Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery
NCT ID: NCT05378685
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2018-07-01
2022-06-30
Brief Summary
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Detailed Description
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This is a single-center, prospective randomized control trial of patients less than 2 weeks of age who undergo endotracheal intubation at the time of cardiac surgery. The investigators exclude patients who were \<37 weeks corrected gestational age (GA) at surgery, had orofacial or gastrointestinal anomalies, required \>5 days of intubation before surgery, or required ECMO or \>5 minutes of CPR at any time during the hospitalization. Patients are randomized to nasal (NI) or oral intubation (OI) by a trained pediatric cardiac anesthesiologist at the time of their surgery.
Infants are followed post-operatively until the time of discharge and otherwise receive routine care in the intensive care unit and acute cardiology service. Information regarding feeding milestones is obtained from the electronic medical record.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Oral
Infants in this group are endotracheally intubated through their mouth.
Endotracheal intubation
The patient is intubated using a laryngoscope and cuffed endotracheal tube. The selection and size of the equipment is at the discretion of the pediatric cardiac anesthesiologist.
Nasal
Infants in this group are endotracheally intubated through their nose.
Endotracheal intubation
The patient is intubated using a laryngoscope and cuffed endotracheal tube. The selection and size of the equipment is at the discretion of the pediatric cardiac anesthesiologist.
Interventions
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Endotracheal intubation
The patient is intubated using a laryngoscope and cuffed endotracheal tube. The selection and size of the equipment is at the discretion of the pediatric cardiac anesthesiologist.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Orofacial or gastrointestinal anomalies
* Devastating neurologic injury or malformation
* Intubation \> 5 days prior to surgery
* \> 5 minutes of CPR or ECMO at any time
2 Weeks
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Melissa Yildirim, MD
Resident, Pediatrics
Principal Investigators
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Melissa Yildirim, MD
Role: PRINCIPAL_INVESTIGATOR
UVA Pediatric Intensive Care Unit
Locations
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University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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References
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Averin K, Uzark K, Beekman RH 3rd, Willging JP, Pratt J, Manning PB. Postoperative assessment of laryngopharyngeal dysfunction in neonates after Norwood operation. Ann Thorac Surg. 2012 Oct;94(4):1257-61. doi: 10.1016/j.athoracsur.2012.01.009. Epub 2012 Mar 14.
Hehir DA, Easley RB, Byrnes J. Noncardiac Challenges in the Cardiac ICU: Feeding, Growth and Gastrointestinal Complications, Anticoagulation, and Analgesia. World J Pediatr Congenit Heart Surg. 2016 Mar;7(2):199-209. doi: 10.1177/2150135115615847.
Kogon BE, Ramaswamy V, Todd K, Plattner C, Kirshbom PM, Kanter KR, Simsic J. Feeding difficulty in newborns following congenital heart surgery. Congenit Heart Dis. 2007 Sep-Oct;2(5):332-7. doi: 10.1111/j.1747-0803.2007.00121.x.
Piggott KD, Babb J, Yong S, Fakioglu H, Blanco C, DeCampli W, Pourmoghadam K. Risk Factors for Gastrostomy Tube Placement in Single Ventricle Patients Following The Norwood Procedure. Semin Thorac Cardiovasc Surg. 2018 Winter;30(4):443-447. doi: 10.1053/j.semtcvs.2018.02.012. Epub 2018 Feb 9.
Pinelli J, Symington A. Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD001071. doi: 10.1002/14651858.CD001071.pub2.
Scahill CJ, Graham EM, Atz AM, Bradley SM, Kavarana MN, Zyblewski SC. Preoperative Feeding Neonates With Cardiac Disease. World J Pediatr Congenit Heart Surg. 2017 Jan;8(1):62-68. doi: 10.1177/2150135116668833.
Skinner ML, Halstead LA, Rubinstein CS, Atz AM, Andrews D, Bradley SM. Laryngopharyngeal dysfunction after the Norwood procedure. J Thorac Cardiovasc Surg. 2005 Nov;130(5):1293-301. doi: 10.1016/j.jtcvs.2005.07.013. Epub 2005 Oct 13.
Spence K, Barr P. Nasal versus oral intubation for mechanical ventilation of newborn infants. Cochrane Database Syst Rev. 2000;1999(2):CD000948. doi: 10.1002/14651858.CD000948.
Xue FS, Liao X, Liu KP, Liu Y, Xu YC, Yang QY, Li P, Li CW, Sun HT. The circulatory responses to tracheal intubation in children: a comparison of the oral and nasal routes. Anaesthesia. 2007 Mar;62(3):220-6. doi: 10.1111/j.1365-2044.2007.04939.x.
Yildirim MI, Spaeder MC, Castro BA, Chamberlain R, Fuzy L, Howard S, McNaull P, Raphael J, Sharma R, Vizzini S, Wielar A, Frank DU. The Impact of Nasal Intubation on Feeding Outcomes in Neonates Requiring Cardiac Surgery: A Randomized Control Trial. Pediatr Cardiol. 2024 Feb;45(2):426-432. doi: 10.1007/s00246-023-03322-7. Epub 2023 Oct 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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20789
Identifier Type: -
Identifier Source: org_study_id
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