Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

NCT ID: NCT02493478

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2030-01-31

Brief Summary

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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

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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.

Conditions

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Failed or Difficult Intubation, Sequela Intubation; Difficult Intubation Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vinay Nadkarni, MD. MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

Children's Hospital of Central California

Madera, California, United States

Site Status SUSPENDED

University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Yale New Haven Children's Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Yale-New Haven Children's Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Nemours Children's Health, Delaware

Wilmington, Delaware, United States

Site Status RECRUITING

Miami Children's Hospital

Miami, Florida, United States

Site Status SUSPENDED

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Children's Hospital of Atlanta - Scottish Rite

Atlanta, Georgia, United States

Site Status SUSPENDED

Children's Hospital of Georgia

Augusta, Georgia, United States

Site Status RECRUITING

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status RECRUITING

Beacon Children's Hospital

South Bend, Indiana, United States

Site Status SUSPENDED

Kentucky Children's Hospital

Lexington, Kentucky, United States

Site Status RECRUITING

Norton Children's Hospital - University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

Johns Hopkins Medicine

Baltimore, Maryland, United States

Site Status RECRUITING

University of Maryland

Baltimore, Maryland, United States

Site Status SUSPENDED

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status RECRUITING

Gillette Children's Specialty Health

Saint Paul, Minnesota, United States

Site Status SUSPENDED

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, United States

Site Status SUSPENDED

Children's Hospital and Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Morristown Medical Center

Morristown, New Jersey, United States

Site Status RECRUITING

Albany Medical College

Albany, New York, United States

Site Status RECRUITING

Oishei Children's Hospital

Buffalo, New York, United States

Site Status RECRUITING

Cohen Children's Medical Center

New Hyde Park, New York, United States

Site Status RECRUITING

New York Presbyterian Hospital Weill Cornell Medical College

New York, New York, United States

Site Status SUSPENDED

University of Rochester at Golisano Children's Hospital

Rochester, New York, United States

Site Status RECRUITING

Stony Brook Children's Hospital

Stony Brook, New York, United States

Site Status RECRUITING

The Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status SUSPENDED

Maria Fareri Children's Hospital (West Chester Medical)

Valhalla, New York, United States

Site Status RECRUITING

Duke Children's Hospital

Durham, North Carolina, United States

Site Status RECRUITING

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Site Status RECRUITING

WakeMed

Raleigh, North Carolina, United States

Site Status RECRUITING

Akron Children's Hospital

Akron, Ohio, United States

Site Status RECRUITING

Cincinnati Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Childrens Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Children's Hospital - Penn State Hershey

Hershey, Pennsylvania, United States

Site Status RECRUITING

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status SUSPENDED

Hasbro Children's Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Site Status SUSPENDED

Dell Children's Medical Center - Ascension

Austin, Texas, United States

Site Status RECRUITING

Medical City Children's Hospital

Dallas, Texas, United States

Site Status RECRUITING

Baylor - Christus Children's - Main Hospital

Irving, Texas, United States

Site Status RECRUITING

Baylor - Christus Children's - Westover Hills

San Antonio, Texas, United States

Site Status RECRUITING

Baylor - Christus Children's - Stone Oak

San Antonio, Texas, United States

Site Status RECRUITING

The University of Vermont Children's Hospital

Burlington, Vermont, United States

Site Status RECRUITING

UVA Children's Hospital

Charlottesville, Virginia, United States

Site Status RECRUITING

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Site Status SUSPENDED

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

University of Washington Medical Center

Seattle, Washington, United States

Site Status RECRUITING

University of Wisconsin - UnityPoint Meriter

Madison, Wisconsin, United States

Site Status RECRUITING

American Family Children's Hospital - University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin - American Family Children's Hospital

Shorewood Hills, Wisconsin, United States

Site Status RECRUITING

Royal Brisbane and Women's Hospital

Herston, , Australia

Site Status RECRUITING

The Royal Children's Hospital Melbourne

Parkville, , Australia

Site Status RECRUITING

Medical University of Vienna (Medizinische Universität Wien)

Vienna, , Austria

Site Status RECRUITING

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status RECRUITING

Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

The University of Manitoba

Winnipeg, , Canada

Site Status RECRUITING

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

Lübeck, , Germany

Site Status SUSPENDED

Aster Hospitals - India

Bengaluru, Karnataka, India

Site Status RECRUITING

Rainbow Children's Hospital

Bangalore, , India

Site Status SUSPENDED

Bambino Gesu

Roma, , Italy

Site Status SUSPENDED

National Center for Child Health and Development

Setagaya-Ku, Tokyo, Japan

Site Status RECRUITING

Hiroshima University

Hiroshima, , Japan

Site Status RECRUITING

Hyogo Prefectural Kobe Children's Hospital

Kobe, , Japan

Site Status RECRUITING

Aichi Children's Health and Medical Center

ÅŒbu, , Japan

Site Status RECRUITING

Saitama Children's Medical Center

Saitama, , Japan

Site Status RECRUITING

Jichi Medical University Hospital

Shimotsuke, , Japan

Site Status SUSPENDED

Tokyo Metropolitan

Tokyo, , Japan

Site Status RECRUITING

Starship Children's Hospital

Auckland, , New Zealand

Site Status SUSPENDED

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status RECRUITING

KK Women's & Children's Hospital, Singapore

Singapore, , Singapore

Site Status RECRUITING

Cardiff & Vale University Health Board

Cardiff, Wales, United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States Australia Austria Canada Germany India Italy Japan New Zealand Singapore United Kingdom

Central Contacts

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Hayley Buffman, MPH

Role: CONTACT

215-590-6772

Facility Contacts

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University of Alabama at Birmingham Institutional Review Board

Role: primary

205-934-3789

PCH IRB

Role: primary

602-933-1000

Office of Research and Sponsored Programs

Role: primary

501-686-5667

John Heldens

Role: primary

303-724-5000

Stephen Latham, JD, PhD

Role: primary

203-785-4688

John Giuliano, MD

Role: primary

Role: primary

302-651-4200

Pradip Kamat, MD

Role: primary

404-785-6397

Ashley Freeman

Role: primary

Role: primary

312-926-2000

Role: primary

317-944-5000

Ashwin Krishna, MD

Role: primary

Erin Owen, MD

Role: primary

Office of Human Subjects Research IRB

Role: primary

410-955-3008

Chinyere Egbuta

Role: primary

Julien Ginsberg-Peltz

Role: primary

Andrea Talukdar

Role: primary

Sholeen Nett, MD

Role: primary

603-650-5000

Atlantic Health System

Role: primary

973-971-5000

Role: primary

518-262-5521

Ryan Breuer, MD

Role: primary

Lily Glater

Role: primary

Adam Dziorny

Role: primary

Katherine Biagas, MD

Role: primary

Simon Li, MD

Role: primary

914-493-5941

Kyle Rehder, MD

Role: primary

919-681-3550

Mark Piehl

Role: primary

Elizabeth Woodard, RN, PhD

Role: primary

919-350-8795

Christopher Page-Goertz

Role: primary

Maya Dewan

Role: primary

Role: primary

216-444-5437

Anthony Lee, MD

Role: primary

614-722-3449

Paula Vanderford, MD

Role: primary

Ashley Derbyshire, MD

Role: primary

Kathleen May

Role: primary

717-531-5687

Elizabeth Foglia

Role: primary

Children's Hospital of Philadelphia IRB Office

Role: primary

215-590-2830

Lee Polikoff, MD

Role: primary

Role: primary

512-324-0000

Kris Bysani, MD

Role: primary

Baylor College of Medicine Office of Research

Role: primary

713-798-6970

Baylor College of Medicine Office of Research

Role: primary

713-798-6970

Baylor College of Medicine Office of Research

Role: primary

713-798-6970

Iris Toedt-Pingel, MD

Role: primary

Michelle Adu-Darko, MD

Role: primary

Alisyn Franetich

Role: primary

206-884-2910

Alisyn Franetich

Role: primary

206-884-2910

Liz Michaels

Role: primary

608-417-6411

Awni Al-Subu

Role: primary

Vickren Pillay

Role: primary

The University of Wisconsin IRB

Role: primary

608-263-2362

Role: primary

+61 7 3646 8111

Role: primary

+61 3 9345 5522

Role: primary

+43 1 401600

Role: primary

403-944-1110

Simon Parsons, MD

Role: primary

Gordon Krahn, MD

Role: primary

Guillaume Emeriaud, MD

Role: primary

Ahmed Moussa

Role: primary

Role: primary

(800) 432-1960

Role: primary

+91 80660 40400

Role: primary

+81 3-3416-0181

Nobuaki Shime

Role: primary

Yuki Nagai

Role: primary

Taka Ikeyama, MD

Role: primary

Takehiro Niitsu

Role: primary

Takanari Ikeyama, MD

Role: primary

Agnes Ng

Role: primary

65-6225-0488

Jan H Lee, MD

Role: primary

Role: primary

+44 29 2074 7747

References

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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.

Reference Type DERIVED
PMID: 29406378 (View on PubMed)

Other Identifiers

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R18HS022464

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

09-007253

Identifier Type: -

Identifier Source: org_study_id

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