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

Trial Summary

What is the purpose of this trial?

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 level. 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 design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.

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 data supports the effectiveness of the Sotair® Device for Artificial Respiration treatment?

The research mentions the use of positive end-expiratory pressure (PEEP) in artificial ventilation, which is a component of the Sotair Device. PEEP is considered essential for treating critically ill patients in intensive care, suggesting that the Sotair Device may be effective in providing necessary respiratory support. ^{1 2 3 4 5}

How is the Sotair Device treatment different from other treatments for artificial respiration?

The Sotair Device for artificial respiration is unique because it is a mechanical device specifically designed to assist with breathing, unlike traditional drug-based treatments. This device may offer a novel approach by providing a physical means to support or enhance respiratory function, which is different from medications that typically target underlying causes or symptoms. ^{6 7 8 9 10}

Research Team

Mark Kendall, MD

Principal Investigator

Rhode Island Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

References

1. England 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. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[New PEEP device--application of PEEP and CPAP during manually operated ventilation (author's transl)]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

The pneuPAC ventilator with new patient valve and air compressors. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

A new positive end-expiratory pressure valve for manually operated artificial ventilation. [2019]

6. England 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). [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Discontinuation or tapering strategies of biologics in rheumatoid arthritis in remission]. [2017]

8. England 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of abatacept tapering therapy for sustained remission in patients with rheumatoid arthritis: Prospective single-center study. [2019]

10. England 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. [2022]