310 Participants Needed

Sotair® Device for Artificial Respiration

SF
MB
Overseen ByMark Brady, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rhode Island Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.678910

Who Is on the Research Team?

MK

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?
2Treatment groups
Active Control
Group I: Mechanical VentilationActive Control1 Intervention
Group II: Bag mask ventilation with Adult Sotair deviceActive Control1 Intervention

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

🇺🇸
Approved in United States as Sotair Device for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials
275
Recruited
71,400+

Published Research Related to This Trial

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

Citations

Automatic ventilation with the Ayre's T-piece. A modification of the Nuffield Series 200 ventilator for neonatal and paediatric use. [2019]
[New PEEP device--application of PEEP and CPAP during manually operated ventilation (author's transl)]. [2006]
Acute lung injury: outcomes and new therapies. [2020]
The pneuPAC ventilator with new patient valve and air compressors. [2019]
A new positive end-expiratory pressure valve for manually operated artificial ventilation. [2019]
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]
[Discontinuation or tapering strategies of biologics in rheumatoid arthritis in remission]. [2017]
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]
Efficacy of abatacept tapering therapy for sustained remission in patients with rheumatoid arthritis: Prospective single-center study. [2019]
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security