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

Part of paid clinical trials in Akron, Ohio.

Sponsor
Akron Children's Hospital
Study ID
NCT02837601
Status
Not Yet Recruiting

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Conditions

  • Shoulder Pain

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • AirSeal® Insufflation System (AIS) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2021
Status verified
Jul 2020
Primary completion
Nov 30, 2025
Completion
Nov 30, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Medical Center of AkronAkronOhio44308
Michelle R Jacobs, MA
[email protected]
330-543-4969
Sarah E Pfeiffer, MA
[email protected]
330-543-1327

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By research site
Children's Hospital Medical Center of Akron· Akron, OH

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