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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

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

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

Blood pressure

End Tidal CO2

+4 more

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.

Group II: 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,697 Total Patients Enrolled

1 Trials studying Airway Management

30 Patients Enrolled for Airway Management

Mark Kendall, MDPrincipal InvestigatorRhode Island Hospital

2 Previous Clinical Trials

98 Total Patients Enrolled

1 Trials studying Airway Management

30 Patients Enrolled for Airway Management

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have restrictions on age for participants?

"The research requires that potential participants are between 18 and 80 years old. Those under 18 can join one of the 7 studies aimed at this group, while seniors above 65 have access to 12 different trials."

Answered by AI

May I enroll in this investigation?

"To be considered for enrollment in this clinical trial, prospective participants must have the ability to breathe independently and fall within an age range of 18 - 80 years old. The study is aiming to recruit a total of 310 individuals."

Answered by AI

Are there any vacancies for participation in this clinical trial?

"Yes, the information on clinicaltrials.gov confirms that this medical experiment is presently admitting applicants. This trial was posted to the website on November 1st 2023 and updated as recently as October 31st 2023. The study requires 310 volunteers from a single recruitment centre."

Answered by AI

How many participants are actively involved in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical investigation is currently enrolling patients; it was first published on November 1st 2023 and was most recently revised on October 31st 2023. 310 participants must be enrolled from a single centre of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Mark Kendall 2023. "Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06117683.