102 Participants Needed

Sotair for Manual Resuscitation

MB
SB
Overseen BySIMON BLACKBURN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: SafeBVM
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

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

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.12345

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.13678

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.257910

Who Is on the Research Team?

MB

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?
6Treatment groups
Active Control
Group I: Ambu + Low lung complianceActive Control1 Intervention
Group II: Smart bag + Normal lung complianceActive Control1 Intervention
Group III: Ambu + Sotair + Low complianceActive Control1 Intervention
Group IV: Ambu + Normal lung complianceActive Control1 Intervention
Group V: Smart bag + Low lung complianceActive Control1 Intervention
Group VI: Ambu + Sotair + Normal lung complianceActive Control1 Intervention

Find a Clinic Near You

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

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.
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.
[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.
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]

Citations

Alternative cardiopulmonary resuscitation devices. [2019]
[Comparative study for effects of bare-handed CPR with Thumper cardiopulmonary resuscitator CPR in emergency department based on "the Utstein style"]. [2019]
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]
Evaluation of Teaching Methods in Mass CPCR Training in Different Groups of the Society, an Observational Study. [2021]
Relief Alternatives during Resuscitation: Instructions to Teach Bystanders. A Randomized Control Trial. [2020]
Evaluation of manual resuscitators used in ICUs in Brazil. [2021]
[Failure of self-inflating manual resuscitator due to the presence of dried pulmonary secretions]. [2014]
Quality of continuous chest compressions performed for one or two minutes. [2022]
Retention of basic life support skills 6 months after training with an automated voice advisory manikin system without instructor involvement. [2019]
[Judgement on students' exercise for resuscitation using a manikin for CPCR exercise (1st report)]. [2006]
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