Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery

NCT05378685 | Unknown

• 1 other identifier: 20789
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Often, infants struggle to feed orally after surgery for congenital heart disease and may require supplemental feeding interventions at discharge. In this study, the investigators prospectively randomize infants to oral or nasal endotracheal intubation for surgery and assess postoperative feeding success.

Conditions

Congenital Heart Disease; Oral Aversion

Outcome Measures

Primary Outcomes (1)

• Feeding method at discharge

  Infants are discharged home either fed completely by mouth, fed by nasogastric tube (plus/minus some oral feeds), or gastrostomy tube (plus/minus some oral feeds).

  Approximately 1 month after surgery

Secondary Outcomes (1)

• Time to full feeds

  Approximately 1 month after surgery

Study Arms (2)

Oral

ACTIVE COMPARATOR

Infants in this group are endotracheally intubated through their mouth.

Procedure: Endotracheal intubation

Nasal

ACTIVE COMPARATOR

Infants in this group are endotracheally intubated through their nose.

Procedure: Endotracheal intubation

Interventions

Endotracheal intubation PROCEDURE

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; Oral

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants who require surgery for congenital heart disease before 2 weeks of age

You may not qualify if:

• \< 37 weeks estimated gestational age at the time of surgery
• Orofacial or gastrointestinal anomalies
• Devastating neurologic injury or malformation
• Intubation \> 5 days prior to surgery
• \> 5 minutes of CPR or ECMO at any time

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Related Publications (10)

• 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.

  PMID: 22421593 BACKGROUND

• 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.

  PMID: 26957404 BACKGROUND

• 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.

  PMID: 18377449 BACKGROUND

• 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.

  PMID: 29432890 BACKGROUND

• 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.

  PMID: 16235279 BACKGROUND

• 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.

  PMID: 28033074 BACKGROUND

• 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.

  PMID: 16256781 BACKGROUND

• 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.

  PMID: 10796391 BACKGROUND

• 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.

  PMID: 17300297 BACKGROUND

• 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.

  PMID: 37853163 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Melissa Yildirim, MD

  UVA Pediatric Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The intubation route (oral or nasal) is obvious and visible to everyone who interacts with the infant postoperatively.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Pediatrics

Model Details: Using a random number generator, infants are randomized to oral or nasal intubation by a pediatric cardiac anesthesiologist at the time of surgery. The anesthesiologist may elect to diverge from the randomization based on their clinical judgement and patient safety. Infants are analyzed as treated.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 18, 2022
• Study Start: July 1, 2018
• Primary Completion: December 20, 2021
• Study Completion: June 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)