AirSeal® System Pressure Management for Pneumoperitoneum (PRESSURE Trial)

N/A

Waitlist Available

Led By Todd Ponsky, MD

Research Sponsored by Akron Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric subjects (<21 years of age) > 20 kg in weight

Be younger than 65 years old

Must not have

Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids

Active cutaneous infection or inflammation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-anesthesia care unit (pacu) discharge, up to 24 hours.

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to see if there is a difference in physician preference when the SurgiQuest AirSeal® Insufflation System is used at a low pressure vs. a high pressure for the management of pneumoperitoneum.

Who is the study for?

This trial is for pediatric patients under 21 years old, weighing over 20 kg, who are suitable for laparoscopic surgery. It's not for those with infections, immune disorders, uncontrolled diabetes, severe bleeding risks or anemia, extreme obesity (BMI >45), or a life expectancy under 30 days. Pregnant or breastfeeding females and participants in other studies are excluded.

What is being tested?

The study tests the SurgiQuest AirSeal® Insufflation System at two different pressures (low: around 9mmHg and higher: around 15mmHg) to manage pneumoperitoneum during surgery. Participants will be randomly assigned to one of these two pressure settings in equal numbers.

What are the potential side effects?

Potential side effects may include discomfort due to varying insufflation pressures which could lead to shoulder pain post-surgery; however specific side effects related to the device itself are not detailed.

Eligibility Criteria

Inclusion Criteria

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

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I am under 21 years old and weigh more than 20 kg.

Exclusion Criteria

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

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I have an immune system disorder or I take steroids regularly.

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I currently have a skin infection or inflammation.

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I do not have severe health issues limiting my life expectancy to under 30 days.

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My BMI is over 45.

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My diabetes is not well-managed.

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I am not pregnant, planning to become pregnant soon, or breastfeeding.

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I have fluid buildup in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first. for reporting.