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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Effective respiratory ventilation is achieved by moving the right amount of air to 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 superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

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

The research on a new positive end-expiratory pressure (PEEP) valve shows that it can be effectively used with manually operated resuscitators for both adults and children, providing consistent pressure during artificial ventilation. This suggests that similar devices, like the Sotair Device, may also be effective in supporting artificial respiration by maintaining necessary pressure levels. ^{1 2 3 4 5}

What safety data exists for the Sotair Device for Artificial Respiration?

There is no specific safety data available for the Sotair Device for Artificial Respiration in the provided research articles. ^{6 7 8 9 10}

How does the Sotair Device treatment differ from other treatments for artificial respiration?

The Sotair Device is unique because it incorporates a positive end-expiratory pressure (PEEP) valve that can be attached to manually operated resuscitators, allowing for consistent pressure during artificial ventilation. This feature is particularly useful for transporting critically ill patients, as it maintains effective ventilation without requiring complex equipment. ^{2 3 11 12 13}

Research Team

Mark Kendall, MD

Principal Investigator

Rhode Island Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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 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 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]

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 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]

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]

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]

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]

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]

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. Ireland pubmed.ncbi.nlm.nih.gov

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

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of a new spacer device for drug inhalation. [2019]

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

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

7. United States 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]

8. England 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. [2023]

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

Safer healthcare at home: Detecting, correcting and learning from incidents involving infusion devices. [2019]

10. China pubmed.ncbi.nlm.nih.gov

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

11. Germany 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)]. [2006]

12. England pubmed.ncbi.nlm.nih.gov

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

13. Germany pubmed.ncbi.nlm.nih.gov

[Respiratory controlled intermittent inspiratory pleural drainage--a method for handling life threatening bronchopleural fistulas]. [2006]