Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure
ConditionShoulder Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorAkron Children's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- AirSeal® Insufflation System (AIS)
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov