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

102 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Prolonged Manual Ventilation Simulation in the clinical trial Sotair for Manual Resuscitation?

The research on CPR training methods shows that structured and interactive learning, such as using human models and educational films, improves CPR skills and confidence, which could indirectly support the effectiveness of Prolonged Manual Ventilation Simulation by enhancing the skills needed for manual resuscitation. ^{1 2 3 4 5}

Is the Sotair treatment for manual resuscitation generally safe for humans?

The research articles do not provide specific safety data for Sotair or similar treatments like Prolonged Manual Ventilation Simulation. However, they discuss the performance and potential issues with manual resuscitators, such as valve malfunctions, which could be harmful if not addressed. ^{4 5 6 7 8}

How does the Sotair treatment for manual resuscitation differ from other treatments?

The Sotair treatment for manual resuscitation may involve unique features or mechanisms compared to standard manual resuscitators, such as improved design to prevent issues like valve malfunction due to dried pulmonary secretions, which can be a problem with self-inflating manual resuscitators. ^{2 6 7 9 10}

What is the purpose of this trial?

A pilot study on simulated lung scenarios using the standard manual resuscitator bag, flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator.

Research Team

Mark Brady, MD

Principal Investigator

Brown Physicians, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Alternative cardiopulmonary resuscitation devices. [2019]

2. China 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"]. [2019]

3. Ireland 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. [2022]

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

Evaluation of Teaching Methods in Mass CPCR Training in Different Groups of the Society, an Observational Study. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Relief Alternatives during Resuscitation: Instructions to Teach Bystanders. A Randomized Control Trial. [2020]

6. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of manual resuscitators used in ICUs in Brazil. [2021]

7. Brazil pubmed.ncbi.nlm.nih.gov

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

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

Quality of continuous chest compressions performed for one or two minutes. [2022]

9. Ireland 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. [2019]

10. Japan pubmed.ncbi.nlm.nih.gov

[Judgement on students' exercise for resuscitation using a manikin for CPCR exercise (1st report)]. [2006]