Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AirSeal® Insufflation System (AIS).
- Who it may be relevant to
- Registry conditions: Shoulder Pain. Basic parameters: up to 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed 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.
Interventions
- 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 ut
Primary outcome measures
- 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.]
Secondary outcome measures (7)
- 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.]
- Pressure stability [Time frame: During procedure]
- Ease of anesthesia management [Time frame: During procedure]
- Length of recovery room stay [Time frame: Post-anesthesia care unit (PACU) discharge, up to 24 hours.]
- Length of Stay (LOS) [Time frame: Until the time of hospital discharge, up to 10 days.]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Children's Hospital Medical Center of Akron — Akron
Publications
- 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. PMID 19370662
- 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. PMID 24503370
Identifiers
NCT: NCT02837601 · PRESSURE