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NCT02493478 Clinical Trial

Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

Intubation Complication Clinical Trial

— NEAR4KIDs  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02493478
Other study ID # 09-007253
Secondary ID R18HS022464
Status Recruiting
Phase
First received
Last updated
Start date March 2010
Est. completion date January 2030

Study information
Verified date January 2024
Source Children's Hospital of Philadelphia
Contact Hayley Buffman, MPH
Phone 215-590-6772
Email buffmanh@chop.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150000
Est. completion date January 2030
Est. primary completion date January 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Royal Brisbane and Women's Hospital Herston
Australia The Royal Children's Hospital Melbourne Parkville
Austria Medical University of Vienna (Medizinische Universität Wien) Vienna
Canada Alberta Children's Hospital Calgary Alberta
Canada Foothills Medical Centre Calgary Alberta
Canada CHU Sainte-Justine Montreal Quebec
Canada CHU Sainte-Justine Montréal Quebec
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada The University of Manitoba Winnipeg
Germany University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital Luebeck
India Rainbow Children's Hospital Bangalore
India Aster Hospitals - India Bengaluru Karnataka
Italy Bambino Gesu Roma
Japan Hiroshima University Hiroshima
Japan Hyogo Prefectural Kobe Children's Hospital Kobe
Japan Aichi Children's Health and Medical Center Obu
Japan Saitama Children's Medical Center Saitama
Japan National Center for Child Health and Development Setagaya-Ku Tokyo
Japan Jichi Medical University Hospital Shimotsuke
Japan Tokyo Metropolitan Tokyo
New Zealand Starship Children's Hospital Auckland
Singapore KK Women's & Children's Hospital, Singapore Singapore
Singapore KK Women's and Children's Hospital Singapore
United Kingdom Cardiff & Vale University Health Board Cardiff Wales
United States Akron Children's Hospital Akron Ohio
United States Albany Medical College Albany New York
United States Children's Hospital of Atlanta - Scottish Rite Atlanta Georgia
United States Emory University Atlanta Georgia
United States Children's Hospital of Georgia Augusta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Dell Children's Medical Center - Ascension Austin Texas
United States University of Maryland Baltimore Maryland
United States Boston Children's Hospital Boston Massachusetts
United States The Children's Hospital at Montefiore Bronx New York
United States Oishei Children's Hospital Buffalo New York
United States The University of Vermont Children's Hospital Burlington Vermont
United States UVA Children's Hospital Charlottesville Virginia
United States Northwestern Medicine Prentice Women's Hospital Chicago Illinois
United States Cincinnati Hospital Medical Center Cincinnati Ohio
United States Cleveland Clinic Childrens Hospital Cleveland Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States Medical City Children's Hospital Dallas Texas
United States Duke Children's Hospital Durham North Carolina
United States Children's Hospital - Penn State Hershey Hershey Pennsylvania
United States Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania
United States Riley Hospital for Children Indianapolis Indiana
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Kentucky Children's Hospital Lexington Kentucky
United States Arkansas Children's Hospital Little Rock Arkansas
United States Norton Children's Hospital - University of Louisville Louisville Kentucky
United States Children's Hospital of Central California Madera California
United States American Family Children's Hospital - University of Wisconsin Madison Wisconsin
United States Le Bonheur Children's Hospital Memphis Tennessee
United States Miami Children's Hospital Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Yale New Haven Children's Hospital New Haven Connecticut
United States Yale-New Haven Children's Hospital New Haven Connecticut
United States Cohen Children's Medical Center New Hyde Park New York
United States New York Presbyterian Hospital Weill Cornell Medical College New York New York
United States Children's Hospital and Medical Center Omaha Nebraska
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Hasbro Children's Hospital Providence Rhode Island
United States WakeMed Raleigh North Carolina
United States WakeMed Health & Hospitals Raleigh North Carolina
United States Children's Hospital of Richmond at VCU Richmond Virginia
United States University of Rochester at Golisano Children's Hospital Rochester New York
United States Children's Hospitals and Clinics of Minnesota Saint Paul Minnesota
United States Gillette Children's Specialty Health Saint Paul Minnesota
United States Seattle Children's Hospital Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Beacon Children's Hospital South Bend Indiana
United States Baystate Medical Center Springfield Massachusetts
United States Stony Brook Children's Hospital Stony Brook New York
United States Maria Fareri Children's Hospital (West Chester Medical) Valhalla New York
United States Nemours Children's Health, Delaware Wilmington Delaware

Sponsors (2)
Lead Sponsor Collaborator
Children's Hospital of Philadelphia Agency for Healthcare Research and Quality (AHRQ)

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Germany,  India,  Italy,  Japan,  New Zealand,  Singapore,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in number of tracheal intubation associated events (TIAEs) 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
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Active, not recruiting NCT06108271 - Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury N/A
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Completed NCT04079387 - Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone N/A