AirSeal® System Pressure Management for Pneumoperitoneum

(PRESSURE Trial)

Overseen By Michelle R Jacobs, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Akron Children's Hospital

Must not be taking: Systemic steroids

Disqualifiers: Immunodeficiency, Diabetes, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: During procedure

102 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms: 1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or 2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using systemic steroids or have certain health conditions like uncontrolled diabetes, you may not be eligible to participate.

What data supports the effectiveness of the AirSeal® Insufflation System treatment?

The AirSeal® Insufflation System is shown to provide stable pressure during laparoscopic surgeries, which can lead to shorter surgery times and potentially less post-operative pain in some cases. However, the overall complication rates and recovery times are similar to standard systems, and more research is needed to confirm its benefits. ^{1 2 3 4 5}

How is the AirSeal® System treatment different from other treatments for pneumoperitoneum?

The AirSeal® System is unique because it is a valve-free insufflation system that maintains stable pressure in the abdomen during surgery, while also continuously removing smoke and recirculating carbon dioxide. This differs from standard systems that may not offer the same level of pressure stability and smoke evacuation. ^{1 2 3 4 6}

Research Team

Todd Ponsky, MD

Principal Investigator

Akron Children's Hospital

Eligibility Criteria

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.

Inclusion Criteria

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

Capable and willing to provide parental Informed Consent and patient Assent

I am considered fit for keyhole surgery.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic surgery with AIS at either low or high insufflation pressure

During procedure

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative shoulder pain and other secondary outcomes

Up to 10 days

Daily assessments until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AirSeal® Insufflation System (AIS)

Trial Overview 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.

Participant Groups

Group I: LOW AIS Pressure AirSeal® Experimental Treatment 1 Intervention

AIS with an insufflation pressure target of 9mmHg ±1mmHg

Group II: HIGH AIS Pressure AirSeal® Experimental Treatment 1 Intervention

AIS with an insufflation pressure target of 15mmHg ±1mm

Who Is Running the Clinical Trial?

Akron Children's Hospital

Lead Sponsor

Trials

50

Recruited

5,009,000+

Findings from Research

The AIRSEAL® insufflation device is feasible for use in laparoscopic surgery, with a total of 1394 participants across 10 studies showing similar complication rates compared to standard CO2 insufflators.

While some studies indicated a potential reduction in post-operative pain and shorter operative duration with AIRSEAL®, the results were inconsistent, highlighting the need for further research to confirm its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Organizational Impact of the AIRSEAL&#174; Insufflation System During Laparoscopic Surgery: A Systematic Review. Balayssac, D., Selvy, M., Martelin, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of a standard CO₂ pressure pneumoperitoneum insufflator versus AirSeal: study protocol of a randomized controlled trial. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal&#174;. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: A Randomized Controlled Trial. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of a simple valve mechanism used to stabilize intraabdominal pressure during surgically induced pneumoperitoneum in small animals. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical and Organizational Impact of the AIRSEAL&#174; Insufflation System During Laparoscopic Surgery: A Systematic Review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of the Safety and Efficacy of Valveless and Standard Insufflation During Robotic Partial Nephrectomy: A Prospective, Randomized, Multi-institutional Trial. [2022]