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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03396432




Registration number
NCT03396432
Ethics application status
Date submitted
19/12/2017
Date registered
11/01/2018
Date last updated
25/03/2021

Titles & IDs
Public title
The Videolaryngoscopy in Small Infants
Scientific title
The Videolaryngoscopy in Small Infants (VISI) Trial
Secondary ID [1] 0 0
17-014302
Universal Trial Number (UTN)
Trial acronym
VISI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgery 0 0
Anesthesia, Endotracheal 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Video Laryngoscopy for ET placement
Treatment: Devices - Direct Laryngoscopy for ET Placement

Active comparator: Video Laryngoscopy for endotracheal (ET) Placement - Device:

Storz C-MAC Video Laryngoscope

Active comparator: Direct Laryngoscopy for ET Placement - Device:

Miller Laryngoscope


Treatment: Devices: Video Laryngoscopy for ET placement
Tracheal intubation performed with the Storz C-Mac Video Laryngoscope

Treatment: Devices: Direct Laryngoscopy for ET Placement
Tracheal Intubation performed with the Miller Blade
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Success in the First Attempt
Timepoint [1] 0 0
at the time of intubation
Secondary outcome [1] 0 0
Hypoxia
Timepoint [1] 0 0
At the time of intubation

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Males or females age 0 to <12 months.
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
Minimum age
No limit
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. History of difficult intubation
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
Accrual to date
Final
566
Recruitment in Australia
Recruitment state(s)
Pert
Recruitment hospital [1] 0 0
Princess Margaret Hospital For Children - Subiaco
Recruitment postcode(s) [1] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Hospital of Philadelphia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Anesthesia Patient Safety Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03396432
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
John Fiadjoe, MD
Address 0 0
Children's Hospital of Philadelphia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03396432