Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02493478




Registration number
NCT02493478
Ethics application status
Date submitted
6/07/2015
Date registered
9/07/2015
Date last updated
18/01/2024

Titles & IDs
Public title
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Scientific title
Observation of Multi-center Quality Improvement Project: Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Secondary ID [1] 0 0
R18HS022464
Secondary ID [2] 0 0
09-007253
Universal Trial Number (UTN)
Trial acronym
NEAR4KIDs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Failed or Difficult Intubation, Sequela 0 0
Intubation; Difficult 0 0
Intubation Complication 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in number of tracheal intubation associated events (TIAEs)
Timepoint [1] 0 0
participants will be followed for the duration of their hospital stay, an expected average of 4 weeks

Eligibility
Key inclusion criteria
- Primary advanced airway events (on patients of all ages) in the PICU, CICU, NICU, DR
and ED including: Tracheal Intubation, Laryngeal mask placement, Emergency
tracheostomy and/or cricothyrotomy

- Failed extubation attempts or unplanned extubations that require re-intubation will be
considered a new primary intubation.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Primary advanced airway events (tracheal intubations, laryngeal mask placement,
emergency tracheostomy and/or cricothyrotomy) in the Operating Suites.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2030
Actual
Sample size
Target
150000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
The Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Minnesota
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Nebraska
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New Hampshire
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Vermont
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Virginia
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Washington
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Wisconsin
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Austria
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Vienna
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Quebec
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Canada
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Winnipeg
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Germany
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Luebeck
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India
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Karnataka
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India
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Bangalore
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Italy
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Roma
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Japan
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Tokyo
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Japan
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Hiroshima
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Japan
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Kobe
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Japan
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Obu
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Japan
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Saitama
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Japan
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Shimotsuke
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New Zealand
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Auckland
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Singapore
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Singapore
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United Kingdom
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Wales

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Hospital of Philadelphia
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Agency for Healthcare Research and Quality (AHRQ)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Advanced airway interventions are common high risk, high stakes events for children in
intensive care units (ICU) and emergency departments (ED), with risk for life and health
threatening consequences.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02493478
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vinay Nadkarni, MD. MS
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
Hayley Buffman, MPH
Address 0 0
Country 0 0
Phone 0 0
215-590-6772
Fax 0 0
Email 0 0
buffmanh@chop.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02493478