Sotair for Manual Resuscitation

Overseen By SIMON BLACKBURN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SafeBVM

Disqualifiers: Medical school, Respiratory therapy school

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test different methods of manual ventilation, the process of assisting breathing with a hand-held bag. The research will evaluate the effectiveness of three setups in scenarios simulating various lung conditions. Participants will assess a standard resuscitator bag, a flow-limiting bag, and a flow rate limiting device combined with a standard bag. Ideal participants are adults with basic life support certification who can commit to a 10-hour session. As an unphased trial, this study allows participants to contribute to innovative research that could enhance emergency medical care techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for manual resuscitation?

Research has shown that the Sotair device, when used with manual resuscitators, maintains safe air flow rates. It controls the air entering the lungs, preventing issues like over-inflation. Studies indicate it effectively limits inhaled air, reducing high lung pressure.

The FDA has approved the device for use with manual resuscitators in patients unable to breathe independently. This approval confirms its safety in specific situations.

No specific data on negative effects appear in the sources, but the Sotair device's approval for similar uses offers some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sotair device because it could enhance manual resuscitation techniques. Unlike traditional methods using just an Ambu bag, the Sotair device is integrated into the process to potentially improve ventilation efficiency, particularly with patients who have low lung compliance. This innovation could lead to better patient outcomes by offering more consistent ventilation support. By investigating the performance of this new device in different lung compliance scenarios, researchers hope to discover improved strategies for manual ventilation, ultimately benefiting emergency and critical care protocols.

What evidence suggests that this trial's treatments could be effective?

Research has shown that the Sotair device, which participants in this trial may receive, could improve manual ventilation. Studies indicate it helps maintain important measures like peak airway pressure and tidal volume (the amount of air moving in and out of the lungs) near ideal levels. This improvement could make manual ventilation safer and more effective, especially compared to using a bag-valve-mask (BVM) alone. The FDA has approved the device for limiting airflow, which helps prevent excessive pressure that could harm the lungs. These features suggest that Sotair could become a new standard in emergency ventilation care. ^{6 7 8 9 10}

Who Is on the Research Team?

Mark Brady, MD

Principal Investigator

Brown Physicians, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals who are at least 18 years old with a current basic life support (BLS) certification. Participants must be available to complete the full 10-hour protocol. Those with medical or respiratory therapy school training, or who cannot commit to the full duration, are excluded.

Inclusion Criteria

I have a valid basic life support (BLS) certification.

I can be available for 10 hours to follow the study's procedure.

Exclusion Criteria

Any training in medical school or respiratory therapy school

I cannot commit to a full 10 hours for the study protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Simulation

Participants undergo simulated lung scenarios using various manual resuscitator bags and devices

10 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after simulation

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged Manual Ventilation Simulation

Trial Overview The study tests three methods of manual resuscitation: using a standard manual resuscitator bag, a flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator in simulated lung scenarios.

How Is the Trial Designed?

Group I: Ambu + Low lung compliance Active Control 1 Intervention

Manual ventilation with Ambu bag and low lung compliance.

Group II: Smart bag + Normal lung compliance Active Control 1 Intervention

Manual ventilation with smart bag and normal lung compliance.

Group III: Ambu + Sotair + Low compliance Active Control 1 Intervention

Manual ventilation with Ambu bag and Sotair device with low lung compliance.

Group IV: Ambu + Normal lung compliance Active Control 1 Intervention

Manual ventilation with Ambu bag and normal lung compliance.

Group V: Smart bag + Low lung compliance Active Control 1 Intervention

Manual ventilation with smart bag and low lung compliance.

Group VI: Ambu + Sotair + Normal lung compliance Active Control 1 Intervention

Manual ventilation with Ambu bag and Sotair device with normal lung compliance.

Who Is Running the Clinical Trial?

SafeBVM

Lead Sponsor

Trials

1

Recruited

100+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study of 2000 individuals, different methods of cardiopulmonary resuscitation (CPCR) training were evaluated, revealing that interactive workshops using lectures, human models, and educational films were the most effective in improving CPCR skills across all groups.

Long-term follow-up showed that participants who received this comprehensive training maintained better theoretical and practical knowledge, highlighting the importance of effective CPCR training for the general population to enhance confidence and potentially save lives in emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Teaching Methods in Mass CPCR Training in Different Groups of the Society, an Observational Study. Hasani, H., Bahrami, M., Malekpour, A., et al.[2021]

Training dental students in cardiopulmonary resuscitation (CPR) using a manikin showed that while ventilation amounts did not significantly change, many students still provided either too much or too little ventilation, indicating a need for better instruction on maintaining adequate ventilation without causing gastric distention.

The training effectively reduced the number of students performing shallow chest compressions, from about 80% to 67%, and significantly improved the correct positioning for compressions, suggesting that focused training can enhance CPR technique among students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Judgement on students' exercise for resuscitation using a manikin for CPCR exercise (1st report)]. Ishibashi, H., Shibutani, K., Yoshii, H., et al.[2006]

Self-inflating manual resuscitators (SIMR) can malfunction due to issues like dried pulmonary secretions, which can prevent proper ventilation of patients, highlighting the importance of device maintenance.

The case emphasizes the necessity for trained professionals to operate SIMRs, as even rare malfunctions can lead to potentially fatal consequences for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Failure of self-inflating manual resuscitator due to the presence of dried pulmonary secretions]. de Godoy, AC.[2014]

Lay rescuers perform higher quality chest compressions for one minute compared to two minutes, with better compression depth and fewer errors, based on a study of 148 participants.

To improve the effectiveness of cardiopulmonary resuscitation, it is recommended to rotate rescuers every minute, as this leads to better compression quality regardless of the rescuer's physical fitness or body mass index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of continuous chest compressions performed for one or two minutes. Gianotto-Oliveira, R., Gianotto-Oliveira, G., Gonzalez, MM., et al.[2022]

A structured method of CPR instruction significantly improved the quality of resuscitation performed by untrained individuals, with the experimental group showing better performance in key metrics such as compression depth and chest recoil compared to the control group.

The experimental group achieved an average compression depth of 51.1 mm and a chest recoil median of 86.32%, demonstrating that clear, standardized instructions can enhance CPR effectiveness in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relief Alternatives during Resuscitation: Instructions to Teach Bystanders. A Randomized Control Trial. Pujalte-Jesús, MJ., Leal-Costa, C., Ruzafa-Martínez, M., et al.[2020]

A computer-based voice advisory manikin significantly improved CPR skills immediately after training, with correct compression depth increasing from 33% to 77% and correct inflations from 9% to 58%.

Participants who underwent additional overtraining sessions retained their skills better after 6 months, showing 61% correct compression depth and 42% correct inflations, compared to the control group whose skills declined to near pre-training levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention of basic life support skills 6 months after training with an automated voice advisory manikin system without instructor involvement. Wik, L., Myklebust, H., Auestad, BH., et al.[2019]

In a study of 262 participants who received conventional CPR training, significant skill acquisition issues were identified, particularly in ventilation techniques, with only 33% successfully opening the airway and 18% providing ideal ventilation volumes immediately after training.

After 6-9 months, all tested CPR skills showed significant decay, except for ventilation volume, highlighting the need for regular re-training, although the benefits of re-training were modest and only significantly improved two out of ten skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trials of teaching methods in basic life support (3): comparison of simulated CPR performance after first training and at 6 months, with a note on the value of re-training. Chamberlain, D., Smith, A., Woollard, M., et al.[2022]

The Thumper cardiopulmonary resuscitator (CPR) significantly increased the return of spontaneous circulation (ROSC) rate compared to bare-handed CPR, with rates of 68.57% versus 51.25%, indicating its greater efficacy in emergency situations.

Patients receiving Thumper CPR showed better blood gas metrics, including higher arterial oxygen partial pressure (PaO2) and oxygen saturation (SaO2), and lower carbon dioxide partial pressure (PaCO2) and lactic acid levels, suggesting improved metabolic outcomes during resuscitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative study for effects of bare-handed CPR with Thumper cardiopulmonary resuscitator CPR in emergency department based on "the Utstein style"]. Zhang, C., Wang, Y., Liu, H., et al.[2019]

Most manual resuscitators (MRs) tested met the American Society for Testing and Materials (ASTM) criteria for expiratory resistance, with only one MR exceeding the acceptable limit.

Brazilian-made MRs often had pressure-limiting valves that opened at low pressures, resulting in lower tidal volumes (VT) than the recommended 600 mL, especially when using a one-handed technique, indicating a need for two-handed use and potential adjustment of the pressure-limiting valve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of manual resuscitators used in ICUs in Brazil. Ortiz, Tde A., Forti, G., Volpe, MS., et al.[2021]

Current CPR techniques, established since 1960, have not significantly improved long-term survival rates after cardiac arrest, which remain low at 5-10%.

New CPR methods like interposed abdominal compression (IAC) and active compression-decompression (ACD) show promise in improving blood flow and long-term survival, but further research is needed to validate their effectiveness compared to standard CPR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative cardiopulmonary resuscitation devices. O'Connor, RE., Ornato, JP., Wigginton, J., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06805838

NCT06805838 | Prolonged Manual Ventilation Simulation Adult Sotair® device has FDA clearance as a Class II device through the 510(k) pathway (K212905) for the intended use of "Flow-limiting, safe, and optimal ...

2. reporter.nih.gov reporter.nih.gov/project-details/11255917

Project Details - NIH RePORTER This innovation positions Sotair as the new gold standard for manual ventilation, enabling safer and more effective care even in resource- limited emergency ...

3. researchsquare.com researchsquare.com/article/rs-513900/latest.pdf

Device in Manual Ventilation of Different Lung Compliances Results: We found that the SotairTM device helped maintain PIP and TV closer to mechanical ventilator baseline levels than BVM only ventilation ...

4. safebvm.com safebvm.com/sotair-literature/

Sotair® Literature & Ongoing Clinical Trials This study demonstrates that SafeBVM's Sotair flow-limiting device significantly improves manual ventilation control, ensuring peak airway pressures remain ...

5. trialx.com trialx.com/clinical-trials/listings/251923/non-inferiority-trial-between-sotair-device-attached-to-manual-resuscitator-versus-mechanical-ventilation/

Non-inferiority Trial Between Sotair® Device Attached to ... Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe ...

6. safebvm.com safebvm.com/sotair/

Sotair The valve prevents flow rates of air from exceeding 55 LPM during manual ventilation, ensuring that air delivery stays within safe limits. Flow control helps ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K212905.pdf

K212905 - Sara Toyloy - accessdata.fda.gov The Sotairm device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow ...

8. liebertpub.com liebertpub.com/doi/10.1089/respcare.12363

Manual Ventilation Performance With Safety Device in ... A new flow-limiting device (Sotair by SafeBVM, Boston, Massachusetts) limits inspiratory flow during manual ventilation, thus minimizing peak inspiratory ...

9. rescue-essentials.com rescue-essentials.com/content/Sotair%20Literature%20ALL.pdf?srsltid=AfmBOor6HS024oa4sTuQrGmOa0Cm4nI1bGql0gjei0OWEPgKWyZ-rYGG

Sotair Literature ALL.pdf SafeBVM Corp. is developing the universally compatible Sotair Device to prevent gastric insufflation during manual ventilation with the. BVM. In regular use, ...

10. innovations.bmj.com innovations.bmj.com/content/7/2/297

Feasibility of manual ventilation replacing mechanical ... The mean (±SD) tidal volume with bag only was 563.9±128.8 mL and with the safety device 536.1±80.9 mL (p<0.0001). The mean peak inspiratory pressure with bag ...