Study Results
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View full resultsBasic Information
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COMPLETED
NA
566 participants
INTERVENTIONAL
2018-06-04
2020-12-31
Brief Summary
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Detailed Description
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* Primary Objective To compare the tracheal intubation (TI) first attempt success rate using VL vs. DL in children ≤ 12 months old.
* Secondary Objectives To compare the lowest oxygen saturation during tracheal intubation with VL vs. DL.
Study Design:
Prospective, randomized, multi-center parallel group trial
Setting/Participants:
This will be a multi-center study with a minimum of four participating centers. The target population will be children ≤ 12 months age scheduled for elective surgery requiring general anesthesia with endotracheal intubation.
Study Interventions and Measures:
The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Miller 1 (VL) or the conventional Miller 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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Video Laryngoscopy for endotracheal (ET) Placement
Device:
Storz C-MAC Video Laryngoscope
Video Laryngoscopy for ET placement
Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement
Tracheal Intubation performed with the Miller Blade
Direct Laryngoscopy for ET Placement
Device:
Miller Laryngoscope
Video Laryngoscopy for ET placement
Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement
Tracheal Intubation performed with the Miller Blade
Interventions
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Video Laryngoscopy for ET placement
Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement
Tracheal Intubation performed with the Miller Blade
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Subject/Parental/guardian permission (informed consent).
Inclusion for clinician participants:
1\) Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident
Exclusion Criteria
2. History with abnormal airway
3. Predictive of difficult intubation upon physical examination
4. Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent
12 Months
ALL
No
Sponsors
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Anesthesia Patient Safety Foundation
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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John Fiadjoe, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Princess Margaret Hospital For Children
Subiaco, Perth, Australia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Souza Nd, Carvalho WB. [Complications of tracheal intubation in pediatrics]. Rev Assoc Med Bras (1992). 2009 Nov-Dec;55(6):646-50. Portuguese.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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17-014302
Identifier Type: -
Identifier Source: org_study_id
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