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Procedure

Airway Management for Critically Ill Children (Pedi-PART Trial)

N/A
Recruiting
Led By Henry E Wang, MD, MS
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requiring active airway management (BVM or higher level of respiratory support)
Experiencing cardiopulmonary arrest, major trauma, or respiratory failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing different ways to help critically ill children breathe better before they reach the hospital. They are comparing three methods: using a bag valve mask only, using a bag valve mask followed by a

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include complications related to incorrect tube placement, aspiration pneumonia due to vomiting with compromised airways, injury to teeth or soft tissues during intubation, and hyperventilation or hypoventilation from improper use of BVM.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need help with breathing, such as a bag valve mask or more advanced support.
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I am currently experiencing a severe heart or lung emergency.
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I am younger than 18 years old.
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I received emergency life-saving care from Pedi-PART EMS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
30-day ICU-free survival
Secondary study objectives
Neurologic outcome upon hospital discharge

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: BVM followed by SGA [BVM+SGA]Active Control2 Interventions
Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA).
Group II: BVM-onlyActive Control1 Intervention
Initial strategy of airway management using Bag-Valve-Mask (BVM) only.
Group III: BVM followed by ETI [BVM+ETI]Active Control2 Interventions
Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI).

Find a Location

Who is running the clinical trial?

University of UtahOTHER
1,139 Previous Clinical Trials
1,694,360 Total Patients Enrolled
Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
652,157 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,928 Previous Clinical Trials
47,762,173 Total Patients Enrolled
~2000 spots leftby Aug 2029
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