Clinical trial NCT02837601: Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Pain
Keywords: Laparoscopic surgical procedures
Shoulder Pain
Abdominal Pain
Pediatrics
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 102
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Pediatric subjects (\<21 years of age)
2. \> 20 kg in weight;
3. Capable and willing to provide parental Informed Consent and patient Assent;
4. Acceptable candidate for laparoscopic surgery;

Exclusion Criteria:

1. Active cutaneous infection or inflammation;
2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
3. Uncontrolled diabetes mellitus
4. 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);
5. Severe co-existing morbidities having a life expectancy of less than 30 days;
6. Currently involved in any other investigational clinical Studies;
7. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
8. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
9. Extreme morbid obesity (BMI greater than 45 kg/m2)
10. Patients presenting with Ascites

Primary outcomes:
measure: Post-operative shoulder pain
timeFrame: Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.
Secondary outcomes:
measure: Pain severity and trend
timeFrame: Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days.
measure: Pressure stability
timeFrame: During procedure
measure: Ease of anesthesia management
timeFrame: During procedure
measure: Length of recovery room stay
timeFrame: Post-anesthesia care unit (PACU) discharge, up to 24 hours.
measure: Length of Stay (LOS)
timeFrame: Until the time of hospital discharge, up to 10 days.
measure: Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs?
timeFrame: During hospital stay up to 30 days
measure: Rate of device-related events
timeFrame: During procedure
Other outcomes:
Locations:
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Todd Ponsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.