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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02493478
Recruitment Status : Recruiting
First Posted : July 9, 2015
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease
Failed or Difficult Intubation, Sequela Intubation; Difficult Intubation Complication

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.

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Study Type : Observational
Estimated Enrollment : 150000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observation of Multi-center Quality Improvement Project: Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Study Start Date : March 2010
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2030



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493478


Contacts
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Contact: Hayley Buffman, MPH 215-590-6772 buffmanh@email.chop.edu

Locations
Show Show 33 study locations
Sponsors and Collaborators
Children's Hospital of Philadelphia
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Vinay Nadkarni, MD. MS Children's Hospital of Philadelphia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02493478    
Other Study ID Numbers: 09-007253
R18HS022464 ( U.S. AHRQ Grant/Contract )
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Keywords provided by Children's Hospital of Philadelphia:
Intubation
Advanced airway intervention
Intensive care unit