← Back to Search

Device

Bag mask ventilation with Adult Sotair device for Airway Management

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

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

Study 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

Select...

I am in good health or have mild systemic disease.

Select...

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

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,977 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

Frequently Asked Questions

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

Does this research study have an age limit for potential participants, specifically individuals who are 50 years old or older?

"Eligible candidates for this research project must fall within the age range of 18 to 80. Additionally, there are separate studies available with 4 trials dedicated to individuals under 18 and another 14 focusing on those above 65 years old."

Answered by AI

Are there currently any available slots for new participants in this medical trial?

"The trial, as indicated on clinicaltrials.gov, is presently enrolling participants. Initially shared on 2/19/2024 and most recently revised on 2/7/2024."

Answered by AI

What is the current total number of participants being recruited for this clinical study?

"Indeed, the details on clinicaltrials.gov show that patient recruitment is ongoing for this investigation. Originally listed on February 19th, 2024, with the latest update made on February 7th, 2024, the trial aims to enroll a total of 30 participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

Mark Kendall 2024. "Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261619.

All > Paid Studies Boston