Airway & Compression Techniques for Cardiac Arrest

(FACT Trial)

Overseen By Jenny B Shin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Advanced life support, Pregnancy, Pediatrics, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate intervention during cardiac arrest event

4200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The First responder Airway \& Compression rate Trial (FACT) Study will address basic life support (BLS) treatments administered by Emergency Medical Services (EMS) first responders to patients who suffer a sudden circulatory (pulseless) collapse, referred to as sudden out-of-hospital cardiac arrest (SCA). The investigators propose a randomized controlled trial among persons who suffer SCA to compare these two rescue breathing approaches (standard Bag Valve Mask vs i-gel) along with evaluating a more precise chest compression rate within the range of 100-120 compressions per minute during CPR. Importantly, each of these treatments fall within established resuscitation guidelines and are already administered as part of standard care in clinical practice. Thus this proposed trial will essentially be comparing one standard-of-care treatment against another standard-of-care treatment. The study will address two primary aims: Aim 1: To compare survival to hospital discharge between SCA patients randomized to BVM versus the i-gel for rescue breathing. The hypothesis is that treatment with i-gel will result in a higher rate of survival to hospital discharge than BVM. Aim 2: To compare survival to hospital discharge between SCA patients randomized to chest compression rates of 100 versus 110 versus 120 per minute. The hypothesis is that treatment with 100 chest compressions per minute will result in a higher rate of survival to hospital discharge than compression rates of 110 or 120 per minute.

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 the airway and compression technique for cardiac arrest safe for humans?

The research articles focus on the quality and effectiveness of chest compressions and airway devices during CPR, but they do not provide specific safety data for humans. ^{1 2 3 4 5}

How does the treatment using Compression Rate and i-gel differ from other treatments for cardiac arrest?

The treatment using Compression Rate and i-gel is unique because it focuses on optimizing the rate of chest compressions during CPR and uses the i-gel airway device, which is a simple, non-inflatable mask that provides a clear airway quickly and effectively, potentially improving outcomes during cardiac arrest compared to traditional methods. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Airway & Compression Techniques for Cardiac Arrest?

Research shows that the i-gel, a device used to keep the airway open, is easier and faster to insert during CPR, which can help maintain effective chest compressions. Additionally, studies suggest that chest compression rates of 100-120 per minute are recommended, but higher rates may increase blood flow, potentially improving outcomes during cardiac arrest. ^{11 12 13 14 15}

Who Is on the Research Team?

Thomas Rea, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults in Seattle and greater King County who experience a sudden, non-traumatic cardiac arrest outside of the hospital where EMS will attempt resuscitation.

Inclusion Criteria

Adults suffering out-of-hospital non-traumatic SCA in Seattle and greater King County in whom resuscitation will be attempted by first responding EMS personnel.

Exclusion Criteria

Other protected populations (pediatrics)

Known prisoner

Known pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive basic life support treatments including rescue breathing with either BVM or i-gel and chest compressions at varying rates

Immediate intervention during cardiac arrest event

Follow-up

Participants are monitored for survival to hospital discharge and neurological function

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Compression Rate
• i-gel

Trial Overview The FACT Study compares two rescue breathing methods (standard Bag Valve Mask vs i-gel) and three chest compression rates (100, 110, or 120 per minute) during CPR to see which leads to better survival rates after cardiac arrest.

How Is the Trial Designed?

Group I: Compression Rate Active Control 1 Intervention

Each of 28 first responder EMS agencies in King County will be randomly assigned with one of the three chest compression rates (100 vs 110 vs 120) at the outset.

Group II: Airway Strategy Active Control 1 Intervention

Each of 28 first responder EMS agencies in King County will be randomly assigned to treat with either the BVM or i-gel for airway strategy

Compression Rate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Chest Compression Rate for:

• Cardiac arrest
• Sudden circulatory collapse

Approved in European Union as Cardiopulmonary Resuscitation (CPR) Rate for:

• Out-of-hospital cardiac arrest
• Cardiac emergency

Approved in Canada as Chest Compression Rate for:

• Sudden cardiac arrest
• Cardiopulmonary emergency

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

The i-gel™ supraglottic airway device demonstrated a high first-attempt insertion success rate of 90% among paramedics and emergency physicians during CPR, indicating it is easy to use in emergency situations.

Ventilation was adequate in 96% of CPR attempts, and the i-gel™ allowed for continuous chest compressions without interruptions in 74% of cases, supporting its effectiveness in maintaining ventilation while minimizing pauses in chest compressions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the i-gel™ during pre-hospital cardiopulmonary resuscitation. Häske, D., Schempf, B., Gaier, G., et al.[2019]

The i-gel has a higher success rate for airway management in cardiac arrest patients (94% and 92%) compared to endotracheal tube insertion (90% and 86%), making it a preferred choice for prehospital resuscitation.

The use of i-gel is increasing among emergency staff, as it allows for faster insertion and enables quicker progression to other resuscitation efforts, although some staff still prefer ET tubes due to confidence issues with new equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction of the I-gel supraglottic airway device for prehospital airway management in a UK ambulance service. Duckett, J., Fell, P., Han, K., et al.[2016]

Nursing staff can successfully use the I-gel and the intubating laryngeal mask Fastrach (ILMA) for airway management during cardiopulmonary resuscitation, demonstrating comparable success rates in a mannequin study with 45 participants.

The ILMA was found to be more successful than the I-gel in securing the airway, although both devices experienced longer intubation times when chest compressions were ongoing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of blind intubation through the I-gel and ILMA Fastrach by nurses during cardiopulmonary resuscitation: a manikin study. Melissopoulou, T., Stroumpoulis, K., Sampanis, MA., et al.[2018]

In a study of 222 adult patients experiencing in-hospital cardiac arrest, a chest compression rate of 121-140 compressions per minute was associated with the highest likelihood of achieving return of spontaneous circulation (ROSC), with an odds ratio of 4.48.

The findings suggest that increasing the chest compression rate above the current guideline recommendation of 100-120 compressions per minute may improve outcomes in cardiac arrest situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between chest compression rates and clinical outcomes following in-hospital cardiac arrest at an academic tertiary hospital. Kilgannon, JH., Kirchhoff, M., Pierce, L., et al.[2022]

The i-gel is easier and faster to insert than traditional laryngeal mask airways during general anesthesia, as it does not require cuff inflation, which could enhance its use in emergency situations.

A new tailored device for cardiopulmonary resuscitation that includes the i-gel O2 and additional tools may improve airway management during emergencies, addressing previous challenges with securing the i-gel in place.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of the i-gel in emergency airway management]. Ueshima, H., Asai, T.[2014]

In a study involving 20 healthcare professionals, faster chest compression rates (160 min(-1)) led to more compressions and a higher duty-cycle but significantly reduced compression depth and quality over time.

The optimal compression rate for maintaining quality during CPR is between 100-120 min(-1), as rates above this can compromise the effectiveness of compressions, highlighting the need for further research on updated guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of chest compression rates on quality of chest compressions - a manikin study. Field, RA., Soar, J., Davies, RP., et al.[2022]

The Radarcirc ECG demonstrated significantly better accuracy in detecting ventricular fibrillation during CPR compared to the conventional ECG, with an area under the curve (AUC) of 0.987 for lead I, indicating its potential for improved clinical outcomes.

In a study involving 41 out-of-hospital cardiac arrest patients, the Radarcirc ECG provided more reliable rhythm assessments during chest compressions, suggesting it could enhance the effectiveness of CPR by minimizing diagnostic errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of a new multifunctional electrocardiograph during uninterrupted chest compressions in cardiac arrest patients. Shimpuku, G., Morimura, N., Sakamoto, T., et al.[2019]

The effective compression ratio (ECR) is a new parameter that combines multiple aspects of CPR quality, such as compression depth and hand position, allowing for a quick assessment of chest compression effectiveness.

The ECR can be easily integrated into existing CPR feedback systems and is adaptable to various guidelines, making it a valuable tool for improving CPR training and performance evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective compression ratio--a new measurement of the quality of thorax compression during CPR. Greif, R., Stumpf, D., Neuhold, S., et al.[2013]

In a study of 410 patients who experienced cardiopulmonary arrest, the use of ultrasonography (USG) during CPR helped detect cardiac activity, which is crucial for assessing the effectiveness of resuscitation efforts.

Patients with ventricular fibrillation/pulseless ventricular tachycardia (VF/pVT) and pulseless electrical activity (PEA) had significantly higher 24-hour survival rates compared to those in asystole, highlighting the importance of identifying cardiac activity during CPR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of cardiac sonography for estimating the early term survival of the cardiopulmonary arrest patients. Cebicci, H., Salt, O., Gurbuz, S., et al.[2021]

In a study involving 40 emergency medical technicians, the use of supraglottic airway devices (like the laryngeal tube and Combitube) resulted in significantly shorter hands-off times during CPR compared to the conventional endotracheal tube, which had a hands-off time of 48 seconds.

All technicians successfully used supraglottic devices, while only a third were able to successfully insert an endotracheal tube, suggesting that supraglottic devices are a safer and more effective option for emergency airway management, especially for those with limited experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hands-off time during insertion of six airway devices during cardiopulmonary resuscitation: a randomised manikin trial. Ruetzler, K., Gruber, C., Nabecker, S., et al.[2011]

The double-balloon technique for embolization of carotid cavernous fistulas (CCFs) successfully treated 9 out of 11 cases where the conventional single-balloon method failed, demonstrating its efficacy in challenging situations.

This technique allows for the treatment of CCFs while preserving the parent internal carotid artery, reducing the need for sacrificing the artery, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-balloon technique for embolization of carotid cavernous fistulas. Teng, MM., Chang, CY., Chiang, JH., et al.[2021]

A new carbonized cellulose-based aerogel has been developed to effectively manage noncompressible torso hemorrhage, showing superior hemostatic ability in both small and large animal models compared to existing treatments.

The aerogel's effectiveness is attributed to its high blood absorption, hemoglobin binding efficiency, and ability to activate platelets, making it a promising solution for preventing death from uncontrolled bleeding in trauma situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Super-Elastic Carbonized Mushroom Aerogel for Management of Uncontrolled Hemorrhage. Yang, G., Huang, Z., McCarthy, A., et al.[2023]

Manual compression of the common carotid artery (CCA) during coil embolization can effectively manage intraprocedural rupture (IPR) of a ruptured intracranial aneurysm.

Simultaneous detection of IPR and immediate intervention with CCA compression and aneurysm coiling may improve clinical outcomes, suggesting a potentially safe and effective approach in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraprocedural rupture management for intracranial aneurysm rupture during coil embolization by manual common carotid artery compression. Chang, CH., Jung, YJ., Kim, JH.[2019]

The balloon-tipped intra-arterial catheter technique for occluding carotid-cavernous fistulas has been reported as a simple and highly effective procedure.

In a study involving two patients, this method successfully treated the fistulas without any reported complications, indicating its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of carotid-cavernous fistula using a balloon-tipped intra-arterial catheter. Chowdhary, UM.[2019]

Manual carotid compression is an effective treatment for spontaneous carotid-cavernous sinus fistulas, as demonstrated in a case involving a 63-year-old woman who underwent the procedure for 10 days.

However, this treatment can lead to neurological complications, such as injury to the brachial plexus and supraclavicular nerve, which resolved within a month after stopping the procedure, highlighting the need for awareness of potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brachial plexus and supraclavicular nerve injury caused by manual carotid compression for spontaneous carotid-cavernous sinus fistula. Komiyama, M., Nakajima, H., Nishikawa, M., et al.[2019]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Performance of the i-gel™ during pre-hospital cardiopulmonary resuscitation. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Introduction of the I-gel supraglottic airway device for prehospital airway management in a UK ambulance service. [2016]

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

Comparison of blind intubation through the I-gel and ILMA Fastrach by nurses during cardiopulmonary resuscitation: a manikin study. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Association between chest compression rates and clinical outcomes following in-hospital cardiac arrest at an academic tertiary hospital. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

[Role of the i-gel in emergency airway management]. [2014]

6. Ireland pubmed.ncbi.nlm.nih.gov

The impact of chest compression rates on quality of chest compressions - a manikin study. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

Diagnostic performance of a new multifunctional electrocardiograph during uninterrupted chest compressions in cardiac arrest patients. [2019]

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

Effective compression ratio--a new measurement of the quality of thorax compression during CPR. [2013]

9. Greece pubmed.ncbi.nlm.nih.gov

Benefit of cardiac sonography for estimating the early term survival of the cardiopulmonary arrest patients. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Hands-off time during insertion of six airway devices during cardiopulmonary resuscitation: a randomised manikin trial. [2011]

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

Double-balloon technique for embolization of carotid cavernous fistulas. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Super-Elastic Carbonized Mushroom Aerogel for Management of Uncontrolled Hemorrhage. [2023]

13. Scotland pubmed.ncbi.nlm.nih.gov

Intraprocedural rupture management for intracranial aneurysm rupture during coil embolization by manual common carotid artery compression. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Treatment of carotid-cavernous fistula using a balloon-tipped intra-arterial catheter. [2019]

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

Brachial plexus and supraclavicular nerve injury caused by manual carotid compression for spontaneous carotid-cavernous sinus fistula. [2019]