Airway Management for Critically Ill Children

(Pedi-PART Trial)

Recruiting at 9 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 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. \[Winner of Stage I\].

Will I have to stop taking my current medications?

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

Is airway management generally safe for critically ill children?

Research on pediatric airway management, including prehospital intubation, shows that it can be complex and sometimes controversial due to varying success rates and potential adverse events. However, when performed by trained professionals, it is considered a critical part of emergency care for critically ill children. ^{1 2 3 4 5}

How is Prehospital Airway Resuscitation different from other treatments for critically ill children?

Prehospital Airway Resuscitation is unique because it focuses on managing the airway of critically ill children before they reach the hospital, often involving advanced techniques like endotracheal intubation (inserting a tube into the windpipe to help with breathing). This approach is controversial due to varying success rates and the complexity of performing such procedures outside of a hospital setting. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Prehospital Airway Resuscitation for critically ill children?

Research shows that prehospital airway management, including advanced techniques like endotracheal intubation (inserting a tube into the windpipe), is crucial for critically ill children, but its success and safety can vary. Some studies suggest that using alternative devices like extraglottic airways (devices placed above the vocal cords) may improve outcomes in emergency situations. ^{2 5 6 9 10}

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

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 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]

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 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]

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]

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 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]

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]

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]

Citations

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Early Versus Late Advanced Airway Management for Pediatric Patients With Out-of-Hospital Cardiac Arrest. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Paediatric airway management and concerns: a survey of advanced paramedics in Ireland. [2020]

4. England 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of an Extraglottic Device on Pediatric Airway Management in an Urban Prehospital System. [2020]

6. United States 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. [2018]

7. Ireland pubmed.ncbi.nlm.nih.gov

Airway management in pediatric patients at referring hospitals compared to a receiving tertiary pediatric ICU. [2011]

8. Ireland pubmed.ncbi.nlm.nih.gov

Characteristics and outcome of prehospital paediatric tracheal intubation attended by anaesthesia-trained emergency physicians. [2010]

9. Ireland pubmed.ncbi.nlm.nih.gov

Epidemiology of out-of-hospital pediatric airway management in the 2019 national emergency medical services information system data set. [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

[Rapid airway access]. [2020]