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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ recorded every thirty seconds for a total duration of 3 minutes for each arm of the study

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak airway pressure

Secondary study objectives

Airflow

Tidal volume

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met