NCT02493478

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
10 countries

86 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Mar 2010Jan 2030

Study Start

First participant enrolled

March 1, 2010

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

19.9 years

First QC Date

July 6, 2015

Last Update Submit

January 8, 2026

Conditions

Keywords

IntubationAdvanced airway interventionIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (87)

Children's of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, 85006, United States

RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

Children's Hospital of Central California

Madera, California, 93636, United States

SUSPENDED

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Yale New Haven Children's Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Yale-New Haven Children's Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Nemours Children's Health, Delaware

Wilmington, Delaware, 19803, United States

RECRUITING

Miami Children's Hospital

Miami, Florida, 33155, United States

SUSPENDED

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Children's Hospital of Atlanta - Scottish Rite

Atlanta, Georgia, 30342, United States

SUSPENDED

Children's Hospital of Georgia

Augusta, Georgia, 30912, United States

RECRUITING

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Beacon Children's Hospital

South Bend, Indiana, 46601, United States

SUSPENDED

Kentucky Children's Hospital

Lexington, Kentucky, 40536, United States

RECRUITING

Norton Children's Hospital - University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21230, United States

SUSPENDED

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

Gillette Children's Specialty Health

Saint Paul, Minnesota, 55101, United States

SUSPENDED

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, 55404, United States

SUSPENDED

Children's Hospital and Medical Center

Omaha, Nebraska, 68114, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Albany Medical College

Albany, New York, 12208, United States

RECRUITING

Oishei Children's Hospital

Buffalo, New York, 14222, United States

RECRUITING

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

New York Presbyterian Hospital Weill Cornell Medical College

New York, New York, 10065, United States

SUSPENDED

University of Rochester at Golisano Children's Hospital

Rochester, New York, 14642, United States

RECRUITING

Stony Brook Children's Hospital

Stony Brook, New York, 11794, United States

RECRUITING

The Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

SUSPENDED

Maria Fareri Children's Hospital (West Chester Medical)

Valhalla, New York, 10595, United States

RECRUITING

Duke Children's Hospital

Durham, North Carolina, 27705, United States

RECRUITING

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

RECRUITING

WakeMed

Raleigh, North Carolina, 27610, United States

RECRUITING

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

Cincinnati Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Cleveland Clinic Childrens Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Children's Hospital - Penn State Hershey

Hershey, Pennsylvania, 17033, United States

RECRUITING

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

SUSPENDED

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

SUSPENDED

Dell Children's Medical Center - Ascension

Austin, Texas, 78723, United States

RECRUITING

Medical City Children's Hospital

Dallas, Texas, 75230, United States

RECRUITING

Baylor - Christus Children's - Main Hospital

Irving, Texas, 75039, United States

RECRUITING

Baylor - Christus Children's - Westover Hills

San Antonio, Texas, 78251, United States

RECRUITING

Baylor - Christus Children's - Stone Oak

San Antonio, Texas, 78258, United States

RECRUITING

The University of Vermont Children's Hospital

Burlington, Vermont, 05401, United States

RECRUITING

UVA Children's Hospital

Charlottesville, Virginia, 22903, United States

RECRUITING

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298, United States

SUSPENDED

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

University of Wisconsin - UnityPoint Meriter

Madison, Wisconsin, 53715, United States

RECRUITING

American Family Children's Hospital - University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

University of Wisconsin - American Family Children's Hospital

Shorewood Hills, Wisconsin, 53792, United States

RECRUITING

Royal Brisbane and Women's Hospital

Herston, 4006, Australia

RECRUITING

The Royal Children's Hospital Melbourne

Parkville, 3052, Australia

RECRUITING

Medical University of Vienna (Medizinische Universität Wien)

Vienna, Spitalgasse 23, Austria

RECRUITING

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Alberta Children's Hospital

Calgary, Alberta, T3B 6A9, Canada

RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, H3T 1C4, Canada

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, QC H3T 1C5, Canada

RECRUITING

The University of Manitoba

Winnipeg, B R3T 2N2, Canada

RECRUITING

University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital

Lübeck, 23562, Germany

SUSPENDED

Aster Hospitals - India

Bengaluru, Karnataka, 560078, India

RECRUITING

Rainbow Children's Hospital

Bangalore, 560092, India

SUSPENDED

Bambino Gesu

Roma, 00165, Italy

SUSPENDED

National Center for Child Health and Development

Setagaya-Ku, Tokyo, 157-8535, Japan

RECRUITING

Hiroshima University

Hiroshima, 734-8551, Japan

RECRUITING

Hyogo Prefectural Kobe Children's Hospital

Kobe, 650-0047, Japan

RECRUITING

Aichi Children's Health and Medical Center

Ōbu, Japan

RECRUITING

Saitama Children's Medical Center

Saitama, 350-0451, Japan

RECRUITING

Jichi Medical University Hospital

Shimotsuke, 329-0431, Japan

SUSPENDED

Tokyo Metropolitan

Tokyo, 163-8001, Japan

RECRUITING

Starship Children's Hospital

Auckland, 1023, New Zealand

SUSPENDED

KK Women's and Children's Hospital

Singapore, 168753, Singapore

RECRUITING

KK Women's & Children's Hospital, Singapore

Singapore, 229899, Singapore

RECRUITING

Cardiff & Vale University Health Board

Cardiff, Wales, CF14 4XW, United Kingdom

NOT YET RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Vinay Nadkarni, MD. MS

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayley Buffman, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 9, 2015

Study Start

March 1, 2010

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations