Heart Arrest, Out-Of-HospitalPedi-PARTNCT06364280
Pediatric Prehospital Airway Resuscitation Trial
A study testing BVM, SGA and ETI in people with Heart Arrest, Out-Of-Hospital and Wounds and Injuries, run by Ohio State University at 10 sites in United States.
Trial summary
This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Read more about this study
- Who is it for?
- Ages 24 hours to 17 years
- Conditions the study is for
- Heart Arrest, Out-Of-Hospital, Wounds and Injuries, Respiratory Insufficiency in Children
- What is being tested?
- BVM, SGA and ETI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 May 2024to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 hours to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At least 24 hours old and <18 years old
- Cardiopulmonary arrest, major trauma or respiratory failure
- Life-saving care initiated or continued by Pedi-PART EMS personnel as part of an emergency "9-1-1" response
- Requiring active airway management (BVM or higher level of respiratory support
Who cannot join
- Prisoners
- Pre-existing tracheostomy
- Pre-existing do-not-resuscitate/do-not-intubate status
- Visibly or known to be pregnant
- Initial advanced airway attempt by an EMS agency not affiliated with the study
- Interfacility transports
- EMS personnel will use bystander reports or follow local protocols to establish patient age and pregnancy status.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Colordao
Aurora, Colorado, 80045
Dell Medical School, University of Texas at Austin
Austin, Texas, 78712
Mecklenburg County Emergency Medical Services
Charlotte, North Carolina, 28208
Nationwide Children's Hospital
Columbus, Ohio, 43205
Indiana University
Indianapolis, Indiana, 46202
Harbor-University of California Los Angeles Medical Center
Los Angeles, California, 90509
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of California Davis
Sacramento, California, 95817
University of Airzona
Tucson, Arizona, 85721
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: [BVM-only], [BVM followed by SGA] and [BVM followed by ETI]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: [BVM-only] or [BVM followed by SGA]. The [winner of Stage I] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between [BVM followed by ETI] vs. [Winner of Stage I].
Read the detailed description
Cardiac arrest, respiratory failure, and major trauma are devastating critical conditions in children. Resuscitation from critical illness requires skillful airway management to optimize the delivery of oxygen to the lungs, preventing irreparable damage to the brain and heart. As the first to provide resuscitation care for critically ill children, prehospital EMS personnel are often the first to perform life-saving airway management.
The most common prehospital airway management techniques (bag-valve-mask ventilation [BVM], endotracheal intubation [ETI], and supraglottic airway insertion [SGA]) have important trade-offs between risks and benefits. Despite the challenges of ETI and national recommendations favoring BVM, many EMS personnel favor ETI over BVM. Newer SGA devices such as the laryngeal tube (LT), laryngeal mask airway (LMA), and i-gel® have not been compared with other techniques in children. National organizations, including the Agency for Healthcare Research and Quality, have declared the need for new, rigorous trials of all techniques to determine the best strategies for prehospital airway management in children. Interviews with front-line EMS personnel underscore the dire need for clear and strategic guidelines for managing the pediatric airway.
The Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) will determine the best strategies for prehospital airway management in critically ill children. The trial aims are Aim I-Primary Objective (Effectiveness)-Stage I: Determine if [BVM-only] or [BVM followed by SGA] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if [winner of Stage I] or [BVM followed by ETI] results in better ICU-free survival. Bayesian analyses will determine the transition from Stage I to Stage II, ensuring optimal deployment of available subjects to address the postulated questions. Aim 2- Secondary Objective (Safety)-Stage I: Determine if [BVM followed by SGA] results in fewer prehospital and hospital safety events compared with [BVM-only] in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if the winner of Stage I results in fewer safety events compared with [BVM followed by ETI].
The trial will use a Bayesian Adaptive Sequential Comparison Platform Trial (BASiC-PT) design and will be executed in two sequential stages. Stage I: Determine if [BVM-only] or [BVM followed by SGA] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if [winner of Stage I] or [BVM followed by ETI] results in better ICU-free survival. Bayesian analyses will determine the transition from Stage I to Stage II, ensuring optimal deployment of available subjects to address the postulated questions.
- Conditions
- Heart Arrest, Out-Of-Hospital, Wounds and Injuries, Respiratory Insufficiency in Children, Child, Only, Critical Illness
- Being tested
- BVM, SGA, ETI
- Keywords
- airway management, intubation, intratracheal, emergency medical services, children, heart arrest, injuries, respiratory insufficiency
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Wounds and Injuries, Critical Illness, Heart Arrest, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVMDevice
Bag-Valve-Mask Ventilation
SGADevice
Supraglottic Airway
ETIDevice
Endotracheal Intubation
| Study group | Role | What they receive |
|---|---|---|
| BVM-only | Active comparator | Initial strategy of airway management using Bag-Valve-Mask (BVM) only. Receives: Device: BVM |
| BVM followed by SGA [BVM+SGA] | Active comparator | Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA). Receives: Device: BVM; Device: SGA |
| BVM followed by ETI [BVM+ETI] | Active comparator | Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI). Receives: Device: BVM; Device: ETI |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day ICU-free survival
The number of days in the first 30 days after the treatment event where: 1) the patient was not known to have died; and 2) the patient was not hospitalized in the intensive care unit. ICU admission/discharge criteria will not be standardized.
Measured: 30 days
Secondary outcomes (1)
Neurologic outcome upon hospital discharge
Outcome will be measured with Pediatric Cerebral Performance Category score (PCPC - 1 = normal, 2 = mild disability, 3 = moderate disability, 4 = severe disability, 5 = coma or vegetative state, 6 = dead).
Measured: Identified through end of study but no later than 30 days after final enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start20 May 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Why it stopped: Enrollment in Stage I paused due to operational futility.
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 Heart Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The trial uses a Bayesian Adaptive Sequential Platform Trial (BASIC-PT) framework. The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\]. The interventions will be quasi-randomized using alternate day assignment.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Wang, MD, Ohio State University
- Investigators
- Henry E Wang, MD, MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364280
- Sponsor's protocol ID
- 2023X0135
- Other IDs
- UG3HL165019, U24HL165014, UH3HL165019, R01HL181356
- Acronym
- Pedi-PART
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bosson N, Hansen M, Gausche-Hill M, Lewis RJ, Wendelberger B, Shah MI, VanBuren JM, Wang HE. Design of a novel clinical trial of prehospital pediatric airway management. Clin Trials. 2022 Feb;19(1):62-70. doi: 10.1177/17407745211059855. Epub 2021 Dec 7.
PubMed 34875893
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Prehospital Airway Resuscitation Trial
- ClinicalTrials.gov ID
- NCT06364280
- Acronym / sponsor ID
- Pedi-PART / 2023X0135
- Conditions
- Heart Arrest, Out-Of-Hospital, Wounds and Injuries, Respiratory Insufficiency in Children, Child, Only, Critical Illness
- Keywords
- airway management, intubation, intratracheal, emergency medical services, children, heart arrest, injuries, respiratory insufficiency
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment in Stage I paused due to operational futility.
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Utah
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 15 Apr 2024 (actual)
- 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.
This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: [BVM-only], [BVM followed by SGA] and [BVM followed by ETI]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: [BVM-only] or [BVM followed by SGA]. The [winner of Stage I] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between [BVM followed by ETI] vs. [Winner of Stage I].
Detailed description
Cardiac arrest, respiratory failure, and major trauma are devastating critical conditions in children. Resuscitation from critical illness requires skillful airway management to optimize the delivery of oxygen to the lungs, preventing irreparable damage to the brain and heart. As the first to provide resuscitation care for critically ill children, prehospital EMS personnel are often the first to perform life-saving airway management.
The most common prehospital airway management techniques (bag-valve-mask ventilation [BVM], endotracheal intubation [ETI], and supraglottic airway insertion [SGA]) have important trade-offs between risks and benefits. Despite the challenges of ETI and national recommendations favoring BVM, many EMS personnel favor ETI over BVM. Newer SGA devices such as the laryngeal tube (LT), laryngeal mask airway (LMA), and i-gel® have not been compared with other techniques in children. National organizations, including the Agency for Healthcare Research and Quality, have declared the need for new, rigorous trials of all techniques to determine the best strategies for prehospital airway management in children. Interviews with front-line EMS personnel underscore the dire need for clear and strategic guidelines for managing the pediatric airway.
The Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) will determine the best strategies for prehospital airway management in critically ill children. The trial aims are Aim I-Primary Objective (Effectiveness)-Stage I: Determine if [BVM-only] or [BVM followed by SGA] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if [winner of Stage I] or [BVM followed by ETI] results in better ICU-free survival. Bayesian analyses will determine the transition from Stage I to Stage II, ensuring optimal deployment of available subjects to address the postulated questions. Aim 2- Secondary Objective (Safety)-Stage I: Determine if [BVM followed by SGA] results in fewer prehospital and hospital safety events compared with [BVM-only] in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if the winner of Stage I results in fewer safety events compared with [BVM followed by ETI].
The trial will use a Bayesian Adaptive Sequential Comparison Platform Trial (BASiC-PT) design and will be executed in two sequential stages. Stage I: Determine if [BVM-only] or [BVM followed by SGA] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if [winner of Stage I] or [BVM followed by ETI] results in better ICU-free survival. Bayesian analyses will determine the transition from Stage I to Stage II, ensuring optimal deployment of available subjects to address the postulated questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The trial uses a Bayesian Adaptive Sequential Platform Trial (BASIC-PT) framework. The study interventions are strategies of prehospital airway management: [BVM-only], [BVM followed by SGA] and [BVM followed by ETI]. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: [BVM-only] or [BVM followed by SGA]. The [winner of Stage I] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between [BVM followed by ETI] vs. [Winner of Stage I]. The interventions will be quasi-randomized using alternate day assignment.
| Arm | Type | Receives |
|---|---|---|
| BVM-only | Active comparator | Device: BVMInitial strategy of airway management using Bag-Valve-Mask (BVM) only. |
| BVM followed by SGA [BVM+SGA] | Active comparator | Device: BVM, Device: SGAInitial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA). |
| BVM followed by ETI [BVM+ETI] | Active comparator | Device: BVM, Device: ETIInitial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI). |
Who may qualify
- Ages
- 24 hours to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- At least 24 hours old and <18 years old
- Cardiopulmonary arrest, major trauma or respiratory failure
- Life-saving care initiated or continued by Pedi-PART EMS personnel as part of an emergency "9-1-1" response
- Requiring active airway management (BVM or higher level of respiratory support
Key exclusion criteria (7 listed)
- Prisoners
- Pre-existing tracheostomy
- Pre-existing do-not-resuscitate/do-not-intubate status
- Visibly or known to be pregnant
- Initial advanced airway attempt by an EMS agency not affiliated with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVMBag-Valve-Mask Ventilation | Device | BVM followed by ETI [BVM+ETI], BVM followed by SGA [BVM+SGA], BVM-only |
| SGASupraglottic Airway | Device | BVM followed by SGA [BVM+SGA] |
| ETIEndotracheal Intubation | Device | BVM followed by ETI [BVM+ETI] |
Primary outcome
30-day ICU-free survival
Time frame: 30 days
The number of days in the first 30 days after the treatment event where: 1) the patient was not known to have died; and 2) the patient was not hospitalized in the intensive care unit. ICU admission/discharge criteria will not be standardized.
1 secondary outcome
Neurologic outcome upon hospital discharge
Time frame: Identified through end of study but no later than 30 days after final enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 34875893Bosson N, Hansen M, Gausche-Hill M, Lewis RJ, Wendelberger B, Shah MI, VanBuren JM, Wang HE. Design of a novel clinical trial of prehospital pediatric airway management. Clin Trials. 2022 Feb;19(1):62-70. doi: 10.1177/17407745211059855. Epub 2021 Dec 7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Henry E Wang, MD, MS principal investigator
Ohio State University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BVM, SGA and ETI in people with Heart Arrest, Out-Of-Hospital and Wounds and Injuries, run by Ohio State University at 10 sites in United States.
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 4 inclusion and 7 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: paused, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day ICU-free survival (time frame: 30 days). 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 NCT06364280, 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 7 Apr 2026.