Failed or Difficult Intubation, SequelaNEAR4KIDsNCT02493478
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
An observational study of Failed or Difficult Intubation, Sequela and Intubation; Difficult, run by Children's Hospital of Philadelphia at 87 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Failed or Difficult Intubation, Sequela, Intubation; Difficult, Intubation Complication
- How many people
- 150,000 participants
- Where
- 87 sitesin 11 countries
- Study dates
- Mar 2010to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites.
Trial locations and contacts
87 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
87 sites in 11 countries
United States63 sites, 51 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Christopher Page-Goertz
- Recruiting
Albany Medical College
Albany, New York, 12208
518-262-5521
Ilana Harwayne-Gidansky
- Recruiting
Emory University
Atlanta, Georgia, 30322
Pradip Kamat, MD, 404-785-6397, pradip.kamat@choa.org
- Suspended
Children's Hospital of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
- Recruiting
Children's Hospital of Georgia
Augusta, Georgia, 30912
Ashley Freeman
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
John Heldens, 303-724-5000, john.heldens@ucdenver.edu
Rebecca Shay, MD
- Recruiting
Dell Children's Medical Center - Ascension
Austin, Texas, 78723
512-324-0000
Hunter Daigle
- Recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21205
Office of Human Subjects Research IRB, 410-955-3008, jhmeirb@jhmi.edu
Kate Deanehan
- Suspended
University of Maryland
Baltimore, Maryland, 21230
- Recruiting
Children's of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Alabama at Birmingham Institutional Review Board, 205-934-3789, irb@uab.edu
Jordan Newman, MD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Chinyere Egbuta
- Recruiting
Oishei Children's Hospital
Buffalo, New York, 14222
Ryan Breuer, MD, ryankbreuer@gmail.com
- Recruiting
The University of Vermont Children's Hospital
Burlington, Vermont, 05401
Iris Toedt-Pingel, MD, iris.toedt-pingel@uvmhealth.org
- Recruiting
UVA Children's Hospital
Charlottesville, Virginia, 22903
Michelle Adu-Darko, MD, maa7j@hscmail.mcc.virginia.edu
- Recruiting
Northwestern Medicine Prentice Women's Hospital
Chicago, Illinois, 60611
312-926-2000
Nicole Pouppirt
- Recruiting
Cincinnati Hospital Medical Center
Cincinnati, Ohio, 45229
Maya Dewan
- Recruiting
Cleveland Clinic Childrens Hospital
Cleveland, Ohio, 44106
216-444-5437
Sabine Iben
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Anthony Lee, MD, 614-722-3449, Anthony.Lee@nationwidechildrens.org
- Recruiting
Medical City Children's Hospital
Dallas, Texas, 75230
Kris Bysani, MD, KrisBysani@gmail.com
- Recruiting
Duke Children's Hospital
Durham, North Carolina, 27705
Kyle Rehder, MD, 919-681-3550, kyle.rehder@duke.edu
- Recruiting
Children's Hospital - Penn State Hershey
Hershey, Pennsylvania, 17033
Ashley Derbyshire, MD, aderbyshire@hmc.psu.edu
- Recruiting
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Kathleen May, 717-531-5687, khay@hmc.psu.edu
Kristen Glass, MD
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
317-944-5000
Samer Abu-Sultaneh
- Recruiting
Baylor - Christus Children's - Main Hospital
Irving, Texas, 75039
Baylor College of Medicine Office of Research, 713-798-6970, irb@bcm.edu
Megan O'Brien, MD
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Sholeen Nett, MD, 603-650-5000, sholeen.t.nett@hitchcock.org
- Recruiting
Kentucky Children's Hospital
Lexington, Kentucky, 40536
Ashwin Krishna, MD, ashwin.krishna@uky.edu
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Office of Research and Sponsored Programs, 501-686-5667, rcsanders@uams.edu
Ronald C Sanders, MD
- Recruiting
Norton Children's Hospital - University of Louisville
Louisville, Kentucky, 40202
Erin Owen, MD
- Suspended
Children's Hospital of Central California
Madera, California, 93636
- Recruiting
University of Wisconsin - UnityPoint Meriter
Madison, Wisconsin, 53715
Liz Michaels, 608-417-6411, liz.michaels@unitypoint.org
Patrick Peebles
- Recruiting
American Family Children's Hospital - University of Wisconsin
Madison, Wisconsin, 53792
Awni Al-Subu
- Suspended
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
- Suspended
Miami Children's Hospital
Miami, Florida, 33155
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vickren Pillay
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Atlantic Health System, 973-971-5000, anita.richards@atlantichealth.org
Christina Melchionne
- Recruiting
Yale New Haven Children's Hospital
New Haven, Connecticut, 06510
Stephen Latham, JD, PhD, 203-785-4688, human.subjects@yale.edu
Lindsay Johnston, MD
- Recruiting
Yale-New Haven Children's Hospital
New Haven, Connecticut, 06510
John Giuliano, MD, john.giuliano@yale.edu
- Recruiting
Cohen Children's Medical Center
New Hyde Park, New York, 11040
Lily Glater
- Suspended
New York Presbyterian Hospital Weill Cornell Medical College
New York, New York, 10065
- Recruiting
Children's Hospital and Medical Center
Omaha, Nebraska, 68114
Andrea Talukdar
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Elizabeth Foglia
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Philadelphia IRB Office, 215-590-2830, irboffice@chop.edu
Vinay Nadkarni, MD
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85006
PCH IRB, 602-933-1000, swalker@phoenixchildrens.com
David Tellez, MD
- Suspended
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Paula Vanderford, MD, vanderfo@ohsu.edu
- Recruiting
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Lee Polikoff, MD, lee.polikoff@lifespan.org
- Recruiting
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
Mark Piehl
- Recruiting
WakeMed
Raleigh, North Carolina, 27610
Elizabeth Woodard, RN, PhD, 919-350-8795, WakeMed_IRB_Office@wakemed.org
Stephen D DeMeo, DO
- Suspended
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298
- Recruiting
University of Rochester at Golisano Children's Hospital
Rochester, New York, 14642
Adam Dziorny
- Suspended
Gillette Children's Specialty Health
Saint Paul, Minnesota, 55101
- Suspended
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55404
- Recruiting
Baylor - Christus Children's - Westover Hills
San Antonio, Texas, 78251
Baylor College of Medicine Office of Research, 713-798-6970, irb@bcm.edu
Megan O'Brien
- Recruiting
Baylor - Christus Children's - Stone Oak
San Antonio, Texas, 78258
Baylor College of Medicine Office of Research, 713-798-6970, irb@bcm.edu
Megan O'Brien
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Alisyn Franetich, 206-884-2910, alisyn.franetich@seattlechildrens.org
Taylor Sawyer, MD
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Alisyn Franetich, 206-884-2910, alisyn.franetich@seattlechildrens.org
Taylor Sawyer, MD
- Recruiting
University of Wisconsin - American Family Children's Hospital
Shorewood Hills, Wisconsin, 53792
The University of Wisconsin IRB, 608-263-2362, pjpeebles@wisc.edu
Patrick Peebles
- Suspended
Beacon Children's Hospital
South Bend, Indiana, 46601
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
Julien Ginsberg-Peltz
- Recruiting
Stony Brook Children's Hospital
Stony Brook, New York, 11794
Katherine Biagas, MD
- Suspended
The Children's Hospital at Montefiore
The Bronx, New York, 10467
- Recruiting
Maria Fareri Children's Hospital (West Chester Medical)
Valhalla, New York, 10595
Simon Li, MD, 914-493-5941, lis@WCMC.com
- Recruiting
Nemours Children's Health, Delaware
Wilmington, Delaware, 19803
302-651-4200
Kimberly McMahon
Japan7 sites, 6 recruiting
- Recruiting
Hiroshima University
Hiroshima, 734-8551
Nobuaki Shime
- Recruiting
Hyogo Prefectural Kobe Children's Hospital
Kobe, 650-0047
Yuki Nagai
- Recruiting
Aichi Children's Health and Medical Center
Ōbu
Taka Ikeyama, MD
- Recruiting
Saitama Children's Medical Center
Saitama, 350-0451
Takehiro Niitsu
- Recruiting
National Center for Child Health and Development
Setagaya-Ku, Tokyo, 157-8535
+81 3-3416-0181
Masafumi Gima
- Suspended
Jichi Medical University Hospital
Shimotsuke, 329-0431
- Recruiting
Tokyo Metropolitan
Tokyo, 163-8001
Takanari Ikeyama, MD, taqnary@gmail.com
Canada6 sites, 6 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
403-944-1110
Ayman About Mehrem
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A9
Simon Parsons, MD, simon.Parsons@albertahealthservices.ca
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C4
Guillaume Emeriaud, MD, guillaume.emeriaud@umontreal.ca
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, QC H3T 1C5
Ahmed Moussa
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Gordon Krahn, MD, gkrahn@cw.bc.ca
- Recruiting
The University of Manitoba
Winnipeg, B R3T 2N2
(800) 432-1960
Michael Narvey
Australia2 sites, 2 recruiting
- Recruiting
Royal Brisbane and Women's Hospital
Herston, 4006
+61 7 3646 8111
Kate Hodgson
- Recruiting
The Royal Children's Hospital Melbourne
Parkville, 3052
+61 3 9345 5522
David Tingay
India2 sites, 1 recruiting
- Suspended
Rainbow Children's Hospital
Bangalore, 560092
- Recruiting
Aster Hospitals - India
Bengaluru, Karnataka, 560078
+91 80660 40400
Sujatha Thyagarajan
Singapore2 sites, 2 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 168753
Agnes Ng, 65-6225-0488
Quek Bin Huey, MD
- Recruiting
KK Women's & Children's Hospital, Singapore
Singapore, 229899
Jan H Lee, MD, lee.jan.hau@kkh.com.sg
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna (Medizinische Universität Wien)
Vienna, Spitalgasse 23
+43 1 401600
Michael Wagner
Germany1 site
- Suspended
University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital
Lübeck, 23562
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Cardiff & Vale University Health Board
Cardiff, Wales, CF14 4XW
+44 29 2074 7747
Anna Barrow
About this study
Official title: Observation of Multi-center Quality Improvement Project: Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
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.
Read the 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.
- Keywords
- Intubation, Advanced airway intervention, Intensive care unit
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of their hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startMar 2010
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed or Difficult Intubation, SequelaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Vinay Nadkarni, MD. MS, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493478
- Sponsor's protocol ID
- 09-007253
- Other IDs
- R18HS022464
- Acronym
- NEAR4KIDs
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2015
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
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, 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.
PubMed 29406378
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Multi-center Quality Improvement Project: Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
- ClinicalTrials.gov ID
- NCT02493478
- Acronym / sponsor ID
- NEAR4KIDs / 09-007253
- Keywords
- Intubation, Advanced airway intervention, Intensive care unit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2010
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Derived from this study: PubMed 29406378Gabrani 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinay Nadkarni, MD. MS principal investigator
Children's Hospital of Philadelphia
87 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed or Difficult Intubation, Sequela and Intubation; Difficult, run by Children's Hospital of Philadelphia at 87 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Japan, Canada, Australia, India and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayley Buffman, MPH (215-590-6772, buffmanh@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.