Clinical trial NCT02493478: Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Official title: Observation of Multi-center Quality Improvement Project: Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Failed or Difficult Intubation, Sequela
Intubation; Difficult
Intubation Complication
Keywords: Intubation
Advanced airway intervention
Intensive care unit
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-07-09
Enrollment: 150000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of tracheal intubation associated events (TIAEs)
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Madera
country: United States
facility: Children's Hospital of Central California
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Children's Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Children's Hospital
state: Connecticut
city: Wilmington
country: United States
facility: Nemours Children's Health, Delaware
state: Delaware
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Children's Hospital of Atlanta - Scottish Rite
state: Georgia
city: Augusta
country: United States
facility: Children's Hospital of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine Prentice Women's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: South Bend
country: United States
facility: Beacon Children's Hospital
state: Indiana
city: Lexington
country: United States
facility: Kentucky Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Children's Hospital - University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Health
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: Children's Hospital and Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Bronx
country: United States
facility: The Children's Hospital at Montefiore
state: New York
city: Buffalo
country: United States
facility: Oishei Children's Hospital
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester at Golisano Children's Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Children's Hospital
state: New York
city: Valhalla
country: United States
facility: Maria Fareri Children's Hospital (West Chester Medical)
state: New York
city: Durham
country: United States
facility: Duke Children's Hospital
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Childrens Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Children's Hospital - Penn State Hershey
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center - Ascension
state: Texas
city: Dallas
country: United States
facility: Medical City Children's Hospital
state: Texas
city: Irving
country: United States
facility: Baylor - Christus Children's - Main Hospital
state: Texas
city: San Antonio
country: United States
facility: Baylor - Christus Children's - Westover Hills
state: Texas
city: San Antonio
country: United States
facility: Baylor - Christus Children's - Stone Oak
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Children's Hospital
state: Vermont
city: Charlottesville
country: United States
facility: UVA Children's Hospital
state: Virginia
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - UnityPoint Meriter
state: Wisconsin
city: Madison
country: United States
facility: American Family Children's Hospital - University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Shorewood Hills
country: United States
facility: University of Wisconsin - American Family Children's Hospital
state: Wisconsin
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Parkville
country: Australia
facility: The Royal Children's Hospital Melbourne
city: Vienna
country: Austria
facility: Medical University of Vienna (Medizinische Universität Wien)
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Winnipeg
country: Canada
facility: The University of Manitoba
city: Luebeck
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital
city: Bengaluru
country: India
facility: Aster Hospitals - India
state: Karnataka
city: Bangalore
country: India
facility: Rainbow Children's Hospital
city: Roma
country: Italy
facility: Bambino Gesu
city: Setagaya-Ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima University
city: Kobe
country: Japan
facility: Hyogo Prefectural Kobe Children's Hospital
city: Obu
country: Japan
facility: Aichi Children's Health and Medical Center
city: Saitama
country: Japan
facility: Saitama Children's Medical Center
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan
city: Auckland
country: New Zealand
facility: Starship Children's Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: KK Women's & Children's Hospital, Singapore
city: Cardiff
country: United Kingdom
facility: Cardiff & Vale University Health Board
state: Wales
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Vinay Nadkarni, MD. MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabrani A, Kojima T, Sanders RC Jr, Shenoi A, Montgomery V, Parsons SJ, Gangadharan S, Nett S, Napolitano N, Tarquinio K, Simon DW, Lee A, Emeriaud G, Adu-Darko M, Giuliano JS Jr, Meyer K, Graciano AL, Turner DA, Krawiec C, Bakar AM, Polikoff LA, Parker M, Harwayne-Gidansky I, Crulli B, Vanderford P, Breuer RK, Gradidge E, Branca A, Glater-Welt LB, Tellez D, Wright LV, Pinto M, Nadkarni V, Nishisaki A; National Emergency Airway Registry for Children (NEAR4KIDS) Collaborators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI). Downward Trend in Pediatric Resident Laryngoscopy Participation in PICUs. Pediatr Crit Care Med. 2018 May;19(5):e242-e250. doi: 10.1097/PCC.0000000000001470.