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A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSealĀ® 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOW AIS Pressure AirSeal® | Other | AIS with an insufflation pressure target of 9mmHg ±1mmHg |
|
| HIGH AIS Pressure AirSeal® | Other | AIS with an insufflation pressure target of 15mmHg ±1mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirSealĀ® Insufflation System (AIS) | Device | The AirSealĀ® System consists of an insufflation, filtration, and recirculation system (AirSealĀ® iFS), a triple lumen filtered tube set, and a valve free trocar (AirSealĀ® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSealĀ® 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 (AirSealĀ® iFS) designed specifically for the AirSealĀ® Access Port to create and maintain the pressure barrier. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative shoulder pain | 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. | Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity and trend | 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. | Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle R Jacobs, MA | Contact | 330-543-4969 | mjacobs@akronchildrens.org | |
| Sarah E Pfeiffer, MA | Contact | 330-543-1327 | spfeiffer@akronchildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Todd Ponsky, MD | Akron Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19370662 | Background | Gurusamy KS, Samraj K, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006930. doi: 10.1002/14651858.CD006930.pub2. | |
| 24503370 | Background | Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16. |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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|
| Pressure stability | Stability of intra-abdominal pressure | During procedure |
| Ease of anesthesia management | Excessively high peak and/or mean airway pressures. Anesthesiologist reported difficulty with ventilation. | During procedure |
| Length of recovery room stay | A measure of time the patient spends in the post-anesthesia recovery area | Post-anesthesia care unit (PACU) discharge, up to 24 hours. |
| Length of Stay (LOS) | 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. | Until the time of hospital discharge, up to 10 days. |
| Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs? | During hospital stay up to 30 days |
| Rate of device-related events | During procedure |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |