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Procedure

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

Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital

American Society of Anesthesiologists physical status 1 and 2

Must not have

Oropharyngeal or facial pathology

ASA PS >3 (e.g., respiratory disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up recorded for 3 minute duration for each arm of the study

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a disposable device to improve air flow into/out of lungs for safe breathing. It'll compare it to mechanical ventilation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial compares different methods of artificial respiration, potential side effects may include discomfort from the device, inadequate ventilation leading to low oxygen levels or high carbon dioxide levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am in good health or have mild systemic disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a disease affecting my throat or face.

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My health is severely limited by a condition like severe respiratory disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recorded for 3 minute duration for each arm of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recorded for 3 minute duration for each arm of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded for 3 minute duration 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

Blood pressure

End Tidal CO2

+4 more

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: Mechanical VentilationActive Control1 Intervention

The anesthesia provider will remove the bag valve mask and Adult Sotair® device and connect the patient to the mechanical ventilator. The recording of pressure and flow will last for 3 minutes.

Group II: Bag mask ventilation with Adult Sotair deviceActive Control1 Intervention

The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes.

0 / 4Eligibility criteria met