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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apnea with high-flow nasal cannula | Device | Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| End-tidal carbon dioxide | End-tidal carbon dioxide partial pressure during anesthesia | Procedure (From induction of anesthesia to end of anesthesia) |
| Pulse oximetry | Pulse oximetry during anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26705976 | Background | 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. | |
| 8827740 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 13, 2022 | |
| Reset | Feb 10, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 13, 2022 | Feb 10, 2023 |
| ID | Term |
|---|---|
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C086112 | N(6)-2-(4-aminophenyl)ethyladenosine |
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Randomized, controlled clinical trial
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| Apnea | Other | Apnea without any application of oxygenation |
|
| Procedure (From induction of anesthesia to end of anesthesia) |
| Non-invasive blood pressure | Non-invasive blood pressure measured from forearm or leg | Procedure (From induction of anesthesia to end of anesthesia) |
| Oxygen reserve index | Oxygen reserve index measured from finger or toe | Procedure (From induction of anesthesia to end of anesthesia) |
| 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) |
| 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) |
| 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) |
| 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. |
| 12412683 | 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. |
| 15449573 | 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. |
| 19672959 | 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. |
| 12780980 | 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. |
| 9356095 | 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. |
| 28035669 | 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. |
| 29330853 | 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. |
| 28100527 | 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. |
| 30784037 | 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. |
| 15871753 | 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. |
| 19846404 | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |