Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs (NEAR4KIDs)

January 17, 2024 updated by: Children's Hospital of Philadelphia

Observation of Multi-center Quality Improvement Project: Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study will evaluate local pediatric intensive care unit (PICU), cardiac intensive care unit (CICU) and neonatal intensive care unit (NICU) as well as EDs and delivery room (DR) practice, and benchmark against other PICUs, CICUs, NICUs, DRs and EDs as a part of Multi-Center Airway Safety collaborative network (NEAR4KIDS).

The goal of the study is to utilize collected benchmarked data to improve local practice. In order to develop this quality improvement (QI) intervention and collaboration, it is necessary to collect baseline data to describe current practice and to continuously evaluate the effectiveness of any QI intervention.

Study Type

Observational

Enrollment (Estimated)

150000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Herston, Australia, 4006
        • Recruiting
        • Royal Brisbane and Women's Hospital
        • Contact:
          • Phone Number: +61 7 3646 8111
        • Principal Investigator:
          • Kate Hodgson
      • Parkville, Australia, 3052
        • Recruiting
        • The Royal Children's Hospital Melbourne
        • Contact:
          • Phone Number: +61 3 9345 5522
        • Principal Investigator:
          • David Tingay
  • Austria
      • Vienna, Austria, Spitalgasse 23
        • Recruiting
        • Medical University of Vienna (Medizinische Universität Wien)
        • Principal Investigator:
          • Michael Wagner
        • Contact:
          • Phone Number: +43 1 401600
  • Canada
      • Winnipeg, Canada, B R3T 2N2
        • Recruiting
        • The University of Manitoba
        • Contact:
          • Phone Number: (800) 432-1960
        • Principal Investigator:
          • Michael Narvey
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Recruiting
        • Foothills Medical Centre
        • Contact:
          • Phone Number: 403-944-1110
        • Principal Investigator:
          • Ayman About Mehrem
      • Calgary, Alberta, Canada, T3B 6A9
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • British Columbia Children's Hospital
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C4
      • Montréal, Quebec, Canada, QC H3T 1C5
        • Recruiting
        • CHU Sainte-Justine
        • Contact:
          • Ahmed Moussa
  • Germany
      • Luebeck, Germany, 23562
        • Suspended
        • University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital
  • India
      • Bangalore, India, 560092
        • Suspended
        • Rainbow Children's Hospital
    • Karnataka
      • Bengaluru, Karnataka, India, 560078
        • Recruiting
        • Aster Hospitals - India
        • Contact:
          • Phone Number: +91 80660 40400
        • Principal Investigator:
          • Sujatha Thyagarajan
  • Italy
      • Roma, Italy, 00165
        • Recruiting
        • Bambino Gesu
        • Contact:
          • Fabrizio Chiusolo
  • Japan
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University
        • Contact:
          • Nobuaki Shime
      • Kobe, Japan, 650-0047
        • Recruiting
        • Hyogo prefectural Kobe Children's Hospital
        • Contact:
          • Yuki Nagai
      • Obu, Japan
        • Recruiting
        • Aichi Children's Health and Medical Center
        • Contact:
          • Taka Ikeyama, MD
      • Saitama, Japan, 350-0451
        • Recruiting
        • Saitama Children's Medical Center
        • Contact:
          • Takehiro Niitsu
      • Shimotsuke, Japan, 329-0431
        • Suspended
        • Jichi Medical University Hospital
      • Tokyo, Japan, 163-8001
        • Recruiting
        • Tokyo Metropolitan
        • Contact:
    • Tokyo
      • Setagaya-Ku, Tokyo, Japan, 157-8535
        • Recruiting
        • National Center for Child Health and Development
        • Contact:
          • Phone Number: +81 3-3416-0181
        • Principal Investigator:
          • Masafumi Gima
  • New Zealand
      • Auckland, New Zealand, 1023
        • Suspended
        • Starship Children's Hospital
  • Singapore
      • Singapore, Singapore, 168753
        • Recruiting
        • KK Women's and Children's Hospital
        • Contact:
          • Agnes Ng
          • Phone Number: 65-6225-0488
        • Principal Investigator:
          • Quek Bin Huey, MD
      • Singapore, Singapore, 229899
  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • Not yet recruiting
        • Cardiff & Vale University Health Board
        • Contact:
          • Phone Number: +44 29 2074 7747
        • Principal Investigator:
          • Anna Barrow
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
    • California
      • Madera, California, United States, 93636
        • Suspended
        • Children's Hospital of Central California
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Contact:
        • Principal Investigator:
          • James Barrd, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Children's Hospital
        • Contact:
        • Principal Investigator:
          • Lindsay Johnston, MD
      • New Haven, Connecticut, United States, 06510
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours Children's Health, Delaware
        • Contact:
          • Phone Number: 302-651-4200
        • Principal Investigator:
          • Kimberly McMahon
    • Florida
      • Miami, Florida, United States, 33155
        • Suspended
        • Miami Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
      • Atlanta, Georgia, United States, 30342
        • Suspended
        • Children's Hospital of Atlanta - Scottish Rite
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Children's Hospital of Georgia
        • Contact:
          • Ashley Freeman
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine Prentice Women's Hospital
        • Contact:
          • Phone Number: 312-926-2000
        • Principal Investigator:
          • Nicole Pouppirt
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
          • Phone Number: 317-944-5000
        • Principal Investigator:
          • Samer Abu-Sultaneh
      • South Bend, Indiana, United States, 46601
        • Suspended
        • Beacon Children's Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Hospital - University of Louisville
        • Contact:
          • Erin Owen, MD
    • Maryland
      • Baltimore, Maryland, United States, 21230
        • Suspended
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
          • Chinyere Egbuta
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Medical Center
        • Contact:
          • Julien Ginsberg-Peltz
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Suspended
        • Gillette Children's Specialty Health
      • Saint Paul, Minnesota, United States, 55404
        • Suspended
        • Children's Hospitals and Clinics of Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital and Medical Center
        • Contact:
          • Andrea Talukdar
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Contact:
          • Phone Number: 518-262-5521
        • Principal Investigator:
          • Ilana Harwayne-Gidansky
      • Bronx, New York, United States, 10467
        • Suspended
        • The Children's Hospital at Montefiore
      • Buffalo, New York, United States, 14222
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Cohen Children's Medical Center
        • Contact:
          • Lily Glater
      • New York, New York, United States, 10065
        • Suspended
        • New York Presbyterian Hospital Weill Cornell Medical College
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester at Golisano Children's Hospital
        • Contact:
          • Adam Dziorny
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook Children's Hospital
        • Contact:
          • Katherine Biagas, MD
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Maria Fareri Children's Hospital (West Chester Medical)
        • Contact:
          • Simon Li, MD
          • Phone Number: 914-493-5941
          • Email: lis@WCMC.com
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Children's Hospital
        • Contact:
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed
        • Contact:
        • Principal Investigator:
          • Stephen D DeMeo, DO
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed Health & Hospitals
        • Contact:
          • Mark Piehl
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Akron Children's Hospital
        • Contact:
          • Christopher Page-Goertz
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Hospital Medical Center
        • Contact:
          • Maya Dewan
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic Childrens Hospital
        • Contact:
          • Phone Number: 216-444-5437
        • Principal Investigator:
          • Sabine Iben
      • Columbus, Ohio, United States, 43205
        • Suspended
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health Milton S. Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Kristen Glass, MD
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Children's Hospital - Penn State Hershey
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Children's Hospital of Philadelphia
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
          • Elizabeth Foglia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Suspended
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Suspended
        • Le Bonheur Children's Hospital
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's Medical Center - Ascension
        • Contact:
          • Phone Number: 512-324-0000
        • Principal Investigator:
          • Hunter Daigle
      • Dallas, Texas, United States, 75230
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Charlottesville, Virginia, United States, 22903
      • Richmond, Virginia, United States, 23298
        • Suspended
        • Children's Hospital of Richmond at VCU
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:
        • Principal Investigator:
          • Taylor Sawyer, MD
      • Seattle, Washington, United States, 98105
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • American Family Children's Hospital - University of Wisconsin
        • Contact:
          • Awni Al-Subu
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Vickren Pillay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and cricothyrotomy) in PICUs, CICUs, NICUs, DRs and EDs during study period. Information regarding airway management events as well as select information regarding circumstances up to the event will be collected.

Description

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.

Exclusion Criteria:

  • Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of tracheal intubation associated events (TIAEs)
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 4 weeks
The number of TIAEs during primary tracheal intubation will be compared to any TIAEs documented during subsequent intubation attempts.
participants will be followed for the duration of their hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Vinay Nadkarni, MD. MS, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimated)

July 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09-007253
  • R18HS022464 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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