Nasotracheal Intubation With VL vs DL in Infants Trial

NCT05433155 | Completed

• 1 other identifier: 22-019921
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 8

Brief Summary

Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.

Conditions

Intubation Complication; Intubation; Difficult or Failed; Hypoxia; Hypoxemia; Anesthesia Intubation Complication; Pediatric HD

Keywords

Laryngoscope; Video Laryngoscope; Direct Laryngoscope; Nasotracheal Intubation; First attempt success; Intubation complications; Intubation technical difficulties; Randomization; Multi-center

Outcome Measures

Primary Outcomes (1)

• VL first attempt success rate

  Direct observation of intubation in the OR and medical record review

  24 hours

Secondary Outcomes (7)

• Number of attempts for successful intubation

  24 hours

• Incidence of failed NTI (conversion to oral intubation)

  24 hours

• Incidence of failure to intubate with assigned device

  24 hours

• Incidence of complications over all attempts including non-severe and severe complications

  24 hours

• Incidence of 1st-attempt complications

  24 hours

Study Arms (2)

Videolaryngoscopy

ACTIVE COMPARATOR

Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope

Device: Nasotracheal intubation

Direct Laryngoscopy

ACTIVE COMPARATOR

Nasotracheal Intubation performed with the standard clinical direct blades

Device: Nasotracheal intubation

Interventions

Nasotracheal intubation DEVICE

Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy

Direct Laryngoscopy; Videolaryngoscopy

Eligibility Criteria

• Age: 1 Day - 365 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females age 0 -365 days
• Scheduled for elective cardiothoracic surgery or cardiac catheterization procedures lasting longer than 30 minutes under general anesthesia where nasotracheal intubation will be performed by an anesthesiology clinician
• Plan to use a neuromuscular blocking drug prior to intubation as standard of care
• Parental/guardian permission (informed consent)
• For clinician participants:
• \- Anesthesia attending, anesthesia fellows, anesthesia resident, Anesthesia Assistant (AA) or CRNA

You may not qualify if:

• Less than 36 weeks gestation
• Less than 2 kg
• History of difficult intubation
• History of abnormal airway
• Predictive of difficult intubation upon physical examination
• Preoperative endotracheal tube or tracheostomy
• Emergency cases

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Children's Hospital Colorado: collaborator
• Seattle Children's Hospital: collaborator
• Baylor College of Medicine: collaborator
• Children's Medical Center Dallas: collaborator
• Dell Children's Medical Center of Central Texas: collaborator
• Children's National Research Institute: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (8)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203-6869, United States

Location

University of Texas at Austin Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (19)

• 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.

  PMID: 26705976 BACKGROUND

• Garcia-Marcinkiewicz AG, Kovatsis PG, Hunyady AI, Olomu PN, Zhang B, Sathyamoorthy M, Gonzalez A, Kanmanthreddy S, Galvez JA, Franz AM, Peyton J, Park R, Kiss EE, Sommerfield D, Griffis H, Nishisaki A, von Ungern-Sternberg BS, Nadkarni VM, McGowan FX Jr, Fiadjoe JE; PeDI Collaborative investigators. First-attempt success rate of video laryngoscopy in small infants (VISI): a multicentre, randomised controlled trial. Lancet. 2020 Dec 12;396(10266):1905-1913. doi: 10.1016/S0140-6736(20)32532-0.

  PMID: 33308472 BACKGROUND

• Greene NH, Jooste EH, Thibault DP, Wallace AS, Wang A, Vener DF, Matsouaka RA, Jacobs ML, Jacobs JP, Hill KD, Ames WA. A Study of Practice Behavior for Endotracheal Intubation Site for Children With Congenital Heart Disease Undergoing Surgery: Impact of Endotracheal Intubation Site on Perioperative Outcomes-An Analysis of the Society of Thoracic Surgeons Congenital Cardiac Anesthesia Society Database. Anesth Analg. 2019 Oct;129(4):1061-1068. doi: 10.1213/ANE.0000000000003594.

  PMID: 30198928 BACKGROUND

• Jiang J, Ma DX, Li B, Wu AS, Xue FS. Videolaryngoscopy versus direct laryngoscopy for nasotracheal intubation: A systematic review and meta-analysis of randomised controlled trials. J Clin Anesth. 2019 Feb;52:6-16. doi: 10.1016/j.jclinane.2018.08.029. Epub 2018 Aug 25.

  PMID: 30153543 BACKGROUND

• 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.

  PMID: 26482669 BACKGROUND

• Low D, Healy D, Rasburn N. The use of the BERCI DCI Video Laryngoscope for teaching novices direct laryngoscopy and tracheal intubation. Anaesthesia. 2008 Feb;63(2):195-201. doi: 10.1111/j.1365-2044.2007.05323.x.

  PMID: 18211452 BACKGROUND

• Herbstreit F, Fassbender P, Haberl H, Kehren C, Peters J. Learning endotracheal intubation using a novel videolaryngoscope improves intubation skills of medical students. Anesth Analg. 2011 Sep;113(3):586-90. doi: 10.1213/ANE.0b013e3182222a66. Epub 2011 Jun 16.

  PMID: 21680859 BACKGROUND

• Sun H, Liu M, Lin Z, Jiang H, Niu Y, Wang H, Chen S. Comprehensive identification of 125 multifarious constituents in Shuang-huang-lian powder injection by HPLC-DAD-ESI-IT-TOF-MS. J Pharm Biomed Anal. 2015 Nov 10;115:86-106. doi: 10.1016/j.jpba.2015.06.013. Epub 2015 Jun 30.

  PMID: 26177215 BACKGROUND

• Lingappan K, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009975. doi: 10.1002/14651858.CD009975.pub3.

  PMID: 29862490 BACKGROUND

• Goto T, Gibo K, Hagiwara Y, Morita H, Brown DF, Brown CA 3rd, Hasegawa K; Japanese Emergency Medicine Network Investigators. Multiple failed intubation attempts are associated with decreased success rates on the first rescue intubation in the emergency department: a retrospective analysis of multicentre observational data. Scand J Trauma Resusc Emerg Med. 2015 Jan 16;23:5. doi: 10.1186/s13049-014-0085-8.

  PMID: 25700237 BACKGROUND

• Goto T, Watase H, Morita H, Nagai H, Brown CA 3rd, Brown DF, Hasegawa K; Japanese Emergency Medicine Network Investigators. Repeated attempts at tracheal intubation by a single intubator associated with decreased success rates in emergency departments: an analysis of a multicentre prospective observational study. Emerg Med J. 2015 Oct;32(10):781-6. doi: 10.1136/emermed-2013-203473. Epub 2014 Dec 31.

  PMID: 25552546 BACKGROUND

• Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.

  PMID: 23574475 BACKGROUND

• Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.

  PMID: 15271750 BACKGROUND

• Grunwell JR, Kamat PP, Miksa M, Krishna A, Walson K, Simon D, Krawiec C, Breuer R, Lee JH, Gradidge E, Tarquinio K, Shenoi A, Shults J, Nadkarni V, Nishisaki A; National Emergency Airway Registry for Children (NEAR4KIDS) and the Pediatric Acute Lung Injury and Sepsis (PALISI) Network. Trend and Outcomes of Video Laryngoscope Use Across PICUs. Pediatr Crit Care Med. 2017 Aug;18(8):741-749. doi: 10.1097/PCC.0000000000001175.

  PMID: 28492404 BACKGROUND

• Abdelgadir IS, Phillips RS, Singh D, Moncreiff MP, Lumsden JL. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in children (excluding neonates). Cochrane Database Syst Rev. 2017 May 24;5(5):CD011413. doi: 10.1002/14651858.CD011413.pub2.

  PMID: 28539007 BACKGROUND

• Galvez JA, Acquah S, Ahumada L, Cai L, Polanski M, Wu L, Simpao AF, Tan JM, Wasey J, Fiadjoe JE. Hypoxemia, Bradycardia, and Multiple Laryngoscopy Attempts during Anesthetic Induction in Infants: A Single-center, Retrospective Study. Anesthesiology. 2019 Oct;131(4):830-839. doi: 10.1097/ALN.0000000000002847.

  PMID: 31335549 BACKGROUND

• Graciano AL, Tamburro R, Thompson AE, Fiadjoe J, Nadkarni VM, Nishisaki A. Incidence and associated factors of difficult tracheal intubations in pediatric ICUs: a report from National Emergency Airway Registry for Children: NEAR4KIDS. Intensive Care Med. 2014 Nov;40(11):1659-69. doi: 10.1007/s00134-014-3407-4. Epub 2014 Aug 27.

  PMID: 25160031 BACKGROUND

• 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.

  PMID: 23328260 BACKGROUND

• Garcia-Marcinkiewicz AG, Adams HD, Gurnaney H, Patel V, Jagannathan N, Burjek N, Mensinger JL, Zhang B, Peeples KN, Kovatsis PG, Fiadjoe JE; PeDI Collaborative. A Retrospective Analysis of Neuromuscular Blocking Drug Use and Ventilation Technique on Complications in the Pediatric Difficult Intubation Registry Using Propensity Score Matching. Anesth Analg. 2020 Aug;131(2):469-479. doi: 10.1213/ANE.0000000000004393.

  PMID: 31567318 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annery Garcia-Marcinikiewicz, MD

  The Children Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding of the device for clinicians and study staff is not feasible in this study. Participants will be blinded. The statisticians will be blinded at the time of generating the randomization schedule and remain blinded at the time of analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, multi-center parallel group trial

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: June 6, 2022
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)