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Device

Sotair Device for Artificial Respiration

N/A
Recruiting
Led By Mark Kendall, MD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
American Society Of Anesthesiologists Physical Status 1 and 2
Adult patients who are scheduled for non-emergency surgery with general anesthesia (with artificial airway) at Rhode Island Hospital
Must not have
American Society of Anesthesiologists Physical Status >3 (e.g. respiratory disease)
Oropharyngeal or facial pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded every thirty seconds for a total duration of 3 minutes for each arm of the study
Awards & highlights

Summary

This trial will test a new disposable safety device called Adult Sotair® that aims to improve the delivery of manual ventilation. Researchers will compare the effectiveness of this device to manual ventilation alone using a two

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include issues related to improper ventilation such as low oxygen levels or high pressures in the lungs when using either the Sotair® device or standard manual methods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in good health or have mild systemic disease.
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I am an adult scheduled for a planned surgery under general anesthesia at Rhode Island Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My health status is considered high risk for surgery due to conditions like severe respiratory disease.
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I have a disease affecting my throat or face.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded every thirty seconds for a total duration of 3 minutes for each arm of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded every thirty seconds for a total duration of 3 minutes for each arm of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak airway pressure
Secondary outcome measures
Airflow
Tidal volume

Trial Design

2Treatment groups
Active Control
Group I: Bag mask ventilation with Adult Sotair deviceActive Control1 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 ventilationActive Control1 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.

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
262 Previous Clinical Trials
69,002 Total Patients Enrolled
1 Trials studying Airway Management
310 Patients Enrolled for Airway Management
Mark Kendall, MDPrincipal InvestigatorRhode Island Hospital
2 Previous Clinical Trials
378 Total Patients Enrolled
1 Trials studying Airway Management
310 Patients Enrolled for Airway Management
~16 spots leftby Jan 2025
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