Airway Management for Critically Ill Children

(Pedi-PART Trial)

Recruiting at 10 trial locations

Overseen By Jennifer Frey, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Prisoners, Tracheostomy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

3000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to help critically ill children breathe better during emergencies. Researchers are testing different strategies for EMS crews, such as using a bag-valve-mask (BVM), adding a supraglottic airway (SGA), or attempting endotracheal intubation (ETI) after BVM. The goal is to determine which method helps children survive without needing intensive care for 30 days. Children who have experienced a severe accident, heart or breathing failure, and require emergency care might be suitable for this study. Known as Prehospital Airway Resuscitation, or Pedi-PART, this study focuses on advanced airway management techniques. As an unphased trial, it offers a unique opportunity to contribute to life-saving research that could improve emergency care for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these airway management strategies are safe for critically ill children?

Research has shown that various methods of assisting critically ill children with breathing are generally safe. For instance, emergency medical services (EMS) commonly and safely use a Bag-Valve-Mask (BVM) to help children breathe. Studies have found that following BVM with a Supraglottic Airway (SGA) is usually safe and effective.

Endotracheal Intubation (ETI), which involves placing a tube into the windpipe, is also widely used in emergencies. Although more invasive than other methods, trained EMS personnel routinely perform it. When done correctly, ETI is generally safe, though it may carry risks like discomfort or minor injury, which are usually manageable.

These methods have been trusted by professionals in critical situations for years. The trial aims to determine which method works best, but all are recognized as safe options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different airway management strategies for critically ill children, a crucial aspect of emergency care. Unlike traditional methods that might rely heavily on endotracheal intubation (ETI) from the start, this trial examines the effectiveness of using a Bag-Valve-Mask (BVM) first, followed by a Supraglottic Airway (SGA) or ETI. The BVM-only approach is also being studied to see if it offers comparable outcomes with less invasiveness. By comparing these methods, the trial aims to find the most effective and least invasive technique for managing airways in emergency situations, potentially improving outcomes and reducing complications for young patients.

What evidence suggests that this trial's airway management strategies could be effective for critically ill children?

This trial will compare different airway management strategies for critically ill children. Studies have shown that providing breathing support to critically ill children before they reach the hospital is crucial for their survival. In this trial, one group will use a Bag-Valve-Mask (BVM) only, while another group will use BVM followed by a Supraglottic Airway (SGA), a device placed above the voice box to secure breathing. A third group will use BVM followed by Endotracheal Intubation (ETI), which involves placing a tube directly into the windpipe. Both these additions aim to enhance breathing support compared to using a BVM alone. Initial findings suggest that selecting the optimal method can improve survival rates and reduce time in intensive care for children. ^{1 2 3 5 6}

Who Is on the Research Team?

Henry E Wang, MD, MS

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for children under 18 who've had a cardiac arrest, major trauma, or respiratory failure and need emergency airway management. They must be at least 24 hours old and receive care from Pedi-PART EMS as part of an emergency response.

Inclusion Criteria

I need help with breathing, such as a bag valve mask or more advanced support.

I am currently experiencing a severe heart or lung emergency.

I received emergency life-saving care from Pedi-PART EMS.

Exclusion Criteria

Pre-existing tracheostomy

Pre-existing do-not-resuscitate/do-not-intubate status

Visibly or known to be pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage I Treatment

EMS personnel alternate between BVM-only or BVM followed by SGA to determine better ICU-free survival

Duration not specified

Stage II Treatment

EMS personnel alternate between the winner of Stage I and BVM followed by ETI to determine better ICU-free survival

Duration not specified

Follow-up

Participants are monitored for ICU-free survival and neurologic outcomes up to 30 days after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Prehospital Airway Resuscitation

Trial Overview The study compares prehospital airway management strategies in critically ill children: BVM-only, BVM followed by SGA (supraglottic airway), and BVM followed by ETI (endotracheal intubation). It's to see which method helps more kids stay out of the ICU after 30 days.

How Is the Trial Designed?

Group I: BVM followed by SGA [BVM+SGA] Active Control 2 Interventions

Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA).

Group II: BVM-only Active Control 1 Intervention

Initial strategy of airway management using Bag-Valve-Mask (BVM) only.

Group III: BVM followed by ETI [BVM+ETI] Active Control 2 Interventions

Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI).

Prehospital Airway Resuscitation is already approved in United States for the following indications:

Approved in United States as Prehospital Airway Resuscitation for:

• Cardiopulmonary arrest
• Major trauma
• Respiratory failure

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A national survey of 492 prehospital professionals revealed that a lack of experience with pediatric airway management is a significant contributor to patient safety events, particularly in advanced airway interventions.

Endotracheal intubation was identified as the top technical skill associated with safety events, highlighting the need for improved training and decision-making processes in prehospital pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Airway Management and Prehospital Patient Safety: Results of a National Delphi Survey by the Children's Safety Initiative-Emergency Medical Services for Children. Hansen, M., Meckler, G., OʼBrien, K., et al.[2018]

In a study of 253 critical care transports over 3 years, adverse events related to tracheal intubation (TIAEs) occurred in 19% of cases, with the most common issue being mainstem bronchial intubation, but this rate was similar to that seen in a pediatric ICU (PICU).

The majority of patients under 8 years old were intubated with uncuffed tracheal tubes (63%), which is significantly higher than the 20% usage in the PICU, and only two patients required a change from uncuffed to cuffed tubes due to air leaks, indicating a generally safe practice in airway management during transport.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway management in pediatric patients at referring hospitals compared to a receiving tertiary pediatric ICU. Nishisaki, A., Marwaha, N., Kasinathan, V., et al.[2011]

In a study of 425 pediatric patients treated by a Swiss Air-Ambulance crew, the first attempt at endotracheal intubation was successful in 95.3% of cases, indicating a high efficacy in pre-hospital airway management.

However, there was a significant issue with endotracheal tube sizing, as 14.6% of patients had tubes that were too large, particularly in children under 1 year old, and 38.9% of tubes were inserted deeper than recommended, highlighting the need for improved guidelines to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ease and difficulty of pre-hospital airway management in 425 paediatric patients treated by a helicopter emergency medical service: a retrospective analysis. Schmidt, AR., Ulrich, L., Seifert, B., et al.[2018]

A survey of 382 Irish Advanced Paramedics revealed that while 70% had encountered children needing airway management in the past year, only a small number had attempted endotracheal intubation, indicating limited practical experience.

The study highlights concerns about the lack of training and practice in paediatric intubation among paramedics, suggesting that the risks associated with pre-hospital paediatric intubation may not be justified given the infrequent exposure to such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatric airway management and concerns: a survey of advanced paramedics in Ireland. Coleman, N., Barry, T., Tobin, H., et al.[2020]

In a review of 260 pediatric intubations performed by air-transport providers, the first-pass intubation success rate was 78.6%, with an overall success rate of 95.7%, indicating that prehospital intubation can be highly effective in critically ill children.

The study found no significant differences in intubation success rates between medical and trauma cases, nor across different age groups, suggesting that the technique is consistently effective regardless of the patient's condition or age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two hundred sixty pediatric emergency airway encounters by air transport personnel: a report of the air transport emergency airway management (NEAR VI: "A-TEAM") project. Tollefsen, WW., Brown, CA., Cox, KL., et al.[2022]

In a study of over 1.1 million pediatric emergency medical service encounters, airway management interventions were performed in 22,637 cases, highlighting that bag-valve-mask ventilation (BVM) is the most common technique used in prehospital settings.

Tracheal intubation (TI) had a success rate of 75.2%, with the lowest success observed in infants aged 0-1 month (56.8%), indicating that age significantly impacts the effectiveness of airway management techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of out-of-hospital pediatric airway management in the 2019 national emergency medical services information system data set. Hanlin, ER., Chan, HK., Hansen, M., et al.[2022]

In a study of 667 pediatric patients who experienced out-of-hospital cardiac arrest, the timing of advanced airway management (early vs. late) did not significantly impact survival rates or favorable neurological outcomes after one month.

Both early (within 20 minutes) and late (after 20 minutes) advanced airway management showed similar results in terms of patient outcomes, suggesting that the timing of intervention may not be as critical as previously thought, although further randomized controlled trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Versus Late Advanced Airway Management for Pediatric Patients With Out-of-Hospital Cardiac Arrest. Amagasa, S., Iwamoto, S., Kashiura, M., et al.[2023]

In an 8-year study involving 2040 children, emergency physicians achieved a high success rate of 98.3% for prehospital tracheal intubation, particularly among those trained in anesthesia, with 82 children intubated overall.

The study found that 86.6% of the intubated children survived to hospital admission, and 76.8% survived to discharge, with 85.7% of survivors showing favorable neurological outcomes, although infants had poorer outcomes compared to older children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and outcome of prehospital paediatric tracheal intubation attended by anaesthesia-trained emergency physicians. Eich, C., Roessler, M., Nemeth, M., et al.[2010]

Safe airway management in critically ill children relies on trained professionals and the use of rapid sequence intubation, which involves careful preparation, sedation, and neuromuscular blocking agents.

The study emphasizes that there is no one-size-fits-all intubation protocol; the choice of procedure must be tailored to the specific needs and conditions of each patient, highlighting the importance of training and knowledge in pediatric airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rapid airway access]. Amantéa, SL., Piva, JP., Zanella, MI., et al.[2020]

The introduction of a pediatric airway management protocol that included extraglottic airways (EGA) led to a significant reduction in prehospital intubation attempts from 79.6% to 44.7% in children with respiratory failure or cardiac arrest, suggesting a shift in practice towards using EGAs.

While the success rate of intubation decreased from 81.4% to 63.6% after the protocol change, the EGA showed a high success rate of 95.4%, indicating that EGAs may be a more effective alternative for airway management in pediatric emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Extraglottic Device on Pediatric Airway Management in an Urban Prehospital System. Ostermayer, DG., Camp, EA., Langabeer, JR., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06364280

Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management ...

2. medicine.iu.edu medicine.iu.edu/emergency-medicine/research/clinical/pediatric-prehospital-airway-resuscitation

Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) The Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) will determine the best strategies for prehospital airway management in critically ill children ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12499907/

Contemporary issues in pediatric prehospital airway ... As in adults, prehospital airway management in children is important for facilitating oxygen delivery during resuscitation from critical illness ...

4. ohiostate.elsevierpure.com ohiostate.elsevierpure.com/en/projects/12-pediatric-prehospital-airway-resuscitation-trial-2

1/2 – Pediatric Prehospital Airway Resuscitation Trial We propose the novel Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) to determine the best strategies for prehospital airway management in ...

5. ctv.veeva.com ctv.veeva.com/study/pediatric-prehospital-airway-resuscitation-trial

Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway ...

6. nationwidechildrens.org nationwidechildrens.org/research/clinical-research/emergency-services-clinical-research/pedi-part-study

Pedi-PART Study for Pediatric Emergencies The Pedi-PART study will determine which of the three airway management methods is best when caring for children who are critically ill and need emergency care.