AirSeal® System Pressure Management for Pneumoperitoneum
(PRESSURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how doctors prefer to use the AirSeal® Insufflation System during laparoscopic surgery. Researchers aim to determine if preference varies between using lower pressure (around 9mmHg) and higher pressure (around 15mmHg) to manage the abdominal space during surgery. The trial targets children and teenagers weighing more than 20 kg (about 44 pounds) who are already scheduled for laparoscopic surgery. Participants must not have certain health conditions, such as uncontrolled diabetes or severe anemia (low red blood cell count). As an unphased trial, this study allows participants to contribute to understanding surgical preferences that could enhance future procedures.
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 prior data suggests that the AirSeal® Insufflation System is safe for managing pneumoperitoneum?
Research has shown that the AirSeal® Insufflation System (AIS) is generally safe for surgeries. One study found the AirSeal system to be as safe as traditional methods, with even better results. Patients experienced less post-operative pain and improved breathing during the procedure. Another study discovered that the AirSeal system shortened surgery times, potentially reducing risks for patients.
Overall, these studies suggest that the AirSeal system is well-tolerated and safe for various types of surgeries. No major safety issues have been reported, making it a promising option for managing pressure during operations.12345Why are researchers excited about this trial?
Researchers are excited about the AirSeal® Insufflation System (AIS) for managing pneumoperitoneum because it offers a new level of precision in pressure control during laparoscopic surgeries. Unlike traditional insufflation methods that often use higher and less consistent pressures, AIS allows for very specific pressure targets, either low at 9mmHg or high at 15mmHg, with minimal fluctuation. This precision could potentially lead to fewer complications, improved patient outcomes, and a more comfortable recovery period. By refining pressure management, AIS aims to enhance surgical efficiency and safety, setting it apart from current options.
What evidence suggests that the AirSeal® Insufflation System is effective for managing pneumoperitoneum?
Studies have shown that the AirSeal® Insufflation System (AIS) can lead to better results during and after surgery compared to traditional methods. Research indicates that patients using AirSeal® experience less postoperative pain and have lower airway pressure, making recovery more comfortable. Additionally, the system maintains stable pressure during surgery, which is crucial for keeping the operation area clear and safe. This trial will compare two different pressure settings of the AIS: a low pressure target of 9mmHg ±1mmHg and a high pressure target of 15mmHg ±1mmHg. Previous studies suggest that patients tend to spend less time in the hospital and recover faster when AIS is used. Overall, the AirSeal® system has proven effective in improving surgical experiences and outcomes.12367
Who Is on the Research Team?
Todd Ponsky, MD
Principal Investigator
Akron Children's Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopic surgery with AIS at either low or high insufflation pressure
Post-operative Monitoring
Participants are monitored for post-operative shoulder pain and other secondary outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AirSeal® Insufflation System (AIS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Akron Children's Hospital
Lead Sponsor