Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure

Study Purpose

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.#46; 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Pediatric subjects (<21 years of age) 2. > 20 kg in weight; 3. Capable and willing to provide parental Informed Consent and patient Assent; 4. Acceptable candidate for laparoscopic surgery;

Exclusion Criteria:

1. Active cutaneous infection or inflammation; 2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 3. Uncontrolled diabetes mellitus. 4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR(international normalized ratio) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 5. Severe co-existing morbidities having a life expectancy of less than 30 days; 6. Currently involved in any other investigational clinical Studies; 7. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; 8. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 9. Extreme morbid obesity (BMI greater than 45 kg/m2) 10. Patients presenting with Ascites

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02837601
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Akron Children's Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Todd Ponsky, MD
Principal Investigator Affiliation	Akron Children's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Shoulder Pain

Additional Details

The study is designed and powered to demonstrate superiority of the AIS at low pressure vs.#46; at higher pressure on a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9mmHg ±1mmHg or to AIS with an insufflation target pressure of 15mmHg ±1mmHg. Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, length of hospital stay, aspects of anesthesia management including end tidal CO2 and the frequency of adverse events. These outcomes will be evaluated in a controlled population undergoing laparoscopic surgery.

Arms & Interventions

Arms

Other: LOW AIS Pressure AirSeal®

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

Other: HIGH AIS Pressure AirSeal®

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

Interventions

Device: - AirSeal® Insufflation System (AIS)

The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® iFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® iFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier.

Contact a Trial Team

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Akron, Ohio

Status

Address

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

Site Contact

Michelle R Jacobs, MA

[email protected]

330-543-4969

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