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Procedure
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during hospital stay up to 30 days
Awards & highlights
PRESSURE Trial 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.Check my eligibility
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.See study design
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.
PRESSURE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am under 21 years old and weigh more than 20 kg.
PRESSURE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative shoulder pain
Secondary outcome measures
Ease of anesthesia management
Length of Stay (LOS)
Length of recovery room stay
+4 morePRESSURE Trial Design
2Treatment groups
Experimental Treatment
Group I: LOW AIS Pressure AirSeal®Experimental Treatment1 Intervention
AIS with an insufflation pressure target of 9mmHg ±1mmHg
Group II: HIGH AIS Pressure AirSeal®Experimental Treatment1 Intervention
AIS with an insufflation pressure target of 15mmHg ±1mm
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Who is running the clinical trial?
Akron Children's HospitalLead Sponsor
47 Previous Clinical Trials
5,008,242 Total Patients Enrolled
Todd Ponsky, MDPrincipal InvestigatorAkron Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or I take steroids regularly.I currently have a skin infection or inflammation.I do not have severe health issues limiting my life expectancy to under 30 days.I am under 21 years old and weigh more than 20 kg.My BMI is over 45.I have a history of bleeding disorders or my current blood tests show clotting issues.My diabetes is not well-managed.Your blood doesn't have enough red cells, with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%.I am not pregnant, planning to become pregnant soon, or breastfeeding.I have fluid buildup in my abdomen.I am considered fit for keyhole surgery.
Research Study Groups:
This trial has the following groups:- Group 1: LOW AIS Pressure AirSeal®
- Group 2: HIGH AIS Pressure AirSeal®
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for participants to join this medical research project?
"According to clinicaltrials.gov, this study is no longer accepting participants; it was first advertised on March 1st 2021 and last updated on July 10th 2020. However, there are 79 other trials presently enrolling patients with similar criteria."
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