Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure (PRESSURE)
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ClinicalTrials.gov Identifier: NCT02837601 |
Recruitment Status :
Not yet recruiting
First Posted : July 19, 2016
Last Update Posted : July 13, 2020
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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:
- AIS with an insufflation pressure target of 9mmHg ±1mmHg; or
- AIS with an insufflation pressure target of 15mmHg ±1mmHg.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Shoulder Pain | Device: AirSeal® Insufflation System (AIS) | Not Applicable |
The study is designed and powered to demonstrate superiority of the AIS at low pressure vs. 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Single Center, Prospective, Randomized, Controlled Study To Evaluate Physician Preference Related To The Use Of The Surgiquest Airseal® Insufflation System (AIS) At Low Vs. Higher Pressure For The Management Of Pneumoperitoneum |
Estimated Study Start Date : | March 2021 |
Estimated Primary Completion Date : | November 2025 |
Estimated Study Completion Date : | November 2027 |
Arm | Intervention/treatment |
---|---|
LOW AIS Pressure AirSeal®
AIS with an insufflation pressure target of 9mmHg ±1mmHg
|
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. |
HIGH AIS Pressure AirSeal®
AIS with an insufflation pressure target of 15mmHg ±1mm
|
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. |
- Post-operative shoulder pain [ Time Frame: Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first. ]Severity of shoulder pain, which will be measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale or Wong-Baker FACES Pain Rating Scale, whichever is deemed more appropriate by the clinician assessing the patient.
- Pain severity and trend [ Time Frame: Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days. ]Severity of shoulder pain, back pain, abdominal pain. Pain will be measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale or Wong-Baker FACES Pain Rating Scale, whichever is deemed more appropriate by the clinician assessing the patient.
- Pressure stability [ Time Frame: During procedure ]Stability of intra-abdominal pressure
- Ease of anesthesia management [ Time Frame: During procedure ]Excessively high peak and/or mean airway pressures. Anesthesiologist reported difficulty with ventilation.
- Length of recovery room stay [ Time Frame: Post-anesthesia care unit (PACU) discharge, up to 24 hours. ]A measure of time the patient spends in the post-anesthesia recovery area
- Length of Stay (LOS) [ Time Frame: Until the time of hospital discharge, up to 10 days. ]The length of hospital stay associated with the surgery. This will be assessed through study completion. It is anticipated to be less than 10 days but could potentially exceed this length as the length of stay cannot always be predicted and there is no upper limit on hospital length of stay.
- Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs? [ Time Frame: During hospital stay up to 30 days ]
- Rate of device-related events [ Time Frame: During procedure ]

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pediatric subjects (<21 years of age)
- > 20 kg in weight;
- Capable and willing to provide parental Informed Consent and patient Assent;
- Acceptable candidate for laparoscopic surgery;
Exclusion Criteria:
- Active cutaneous infection or inflammation;
- Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- Uncontrolled diabetes mellitus
- 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);
- Severe co-existing morbidities having a life expectancy of less than 30 days;
- Currently involved in any other investigational clinical Studies;
- Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
- Extreme morbid obesity (BMI greater than 45 kg/m2)
- Patients presenting with Ascites

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837601
Contact: Michelle R Jacobs, MA | 330-543-4969 | mjacobs@akronchildrens.org | |
Contact: Sarah E Pfeiffer, MA | 330-543-1327 | spfeiffer@akronchildrens.org |
United States, Ohio | |
Children's Hospital Medical Center of Akron | |
Akron, Ohio, United States, 44308 | |
Contact: Michelle R Jacobs, MA 330-543-4969 mjacobs@akronchildrens.org | |
Contact: Sarah E Pfeiffer, MA 330-543-1327 spfeiffer@akronchildrens.org |
Principal Investigator: | Todd Ponsky, MD | Akron Children's Hospital |
Responsible Party: | Todd Ponsky, MD, Akron Children's Hospital |
ClinicalTrials.gov Identifier: | NCT02837601 |
Other Study ID Numbers: |
PRESSURE |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | July 13, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Laparoscopic surgical procedures Shoulder Pain Abdominal Pain Pediatrics |
Shoulder Pain Pneumoperitoneum Arthralgia Joint Diseases Musculoskeletal Diseases |
Pain Neurologic Manifestations Peritoneal Diseases Digestive System Diseases |