Providing Oxygen During Intubation in the NICU Trial

Tracheal Intubation Morbidity Clinical Trial

— POINT  

Official title:

Apneic Oxygenation to Prevent Oxygen Desaturation During Intubation in the NICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451953
• Other study ID #: 19-017190
• Secondary ID: R21HD103927
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Heidi Herrick, MD, MSCE
• Phone: 267-408-6146
• Email: herrickh[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 365 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Respiratory Failure
• Respiratory Insufficiency
• Tracheal Intubation Morbidity

Intervention

Procedure:
• Apneic Oxygenation
Nasal cannula at a rate of 6L/min with 100% FiO2 during laryngoscopy and intubation attempt(s)
• Standard of Care
No respiratory support during laryngoscopy and intubation attempt(s) (current standard of care)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (35)

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Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11. — View 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. — View Citation

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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. — 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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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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. — View 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. — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcome: Cardiopulmonary resuscitation	Chest compressions with or without epinephrine	During or within 1 hour of procedure
Other	Safety Outcome: Air Leaks	New pneumothorax	Within 24 hours of procedure
Other	Safety Outcome: Nasal Trauma	New nasal trauma	Within 24 hours of procedure
Other	Safety Outcome: adverse Tracheal Intubation Adverse Events	Tracheal Intubation Adverse Events, per NEAR4NEOS definitions	During Intubation Procedure
Other	Safety Outcome: Duration of time with 100% SpO2	Duration of time with SpO2=100%	During Intubation Procedure
Primary	Primary Clinical Outcome: Change in Oxygen Saturation (SpO2)	Difference between highest SpO2 immediately prior to first intubation attempt and lowest SpO2 during the intubation encounter.	During intubation procedure
Secondary	Secondary Clinical Outcome: Severe oxygen desaturation	=20% decline in SpO2	During intubation procedure
Secondary	Secondary Clinical Outcome: SpO2<80%	SpO2<80% at any point	During intubation procedure
Secondary	Secondary Clinical Outcome: Time to SpO2 <80%	Time to SpO2 <80% from facemask removal	During intubation procedure
Secondary	Secondary Clinical Outcome: intubation success	First intubation attempt success	During intubation procedure
Secondary	Secondary Clinical Outcome: Number of intubation attempts	Total number of intubation attempts	During intubation procedure
Secondary	Secondary Clinical Outcome: Duration of intubation attempts	Duration of each intubation attempt	During intubation procedure
Secondary	Secondary Clinical Outcome: Change in pulse rate	Difference between highest and lowest pulse rate	During intubation procedure
Secondary	Secondary Clinical Outcome: pH	First blood gas pH	Three hours after intubation
Secondary	Secondary Clinical Outcome: pCO2	First blood gas pCO2	Three hours after intubation
Secondary	Secondary Clinical Outcome: PaO2	First blood gas PaO2 (for infants with indwelling arterial lines)	Three hours after intubation
Secondary	Feasibility Outcome: AO fidelity	Proportion subjects allocated to AO successfully provided the AO intervention	During the intubation procedure
Secondary	Feasibility Outcome: Protocol deviations	Number of protocol deviations and violations	During intubation procedure
Secondary	Feasibility Outcome: Screening	Proportion of intubated infants successfully screened in advance	Through study completion, an average of 18 months.
Secondary	Feasibility Outcome: Recruitment	Rates of informed consent	Through study completion, an average of 18 months.
Secondary	Feasibility Outcome: Randomization	Proportion of consented infants who were randomized	Through study completion, an average of 18 months.