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

Shoulder Pain Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02837601
Study type Interventional
Source Akron Children's Hospital
Contact Michelle R Jacobs, MA
Phone 330-543-4969
Email mjacobs@akronchildrens.org
Status Not yet recruiting
Phase N/A
Start date March 2021
Completion date November 2027
View Details
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