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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

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
NA
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03396432