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Recruiting NCT02493478

Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

— Observational Failed or Difficult Intubation, Sequela Intubation; Difficult Intubation Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Failed or Difficult Intubation, Sequela, Intubation; Difficult, Intubation Complication. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Canada, Germany +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 63 centers
  • Children's of Alabama at Birmingham — Birmingham
  • Phoenix Children's Hospital — Phoenix
  • Arkansas Children's Hospital — Little Rock
  • Children's Hospital of Central California — Madera
  • University of Colorado Hospital — Aurora
  • Yale New Haven Children's Hospital — New Haven
  • Yale-New Haven Children's Hospital — New Haven
  • Nemours Children's Health, Delaware — Wilmington
  • … and 55 more centers
Japan · 7 centers
  • National Center for Child Health and Development — Setagaya-Ku
  • Hiroshima University — Hiroshima
  • Hyogo Prefectural Kobe Children's Hospital — Kobe
  • Aichi Children's Health and Medical Center — Ōbu
  • … and 3 more centers
Canada · 6 centers
  • Foothills Medical Centre — Calgary
  • Alberta Children's Hospital — Calgary
  • British Columbia Children's Hospital — Vancouver
  • CHU Sainte-Justine — Montreal
  • CHU Sainte-Justine — Montreal
  • The University of Manitoba — Winnipeg
Australia · 2 centers
  • Royal Brisbane and Women's Hospital — Herston
  • The Royal Children's Hospital Melbourne — Parkville
India · 2 centers
  • Aster Hospitals - India — Bengaluru
  • Rainbow Children's Hospital — Bangalore
Singapore · 2 centers

Center list to be confirmed — check the primary protocol.

Austria · 1 center
  • Medical University of Vienna (Medizinische Universität Wien) — Vienna
Germany · 1 center
  • University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital — Lübeck
Italy · 1 center
  • Bambino Gesu — Roma
New Zealand · 1 center

Center list to be confirmed — check the primary protocol.

United Kingdom · 1 center

Center list to be confirmed — check the primary protocol.

Publications

  • 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, Nishisa PMID 29406378

Identifiers

NCT: NCT02493478 · 09-007253 · R18HS022464

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗