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

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT02493478

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

150,000

Enrollment

Locations

238.1

Duration (Months)

2272.7

Patients Per Site

9.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Mar 1, 2010

Anticipated Primary Completion Date :

Jan 1, 2030

Anticipated Study Completion Date :

Jan 1, 2030

Outcome Measures

Primary Outcome Measures

Change in number of tracheal intubation associated events (TIAEs) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hospital	Phoenix	Arizona	United States	85006
2	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202
3	Children's Hospital of Central California	Madera	California	United States	93636
4	University of Colorado Hospital	Aurora	Colorado	United States	80045
5	Yale New Haven Children's Hospital	New Haven	Connecticut	United States	06510
6	Yale-New Haven Children's Hospital	New Haven	Connecticut	United States	06510
7	Miami Children's Hospital	Miami	Florida	United States	33155
8	Emory University	Atlanta	Georgia	United States	30322
9	Children's Hospital of Atlanta - Scottish Rite	Atlanta	Georgia	United States	30342
10	Children's Hospital of Georgia	Augusta	Georgia	United States	30912
11	Beacon Children's Hospital	South Bend	Indiana	United States	46601
12	Kentucky Children's Hospital	Lexington	Kentucky	United States	40536
13	Norton Children's Hospital - University of Louisville	Louisville	Kentucky	United States	40202
14	University of Maryland	Baltimore	Maryland	United States	21230
15	Boston Children's Hospital	Boston	Massachusetts	United States	02115
16	Baystate Medical Center	Springfield	Massachusetts	United States	01199
17	Gillette Children's Specialty Health	Saint Paul	Minnesota	United States	55101
18	Children's Hospitals and Clinics of Minnesota	Saint Paul	Minnesota	United States	55404
19	Children's Hospital and Medical Center	Omaha	Nebraska	United States	68114
20	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766
21	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766
22	The Children's Hospital at Montefiore	Bronx	New York	United States	10467
23	Oishei Children's Hospital	Buffalo	New York	United States	14222
24	Cohen Children's Medical Center	New Hyde Park	New York	United States	11040
25	New York Presbyterian Hospital Weill Cornell Medical College	New York	New York	United States	10065
26	University of Rochester at Golisano Children's Hospital	Rochester	New York	United States	14642
27	Stony Brook Children's Hospital	Stony Brook	New York	United States	11794
28	Maria Fareri Children's Hospital (West Chester Medical)	Valhalla	New York	United States	10595
29	Duke Children's Hospital	Durham	North Carolina	United States	27705
30	WakeMed Health & Hospitals	Raleigh	North Carolina	United States	27610
31	WakeMed	Raleigh	North Carolina	United States	27610
32	Akron Children's Hospital	Akron	Ohio	United States	44308
33	Cincinnati Hospital Medical Center	Cincinnati	Ohio	United States	45229
34	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
35	Oregon Health and Science University	Portland	Oregon	United States	97239
36	Children's Hospital - Penn State Hershey	Hershey	Pennsylvania	United States	17033
37	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
38	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
39	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
40	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224
41	Hasbro Children's Hospital	Providence	Rhode Island	United States	02903
42	Le Bonheur Children's Hospital	Memphis	Tennessee	United States	38103
43	Medical City Children's Hospital	Dallas	Texas	United States	75230
44	The University of Vermont Children's Hospital	Burlington	Vermont	United States	05401
45	UVA Children's Hospital	Charlottesville	Virginia	United States	22903
46	Children's Hospital of Richmond at VCU	Richmond	Virginia	United States	23298
47	Seattle Children's Hospital	Seattle	Washington	United States	98105
48	University of Washington Medical Center	Seattle	Washington	United States	98195
49	American Family Children's Hospital - University of Wisconsin	Madison	Wisconsin	United States	53792
50	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
51	Alberta Children's Hospital	Calgary	Alberta	Canada	T3B 6A9
52	British Columbia Children's Hospital	Vancouver	British Columbia	Canada	V6H 3V4
53	CHU Sainte-Justine	Montreal	Quebec	Canada	H3T 1C4
54	CHU Sainte-Justine	Montréal	Quebec	Canada	QC H3T 1C5
55	University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital	Luebeck		Germany	23562
56	Rainbow Children's Hospital	Bangalore		India	560092
57	Bambino Gesu	Roma		Italy	00165
58	Hiroshima University	Hiroshima		Japan	734-8551
59	Hyogo Prefectural Kobe Children's Hospital	Kobe		Japan	650-0047
60	Aichi Children's Health and Medical Center	Obu		Japan
61	Saitama Children's Medical Center	Saitama		Japan	350-0451
62	Jichi Medical University Hospital	Shimotsuke		Japan	329-0431
63	Tokyo Metropolitan	Tokyo		Japan	163-8001
64	Starship Children's Hospital	Auckland		New Zealand	1023
65	KK Women's and Children's Hospital	Singapore		Singapore	168753
66	KK Women's & Children's Hospital, Singapore	Singapore		Singapore	229899

Sponsors and Collaborators

Children's Hospital of Philadelphia
Agency for Healthcare Research and Quality (AHRQ)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital of Philadelphia

ClinicalTrials.gov Identifier:

NCT02493478

Other Study ID Numbers:

09-007253
R18HS022464

First Posted:

Jul 9, 2015

Last Update Posted:

Feb 23, 2022

Last Verified:

Feb 1, 2022

Keywords provided by Children's Hospital of Philadelphia

Intubation

Advanced airway intervention

Intensive care unit

Study Results

No Results Posted as of Feb 23, 2022