Sotair Device for Artificial Respiration

Overseen By Mark Kendall, 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)

Compensation: Varies

Number of Visits: 1

Duration: 3 minutes per arm

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 improve the safety and effectiveness of breathing support during surgery. The researchers aim to determine if this device outperforms the usual manual ventilation method. Participants will use both the new device and the standard method for comparison. This trial suits adults scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital, who do not have major health issues or facial problems. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical safety and effectiveness.

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

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

What prior data suggests that the Adult Sotair Device is safe for respiratory ventilation?

Research has shown that the Adult Sotair Device enhances safety during manual ventilation. It limits airflow to 55 liters per minute and adjusts pressure according to the patient's needs, helping to prevent over-ventilation, which occurs when excessive air enters the lungs.

Studies indicate that this device maintains safe airway pressures and improves control during assisted breathing. Weighing only 14 grams, it is compatible with all standard bag-valve masks used for breathing assistance. The device requires no external power source, making it versatile for use in various settings.

Overall, the Adult Sotair Device appears well-tolerated, with no major safety concerns reported in the available research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sotair device for artificial respiration because it introduces a novel approach to bag mask ventilation. Unlike standard bag mask ventilation techniques, the Sotair device offers a more controlled and potentially more effective method of delivering breaths manually. Its design aims to optimize the delivery of air, potentially improving patient outcomes during anesthesia and emergency situations. This innovation could lead to a more consistent and efficient ventilation process, addressing some limitations of traditional methods.

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

Studies have shown that the Adult Sotair device can significantly enhance manual ventilation. It controls airflow and maintains safe lung pressure levels. In this trial, one group will receive bag mask ventilation with the Adult Sotair device, while another group will receive standard bag mask ventilation without it. Research indicates that using Sotair with a manual resuscitator manages air and pressure more effectively than manual methods alone. The device is lightweight and compatible with existing equipment, suggesting it might improve breathing support during medical procedures. ^{1 2 4 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 individuals who require artificial respiration and airway management. The specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed inclusion and exclusion criteria.

Inclusion Criteria

I am in good health or have mild systemic disease.

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

Exclusion Criteria

My health status is considered high risk for surgery due to conditions like severe respiratory disease.

I have a disease affecting my throat or face.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo manual ventilation with and without the Adult Sotair® device in a cross-over design

3 minutes per arm

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 trial is testing a disposable safety device called Adult Sotair® attached to a manual resuscitator against standard manual ventilation alone. It uses a two-group crossover randomized design to determine if the Sotair® improves ventilation delivery.

How Is the Trial Designed?

Group I: 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 with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.

Group II: Bag mask ventilation Active Control 1 Intervention

The anesthesia provider will manually bag ventilate for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Published Research Related to This Trial

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]

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]

A review of 606 incident reports related to infusion devices used in home settings revealed that most incidents were due to device malfunctions, often leading to patients receiving inadequate doses of medication.

To enhance patient safety, the study suggests improving device feedback mechanisms and increasing monitoring and support from healthcare providers, emphasizing the need for devices to be better integrated into home care systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer healthcare at home: Detecting, correcting and learning from incidents involving infusion devices. Lyons, I., Blandford, A.[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]

The new inhalation spacer device (Rondo) demonstrated similar bronchodilating effects to conventional spacers when used with salbutamol, indicating its efficacy in treating asthma.

Patients found the Rondo spacer significantly easier to handle and more convenient to carry compared to the Volumatic spacer, suggesting improved acceptability for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new spacer device for drug inhalation. Stenius-Aarniala, B., Kiviranta, K., Poppius, H.[2019]

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]

The newly developed artificial ventilation device effectively manages patients with severe bronchopleural fistulae by controlling drainage suction during breathing cycles, ensuring that secretions do not affect its performance.

The report includes a case study demonstrating the device's effectiveness, and it suggests that the apparatus can be adapted for use with modern respirators, enhancing its potential for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Respiratory controlled intermittent inspiratory pleural drainage--a method for handling life threatening bronchopleural fistulas]. Gramm, HJ., Frucht, U., Simgen, WL., et al.[2006]

The FDA is reclassifying arrhythmia detector and alarm devices from class III to class II, indicating a shift to a lower regulatory burden based on new safety and efficacy information.

This reclassification is supported by petitions from industry groups and will be accompanied by a guidance document outlining special controls for the device, enhancing its monitoring capabilities for detecting serious heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical devices: cardiovascular devices: reclassification of the arrhythmia detector and alarm. Final rule. [2007]

The FDA has finalized a rule requiring medical device distributors to report deaths, serious illnesses, and injuries related to medical devices, enhancing safety monitoring.

Distributors, including importers, must now register their facilities and list their devices with the FDA, ensuring better oversight and accountability in the medical device industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date. [2000]

A safety analysis of ubrogepant and rimegepant, based on 2010 and 3691 adverse event reports respectively, identified 10 and 25 significant safety signals, indicating potential risks associated with these medications.

The adverse events reported were primarily related to psychiatric, neurological, gastrointestinal, skin, vascular, and infectious issues, highlighting the need for further research to confirm these safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. Battini, V., Carnovale, C., Clementi, E., et al.[2023]

The H.R.P.-I.M.V.-2000 device allows for advanced artificial respiration techniques to be used with various types of respirators, including older models, without requiring any modifications, making it versatile and user-friendly.

The E.S.-I.M.V. technique, which combines mandatory and patient-triggered breathing phases, reduces patient discomfort and the struggle against the respirator, enhancing the overall effectiveness of mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[H.R.P.-J.M.V.-200. A device for the simple adoption of modern ventilation techniques with various, even old, mechanical ventilators (author's transl)]. Lang, VO.[2006]

A new device was developed to digitally calculate and display key maximal expiratory flow values (PEF, MEF 75, MEF 50, MEF 25) during forced expiration, improving the measurement of flow-volume curves.

In a study involving 172 patients, the device demonstrated sufficient measuring accuracy, making it a practical tool for clinical use and screening in respiratory assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MEF test--an instrument for the determination of maximal expiratory flow values PEF, MEF 75, MEF 50, MEF 25]. Ohme, G.[2006]

Effective risk management for medical devices, particularly during their research and development stages, is crucial for ensuring patient safety and health outcomes.

The study highlights the need to integrate risk analysis with clinical application considerations, using the example of portable emergency ventilators to demonstrate specific hazards that can arise during clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Special Risk of Using Portable Emergency Ventilator Based on Clinical Application]. Xu, Y.[2020]

Citations

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

Project Details - NIH RePORTER At just 14 grams, Sotair is lightweight, compatible with all commercially available bag-valve masks and airway devices, and requires no external power source.

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

Sotair® Device for Artificial Respiration 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.

3. 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 ...

4. 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 ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06261619/superiority-trial-between-sotairr-device-attached-to-manual-resuscitator-versus-ventilation-alone

Superiority 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. rescue-essentials.com rescue-essentials.com/adult-sotair-flow-limiting-device/?srsltid=AfmBOoqSsUFaMP6TckQNlonWYPQcaSE1RnhIonz9XCxdD-IosQd6f8K6

Adult Sotair Flow Limiting Device The Sotair device limits air flow to 55 LPM, adjusts peak pressure based on patient needs, and prevents over-ventilation during manual ventilation.

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

Project Details Narrative Bag valve mask (BVM) resuscitators are frequently misused during emergency ventilation situations, leading to increased bodily harm and complications ...