Nasotracheal Intubation With VL vs DL in Infants Trial

NCT ID: NCT05433155

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2025-02-25

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.

Detailed Description

The primary objectives of the study are 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.

Secondary Objectives include the number of attempts for successful intubation; Incidence of failed NTI (conversion to oral intubation); Incidence of failure to intubate with assigned device; Incidence of complications over all attempts including non-severe and severe complications; Incidence of 1st-attempt complications; Need for cricoid pressure or external laryngeal manipulation, need for adjunct- (Magill forceps), rescue of one technique of the other, Percent of glottic opening (POGO) score less than 100%, intubation sequence exceeding 60 seconds and interaction analysis of weight group (i.e. ≤ median weight & > median weight (kg)), and by clinicians' experience with cardiac anesthesiology (i.e. Permanent full time team members & rotating team members) on the association between treatment and outcomes

Study Design: this is a prospective, randomized, multi-center parallel group trial

Setting/Participants: This will be a multi-center study. The target population will be infants 0-365 days of age scheduled for elective cardiothoracic surgery or cardiac catheterization requiring general anesthesia with NTI.

Study Interventions and Measures: The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL).

Main study outcome measures are as follows:

• The first intubation attempt success rate with each device
• The number of attempts for successful intubation with each device
• Complications associated with intubation

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Videolaryngoscopy

Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope

Group Type: ACTIVE_COMPARATOR

Nasotracheal intubation

Intervention Type: DEVICE

Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy

Direct Laryngoscopy

Nasotracheal Intubation performed with the standard clinical direct blades

Group Type: ACTIVE_COMPARATOR

Nasotracheal intubation

Intervention Type: DEVICE

Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy

Interventions

Nasotracheal intubation

Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 365 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Colorado

OTHER

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Children's Medical Center Dallas

OTHER

Sponsor Role: collaborator

Dell Children's Medical Center of Central Texas

OTHER

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annery Garcia-Marcinikiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

The Children Hospital of Philadelphia

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

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

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas at Austin Dell Children's Medical Center

Austin, Texas, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26705976 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33308472 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30198928 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30153543 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26482669 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18211452 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21680859 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26177215 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29862490 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25700237 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25552546 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23574475 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15271750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28492404 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28539007 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31335549 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25160031 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23328260 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31567318 (View on PubMed)

Other Identifiers

22-019921

Identifier Type: -

Identifier Source: org_study_id