The Videolaryngoscopy in Small Infants

NCT03396432 | Completed Results FDA Device

• 1 other identifier: 17-014302
• Study Type: interventional
• Target: 566
• Locations: 2 countries
• Sites: 5

Brief Summary

Complications related to infant (≤ 1 year) airway management are under-appreciated because of few rigorous and targeted studies. Investigators have recently shown that multiple tracheal intubation (TI) attempts are a key risk factor for intubation-related complications in small children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in anesthesiology practice because of several advantages over conventional direct laryngoscopy (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer intubation attempts, but may take more time to intubate the trachea. This study compares first attempt success of VL to DL in infants presenting for elective surgery.

Conditions

Surgery; Anesthesia, Endotracheal

Keywords

laryngoscope; intubation; first attempt success; oxygen saturation; airway management; Videolaryngoscopy; Direct laryngoscopy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Success in the First Attempt

  comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL

  at the time of intubation

Secondary Outcomes (1)

• Hypoxia

  At the time of intubation

Study Arms (2)

Video Laryngoscopy for endotracheal (ET) Placement

ACTIVE COMPARATOR

Device: Storz C-MAC Video Laryngoscope

Device: Video Laryngoscopy for ET placement; Device: Direct Laryngoscopy for ET Placement

Direct Laryngoscopy for ET Placement

ACTIVE COMPARATOR

Device: Miller Laryngoscope

Device: Video Laryngoscopy for ET placement; Device: Direct Laryngoscopy for ET Placement

Interventions

Video Laryngoscopy for ET placement DEVICE

Tracheal intubation performed with the Storz C-Mac Video Laryngoscope

Direct Laryngoscopy for ET Placement; Video Laryngoscopy for endotracheal (ET) Placement

Direct Laryngoscopy for ET Placement DEVICE

Tracheal Intubation performed with the Miller Blade

Direct Laryngoscopy for ET Placement; Video Laryngoscopy for endotracheal (ET) Placement

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females age 0 to \<12 months.
• Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under general anesthesia where oral endotracheal intubation will be performed by an anesthesiology clinician.
• Subject/Parental/guardian permission (informed consent).
• \) Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident

You may not qualify if:

• History of difficult intubation
• History with abnormal airway
• Predictive of difficult intubation upon physical examination
• Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Anesthesia Patient Safety Foundation: collaborator

Study Sites (5)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Princess Margaret Hospital For Children

Subiaco, Perth, Australia

Location

Related Publications (13)

• 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

• 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, Shaw TL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2015 Feb 18;(2):CD009975. doi: 10.1002/14651858.CD009975.pub2.

  PMID: 25691129 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

• Souza Nd, Carvalho WB. [Complications of tracheal intubation in pediatrics]. Rev Assoc Med Bras (1992). 2009 Nov-Dec;55(6):646-50. Portuguese.

  PMID: 20191217 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

• Nouruzi-Sedeh P, Schumann M, Groeben H. Laryngoscopy via Macintosh blade versus GlideScope: success rate and time for endotracheal intubation in untrained medical personnel. Anesthesiology. 2009 Jan;110(1):32-7. doi: 10.1097/ALN.0b013e318190b6a7.

  PMID: 19104167 BACKGROUND

• Howard-Quijano KJ, Huang YM, Matevosian R, Kaplan MB, Steadman RH. Video-assisted instruction improves the success rate for tracheal intubation by novices. Br J Anaesth. 2008 Oct;101(4):568-72. doi: 10.1093/bja/aen211. Epub 2008 Aug 1.

  PMID: 18676418 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 DERIVED

Results Point of Contact

• Title: Dr. John Fiadjoe, PI
• Organization: Children Hospital of Philadelphia

fiadjoej@email.chop.edu

267-426-2961

Study Officials

• John Fiadjoe, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician will be blinded at the time of data analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 11, 2018
• Study Start: June 4, 2018
• Primary Completion: August 19, 2019
• Study Completion: December 31, 2020
• Last Updated: March 25, 2021
• Results First Posted: September 21, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); AU (1)