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Trial details imported from ClinicalTrials.gov

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02493478