First responder airway and compression rate cluster randomized controlled trial: rational and design.
Thomas Rea, Jenny Shin, Jennifer Blackwood...
https://pubmed.ncbi.nlm.nih.gov/42005615/Actively Recruiting
Led by University of Washington · Updated on 2024-06-13
4200
Participants Needed
1
Research Sites
12 weeks
Total Duration
Researchers are evaluating basic life support treatments given by Emergency Medical Services EMS first responders to adults who experience sudden out-of-hospital cardiac arrest SCA. The trial compares two rescue breathing methods the standard Bag Valve Mask BVM and the i-gel device. It also studies different chest compression rates during CPR within the recommended range of 100 to 120 compressions per minute. Both treatments are currently used in standard care, and the study aims to see which approach may improve survival to hospital discharge. Participants will be treated by one of 28 EMS agencies randomly assigned to use either the BVM or the i-gel for airway management. These agencies will also be assigned to provide chest compressions at a set rate of either 100, 110, or 120 compressions per minute, guided by a metronome. The study compares these standard-of-care techniques to better understand their effects on patient outcomes. During the study, researchers will track participants from the time of cardiac arrest through hospital discharge, monitoring survival and neurological function. They will observe return of spontaneous circulation shortly after the event and follow survival and neurological status for up to six months. Data on chest compression rates will be electronically recorded to ensure adherence. The total duration of participation varies depending on hospital stay and recovery.
CONDITIONS
First Responder Airway & Compression Rate Trial
J
Jenny B Shin
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University of Washington
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | i-gel airway with metronome‑guided compression rate | Bag‑valve‑mask ventilation with non‑guided guideline‑range compression rate | Guideline care: BVM + 100‑120 compressions/min |
|---|---|---|---|
| What this option entails | Use of the i‑gel supraglottic airway device with chest compression rate guided by a metronome under controlled assignment | Bag‑valve‑mask ventilation with compression rate assigned within the guideline‑specified range, without metronome guidance | Bag‑valve‑mask ventilation with rescue compression at 100‑120 compressions per minute as current guideline‑recommended practice |
| Role in the trial | One of the investigational first responder strategies under randomization | Comparator strategy within the randomized factorial design | Reflects usual airway and compression practice recommended in current resuscitation guidelines |
| Primary purpose | To assess whether i‑gel airway and controlled compression rate improve survival outcomes | To serve as internal control with standard airway and variable compression rate | Appears in practice to deliver guideline‑recommended airway and compression care |
| How it is performed | First responders use i‑gel for ventilation and follow assigned compression rate using a metronome | Ventilation via bag‑valve‑mask and chest compressions delivered according to EMS performance variability within guideline range | Ventilation with bag‑valve‑mask and compressions performed at 100‑120 compressions per minute as a clinical guideline standard |
| Evidence maturity | Evidence pending; trial is ongoing without posted results | Standard method within the trial; no published results yet | Supported by established resuscitation guidelines based on broader CPR evidence |
| Important limitations | No results yet; trial outcomes not yet available | Same as investigational arm; effectiveness unknown until trial completion | Guideline‑based care may not match trial conditions exactly and lacks trial validation in this factorial design |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of resuscitation attempt during emergency response
Participants receive one of two standard rescue breathing methods (BVM or i-gel) along with chest compressions at a randomized rate of 100, 110, or 120 compressions per minute during CPR administered by EMS first responders.
Emergency treatment by first responders at the time of cardiac arrest
Duration - Up to 6 months
Participants are monitored for survival and neurological outcomes up to 6 months after the cardiac arrest event.
Approximately 1 to 2 follow-up assessments after hospital discharge
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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Thomas Rea, Jenny Shin, Jennifer Blackwood...
https://pubmed.ncbi.nlm.nih.gov/42005615/University of Washington
Lead Sponsor