood pressure	Non-invasive blood pressure measured from forearm or leg	Procedure (From induction of anesthesia to end of anesthesia)
Secondary	Oxygen reserve index	Oxygen reserve index measured from finger or toe	Procedure (From induction of anesthesia to end of anesthesia)
Secondary	Time to 100%	Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea	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)
Secondary	Minimum value of pulse oximetry	Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea	Procedure (From induction of anesthesia to end of anesthesia)
Secondary	1st value of end-tidal carbon dioxide	First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea	At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period)