Sotair® Device for Artificial Respiration

Overseen By Mark Brady, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Respiratory disease, Oropharyngeal pathology, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 minutes

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Adult Sotair®, designed to assist breathing during surgery. The goal is to determine if the Sotair® device performs as effectively as traditional mechanical ventilators in safely moving air in and out of the lungs. The study will compare patients' breathing with the Sotair® device versus a regular ventilator. Adults undergoing non-emergency surgery at Rhode Island Hospital and in good physical health may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Sotair Device is safe for artificial respiration?

Research shows that the Adult Sotair® device enhances the safety of manual breathing support. Studies indicate that this device helps control the flow and pressure of air during patient respiration. It uses special valves and provides signals to the operator, maintaining steady air pressure and reducing the risk of lung injuries. Although the device remains under testing, no clear evidence of negative effects in humans has emerged. Its design aims to prevent common issues associated with other manual breathing methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sotair® device for artificial respiration because it offers a novel approach to ventilation. Unlike standard mechanical ventilators that can be cumbersome and require complex settings, the Sotair® device is designed for manual bag ventilation, allowing for a more hands-on and potentially more controlled delivery of air. This feature could be particularly beneficial in settings where quick, efficient respiratory support is needed, such as during anesthesia. By comparing the Sotair® device with traditional methods, researchers hope to discover if it provides more consistent pressure and flow, which could lead to improved patient outcomes during critical respiratory support scenarios.

What evidence suggests that the Sotair Device is effective for artificial respiration?

Research shows that the Adult Sotair® device aids manual breathing support by controlling airflow and maintaining safe pressure levels. Studies have found that it greatly improves ventilation management, which is vital for effective breathing assistance. This trial will compare two approaches: one group will receive bag mask ventilation with the Adult Sotair® device, while another group will undergo mechanical ventilation. The device maintains safe and steady airway pressures, crucial for preventing lung damage. These findings suggest that the Adult Sotair® device could be as effective as mechanical ventilation in providing safe breathing support. ^{1 3 5 6 7}

Who Is on the Research Team?

Mark Kendall, MD

Principal Investigator

Rhode Island Hospital

Are You a Good Fit for This Trial?

This trial is for adults in good or fair health (ASA physical status 1 and 2) who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital. They must not have a high risk of difficult mask ventilation, severe respiratory diseases, or any facial pathologies.

Inclusion Criteria

I am an adult scheduled for a planned surgery under general anesthesia at Rhode Island Hospital.

I am in good health or have mild systemic disease.

A score of ≤ 2 out of 5 using the difficult mask ventilation criteria as described by Langeron et al.

Exclusion Criteria

I have a disease affecting my throat or face.

My health is severely limited by a condition like severe respiratory disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo ventilation using either the Sotair® device or mechanical ventilation for 3 minutes

3 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• ADULT Sotair Device

Trial Overview The study is testing the Adult Sotair® device attached to a manual resuscitator against standard mechanical ventilation to see if it's just as effective in providing safe breathing support during surgery.

How Is the Trial Designed?

Group I: Mechanical Ventilation Active Control 1 Intervention

The anesthesia provider will remove the bag valve mask and Adult Sotair® device and connect the patient to the mechanical ventilator. The recording of pressure and flow will last for 3 minutes.

Group II: Bag mask ventilation with Adult Sotair device Active Control 1 Intervention

The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes.

ADULT Sotair Device is already approved in United States for the following indications:

Approved in United States as Sotair Device for:

• Manual ventilation assistance for adult patients requiring flow-controlled ventilation

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Published Research Related to This Trial

Biologic disease-modifying anti-rheumatic drugs (bDMARDs) can be tapered in patients with rheumatoid arthritis who have maintained remission for at least six months, optimizing their benefit/risk balance.

A progressive tapering strategy, guided by disease activity monitoring, is recommended to effectively manage potential relapses while ensuring continued control of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Discontinuation or tapering strategies of biologics in rheumatoid arthritis in remission]. Mallick, A., Fautrel, B., Sagez, F., et al.[2017]

In a study of 51 rheumatoid arthritis patients who were new to biological treatments, 29 achieved remission after 36 weeks of abatacept (ABT) therapy, and 86.2% of these patients maintained remission after tapering the medication for an additional 12 weeks.

While most patients sustained low disease activity (DAS28-CRP scores), there was a significant increase in the total power Doppler score, indicating some changes in joint inflammation, suggesting that careful monitoring with ultrasonography is important after tapering ABT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of abatacept tapering therapy for sustained remission in patients with rheumatoid arthritis: Prospective single-center study. Yoshida, S., Kotani, T., Kimura, Y., et al.[2019]

A modified adult ventilator, designed for neonates and small children, allows for mechanical ventilation using the Ayre's T-piece circuit, simplifying the adjustment process compared to other conversion methods.

The ventilator can deliver tidal volumes between 10 and 300 ml at frequencies of 10 to 85 breaths per minute, making it suitable for the specific needs of neonatal and pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic ventilation with the Ayre's T-piece. A modification of the Nuffield Series 200 ventilator for neonatal and paediatric use. Newton, NI., Hillman, KM., Varley, JG.[2019]

In an 18-month trial involving 137 patients with rheumatoid arthritis in remission, tapering TNF-blocker injections led to a higher rate of relapses (76.6%) compared to maintenance therapy (46.5%), indicating that tapering may not be a safe option for all patients.

Despite the increased relapse rate with tapering, there was no significant difference in the progression of structural joint damage between the two groups, suggesting that while tapering may lead to more flare-ups, it does not worsen long-term joint health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: results of the multicentre non-inferiority randomised open-label controlled trial (STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study). Fautrel, B., Pham, T., Alfaiate, T., et al.[2022]

The pneuPAC Model 2-R ventilator is designed for versatility in critical care, offering adjustable oxygen levels (FIO2 of 1.0 or 0.45) and features like positive end-expiratory pressure, making it suitable for transporting critically ill patients.

The ventilator's performance was tested with both a piped gas supply and new medical air compressors, ensuring reliable operation in various settings, including emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pneuPAC ventilator with new patient valve and air compressors. Park, GR., Manara, AR., Bodenham, AR., et al.[2019]

A systematic review of 49 observational studies found that patients with rheumatoid arthritis using tumor necrosis factor inhibitors (TNFi) have a higher risk of serious infections, including tuberculosis and herpes zoster, compared to those on conventional synthetic DMARDs.

No new safety concerns were identified for conventional synthetic DMARDs, and TNFi did not show an increased risk for most malignancies, although there may be a slightly elevated risk for melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ramiro, S., Gaujoux-Viala, C., Nam, JL., et al.[2022]

A new PEEP valve has been developed for manually operated resuscitators, allowing for the application of positive end-expiratory pressure (PEEP) during artificial ventilation, which is crucial for treating critically ill patients in intensive care units.

This valve can be easily connected to various resuscitators and maintains consistent PEEP levels independent of airflow, ensuring effective ventilation for both adults and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new positive end-expiratory pressure valve for manually operated artificial ventilation. Dick, W., Milewski, P., Lotz, P., et al.[2019]

Mortality rates for Acute Respiratory Distress Syndrome (ARDS) have improved significantly, now ranging from 20-40%, compared to earlier rates of 40-60%, highlighting advancements in treatment and management.

Predicting outcomes in ARDS can be enhanced by measuring inflammatory mediators and surfactant-associated proteins, rather than relying solely on traditional respiratory indices, which have limited predictive ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute lung injury: outcomes and new therapies. Numa, AH.[2020]

A systematic review of 59 studies found that biological DMARDs (bDMARDs) may carry a higher risk of serious infections compared to conventional synthetic DMARDs (csDMARDs), with specific concerns about herpes zoster infections being more prevalent with JAK inhibitors (JAKi).

Tofacitinib, a type of JAKi, showed a higher risk of malignancies and major adverse cardiovascular events (MACE) compared to TNF inhibitors (TNFi) in patients with cardiovascular risk factors, indicating a need for careful monitoring in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis. Sepriano, A., Kerschbaumer, A., Bergstra, SA., et al.[2023]

A new PEEP device has been created for manually operated resuscitators, allowing for the application of Positive End-Expiratory Pressure (PEEP) during artificial ventilation, which is crucial for improving oxygenation.

This device is versatile, compatible with both adult and neonatal resuscitators, and allows for adjustable PEEP levels from 0 to +10 cm H2O, enhancing its utility in various emergency situations, including patient transport.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New PEEP device--application of PEEP and CPAP during manually operated ventilation (author's transl)]. Dick, W., Milewski, P., Traub, E.[2006]

Citations

1. 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 ...

2. 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 ...

3. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/respcare.12363

Manual Ventilation Performance With Safety Device in ... This study examined the differences in flow, pressure, and tidal volume (VT) during ventilation with a manual resuscitator connected to the flow-limiting device ...

4. withpower.com withpower.com/trial/phase-airway-management-10-2023-a7efb

Sotair® Device for Artificial Respiration A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this non-inferiority study, we will perform a pre-post study ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06117683/non-inferiority-trial-between-sotairr-device-attached-to-manual-resuscitator-versus-mechanical-ventilation

Non-inferiority Trial Between Sotair® Device Attached to ... A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag ...

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

Manual Ventilation Performance With Safety Device in ... This study examined the differences in flow, pressure, and tidal volume (VT) during ventilation with a manual resuscitator connected to the flow-limiting device ...

7. reporter.nih.gov reporter.nih.gov/search/kuJjoQHOmUuh8fqYCh_S-w/project-details/10708832

Project Details The proposed device will control flow rates by integrating flow blocking and pressure release valves. It will provide haptic and audiovisual feedback to ...