Clinical trial NCT05451953: Providing Oxygen During Intubation in the NICU Trial
Official title: Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Respiratory Failure
Tracheal Intubation Morbidity
Keywords: Apneic Oxygenation
Tracheal Intubation
Neonate
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Children's Hospital of Philadelphia
First posted: 2022-07-11
Enrollment: 110
Sex: ALL
Minimum age (years): 0
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group open-label randomized controlled trial.
Primary purpose: PREVENTION

Brief summary: Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.


Eligibility criteria: Inclusion Criteria:

1. Infants ≥28 weeks corrected gestational age
2. Undergoing intubation in the NICU
3. Pre-medication (including paralytic) administered

Exclusion Criteria:

1. Critical Airway or Airway Anomaly
2. Unstable hemodynamics (i.e. active resuscitation)
3. Unable to achieve SpO2 ≥90% prior to intubation attempt
4. Intubation performed by Non-NICU provider (i.e. anesthesiology or ENT)
5. Unrepaired congenital diagrammatic hernia
6. Tracheal esophageal fistula within 2 weeks of repair
7. Tracheostomy
8. Previous enrollment in the trial
9. Nasal intubation
10. COVID person under investigation (PUI) or COVID positive
11. Cyanotic heart disease
12. Receiving Extracorporeal Membrane Oxygenation support
13. Conjoined twins

Primary outcomes:
measure: Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)
timeFrame: During intubation procedure
Secondary outcomes:
measure: Secondary Clinical Outcome: Severe oxygen desaturation
timeFrame: During intubation procedure
measure: Secondary Clinical Outcome: SpO2<80%
timeFrame: During intubation procedure
measure: Secondary Clinical Outcome: Time to SpO2 <80%
timeFrame: During intubation procedure
measure: Secondary Clinical Outcome: intubation success
timeFrame: During intubation procedure
measure: Secondary Clinical Outcome: Number of intubation attempts
timeFrame: During intubation procedure
measure: Secondary Clinical Outcome: Duration of intubation attempts
timeFrame: During intubation procedure
measure: Secondary Clinical Outcome: Change in pulse rate
timeFrame: During intubation procedure
measure: Secondary Clinical Outcome: pH
timeFrame: Three hours after intubation
measure: Secondary Clinical Outcome: pCO2
timeFrame: Three hours after intubation
measure: Secondary Clinical Outcome: PaO2
timeFrame: Three hours after intubation
measure: Feasibility Outcome: AO fidelity
timeFrame: During the intubation procedure
measure: Feasibility Outcome: Protocol deviations
timeFrame: During intubation procedure
measure: Feasibility Outcome: Screening
timeFrame: Through study completion, an average of 18 months.
measure: Feasibility Outcome: Recruitment
timeFrame: Through study completion, an average of 18 months.
measure: Feasibility Outcome: Randomization
timeFrame: Through study completion, an average of 18 months.
Other outcomes:
measure: Safety Outcome: Cardiopulmonary resuscitation
timeFrame: During or within 1 hour of procedure
measure: Safety Outcome: Air Leaks
timeFrame: Within 24 hours of procedure
measure: Safety Outcome: Nasal Trauma
timeFrame: Within 24 hours of procedure
measure: Safety Outcome: adverse Tracheal Intubation Adverse Events
timeFrame: During Intubation Procedure
measure: Safety Outcome: Duration of time with 100% SpO2
timeFrame: During Intubation Procedure
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Elizabeth Foglia, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Fiore JM, Poets CF, Gauda E, Martin RJ, MacFarlane P. Cardiorespiratory events in preterm infants: interventions and consequences. J Perinatol. 2016 Apr;36(4):251-8. doi: 10.1038/jp.2015.165. Epub 2015 Nov 19.
citation: Drianovski P. [The problem of radiation resistance in birds]. Vet Med Nauki. 1974;11(4):91-7. No abstract available. Bulgarian.
citation: Whalley ET, Wahl M, Sampaio CA. Angiotensin-converting enzyme, bradykinin, angiotensin, and cerebral vessel reactivity. Hypertension. 1983 Nov-Dec;5(6 Pt 3):V34-7. doi: 10.1161/01.hyp.5.6_pt_3.v34.
citation: Poets CF, Roberts RS, Schmidt B, Whyte RK, Asztalos EV, Bader D, Bairam A, Moddemann D, Peliowski A, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Investigators. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants. JAMA. 2015 Aug 11;314(6):595-603. doi: 10.1001/jama.2015.8841.
citation: Kumar P, Denson SE, Mancuso TJ; Committee on Fetus and Newborn, Section on Anesthesiology and Pain Medicine. Premedication for nonemergency endotracheal intubation in the neonate. Pediatrics. 2010 Mar;125(3):608-15. doi: 10.1542/peds.2009-2863. Epub 2010 Feb 22.
citation: Grude O, Solli HJ, Andersen C, Oveland NP. Effect of nasal or nasopharyngeal apneic oxygenation on desaturation during induction of anesthesia and endotracheal intubation in the operating room: A narrative review of randomized controlled trials. J Clin Anesth. 2018 Dec;51:1-7. doi: 10.1016/j.jclinane.2018.07.002. Epub 2018 Jul 18.
citation: Steiner JW, Sessler DI, Makarova N, Mascha EJ, Olomu PN, Zhong JW, Setiawan CT, Handy AE, Kravitz BN, Szmuk P. Use of deep laryngeal oxygen insufflation during laryngoscopy in children: a randomized clinical trial. Br J Anaesth. 2016 Sep;117(3):350-7. doi: 10.1093/bja/aew186. Epub 2016 Jul 27.
citation: Windpassinger M, Plattner O, Gemeiner J, Roder G, Baumann A, Zimmerman NM, Sessler DI. Pharyngeal Oxygen Insufflation During AirTraq Laryngoscopy Slows Arterial Desaturation in Infants and Small Children. Anesth Analg. 2016 Apr;122(4):1153-7. doi: 10.1213/ANE.0000000000001189.
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.
citation: Napolitano N, Laverriere EK, Craig N, Snyder M, Thompson A, Davis D, Nett S, Branca A, Harwayne-Gidansky I, Sanders R Jr, Shults J, Nadkarni V, Nishisaki A; National Emergency Airway Registry for Children (NEAR4KIDS) and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI). Apneic Oxygenation As a Quality Improvement Intervention in an Academic PICU. Pediatr Crit Care Med. 2019 Dec;20(12):e531-e537. doi: 10.1097/PCC.0000000000002123.
citation: Long E, Cincotta DR, Grindlay J, Sabato S, Fauteux-Lamarre E, Beckerman D, Carroll T, Quinn N. A quality improvement initiative to increase the safety of pediatric emergency airway management. Paediatr Anaesth. 2017 Dec;27(12):1271-1277. doi: 10.1111/pan.13275. Epub 2017 Oct 24.
citation: Vukovic AA, Hanson HR, Murphy SL, Mercurio D, Sheedy CA, Arnold DH. Apneic oxygenation reduces hypoxemia during endotracheal intubation in the pediatric emergency department. Am J Emerg Med. 2019 Jan;37(1):27-32. doi: 10.1016/j.ajem.2018.04.039. Epub 2018 Apr 18.
citation: Nishisaki A, Turner DA, Brown CA 3rd, Walls RM, Nadkarni VM; National Emergency Airway Registry for Children (NEAR4KIDS); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. A National Emergency Airway Registry for children: landscape of tracheal intubation in 15 PICUs. Crit Care Med. 2013 Mar;41(3):874-85. doi: 10.1097/CCM.0b013e3182746736.
citation: Li S, Hsieh TC, Rehder KJ, Nett S, Kamat P, Napolitano N, Turner DA, Adu-Darko M, Jarvis JD, Krawiec C, Derbyshire AT, Meyer K, Giuliano JS Jr, Tala J, Tarquinio K, Ruppe MD, Sanders RC Jr, Pinto M, Howell JD, Parker MM, Nuthall G, Shepherd M, Emeriaud G, Nagai Y, Saito O, Lee JH, Simon DW, Orioles A, Walson K, Vanderford P, Shenoi A, Lee A, Bird GL, Miksa M, Graciano AL, Bain J, Skippen PW, Polikoff LA, Nadkarni V, Nishisaki A; for National Emergency Airway Registry for Children (NEAR4KIDS) and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Frequency of Desaturation and Association With Hemodynamic Adverse Events During Tracheal Intubations in PICUs. Pediatr Crit Care Med. 2018 Jan;19(1):e41-e50. doi: 10.1097/PCC.0000000000001384.
citation: Brown CA 3rd, Bair AE, Pallin DJ, Walls RM; NEAR III Investigators. Techniques, success, and adverse events of emergency department adult intubations. Ann Emerg Med. 2015 Apr;65(4):363-370.e1. doi: 10.1016/j.annemergmed.2014.10.036. Epub 2014 Dec 20.
citation: Neumann RP, von Ungern-Sternberg BS. The neonatal lung--physiology and ventilation. Paediatr Anaesth. 2014 Jan;24(1):10-21. doi: 10.1111/pan.12280. Epub 2013 Oct 24.
citation: Patel R, Lenczyk M, Hannallah RS, McGill WA. Age and the onset of desaturation in apnoeic children. Can J Anaesth. 1994 Sep;41(9):771-4. doi: 10.1007/BF03011582.
citation: Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3.
citation: Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708.
citation: Roberts KD, Leone TA, Edwards WH, Rich WD, Finer NN. Premedication for nonemergent neonatal intubations: a randomized, controlled trial comparing atropine and fentanyl to atropine, fentanyl, and mivacurium. Pediatrics. 2006 Oct;118(4):1583-91. doi: 10.1542/peds.2006-0590.
citation: O'Shea JE, Thio M, Kamlin CO, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial. Pediatrics. 2015 Nov;136(5):912-9. doi: 10.1542/peds.2015-1028. Epub 2015 Oct 19.
citation: Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156. doi: 10.1542/peds.2015-2156. Epub 2016 Feb 12.
citation: Oliveira J E Silva L, Cabrera D, Barrionuevo P, Johnson RL, Erwin PJ, Murad MH, Bellolio MF. Effectiveness of Apneic Oxygenation During Intubation: A Systematic Review and Meta-Analysis. Ann Emerg Med. 2017 Oct;70(4):483-494.e11. doi: 10.1016/j.annemergmed.2017.05.001. Epub 2017 Jul 14.
citation: Cummings JJ, Polin RA, COMMITTEE ON FETUS AND NEWBORN. Oxygen Targeting in Extremely Low Birth Weight Infants. Pediatrics. 2016;138(2):e20161576. Pediatrics. 2016 Dec;138(6):e20162904. doi: 10.1542/peds.2016-2904. No abstract available.
citation: Dempsey EM, Al Hazzani F, Faucher D, Barrington KJ. Facilitation of neonatal endotracheal intubation with mivacurium and fentanyl in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2006 Jul;91(4):F279-82. doi: 10.1136/adc.2005.087213. Epub 2006 Feb 7.
citation: Johnston L, Sawyer T, Nishisaki A, Whitfill T, Ades A, French H, Glass K, Dadiz R, Bruno C, Levit O, Gangadharan S, Scherzer D, Moussa A, Auerbach M; INSPIRE Research Network. Neonatal Intubation Competency Assessment Tool: Development and Validation. Acad Pediatr. 2019 Mar;19(2):157-164. doi: 10.1016/j.acap.2018.07.008. Epub 2018 Aug 11.
citation: Venkatesh V, Ponnusamy V, Anandaraj J, Chaudhary R, Malviya M, Clarke P, Arasu A, Curley A. Endotracheal intubation in a neonatal population remains associated with a high risk of adverse events. Eur J Pediatr. 2011 Feb;170(2):223-7. doi: 10.1007/s00431-010-1290-8. Epub 2010 Sep 15.
citation: Gupta S, Donn SM. Continuous positive airway pressure: Physiology and comparison of devices. Semin Fetal Neonatal Med. 2016 Jun;21(3):204-11. doi: 10.1016/j.siny.2016.02.009. Epub 2016 Mar 3.
citation: Roberts CT, Owen LS, Manley BJ, Davis PG; Australian & New Zealand Neonatal Network (ANZNN). High-flow support in very preterm infants in Australia and New Zealand. Arch Dis Child Fetal Neonatal Ed. 2016 Sep;101(5):F401-3. doi: 10.1136/archdischild-2015-309328. Epub 2015 Dec 17.
citation: Roberts CT, Owen LS, Manley BJ, Froisland DH, Donath SM, Dalziel KM, Pritchard MA, Cartwright DW, Collins CL, Malhotra A, Davis PG; HIPSTER Trial Investigators. Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants. N Engl J Med. 2016 Sep 22;375(12):1142-51. doi: 10.1056/NEJMoa1603694.
citation: Yoder BA, Stoddard RA, Li M, King J, Dirnberger DR, Abbasi S. Heated, humidified high-flow nasal cannula versus nasal CPAP for respiratory support in neonates. Pediatrics. 2013 May;131(5):e1482-90. doi: 10.1542/peds.2012-2742. Epub 2013 Apr 22.
citation: Bresesti I, Zivanovic S, Ives KN, Lista G, Roehr CC. National surveys of UK and Italian neonatal units highlighted significant differences in the use of non-invasive respiratory support. Acta Paediatr. 2019 May;108(5):865-869. doi: 10.1111/apa.14611. Epub 2018 Nov 13.
citation: Wilkinson DJ, Andersen CC, Smith K, Holberton J. Pharyngeal pressure with high-flow nasal cannulae in premature infants. J Perinatol. 2008 Jan;28(1):42-7. doi: 10.1038/sj.jp.7211879. Epub 2007 Nov 8.
citation: Nielsen KR, Ellington LE, Gray AJ, Stanberry LI, Smith LS, DiBlasi RM. Effect of High-Flow Nasal Cannula on Expiratory Pressure and Ventilation in Infant, Pediatric, and Adult Models. Respir Care. 2018 Feb;63(2):147-157. doi: 10.4187/respcare.05728. Epub 2017 Oct 24.
citation: Lee JH, Turner DA, Kamat P, Nett S, Shults J, Nadkarni VM, Nishisaki A; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI); National Emergency Airway Registry for Children (NEAR4KIDS). The number of tracheal intubation attempts matters! A prospective multi-institutional pediatric observational study. BMC Pediatr. 2016 Apr 29;16:58. doi: 10.1186/s12887-016-0593-y.