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

A

Akron Children's Hospital

Status

Not yet enrolling

Conditions

Shoulder Pain

Treatments

Device: AirSeal® Insufflation System (AIS)

Study type

Interventional

Funder types

Other

Identifiers

NCT02837601
PRESSURE

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 estimated patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

LOW AIS Pressure AirSeal®
Other group
Description:
AIS with an insufflation pressure target of 9mmHg ±1mmHg
Treatment:
Device: AirSeal® Insufflation System (AIS)
HIGH AIS Pressure AirSeal®
Other group
Description:
AIS with an insufflation pressure target of 15mmHg ±1mm
Treatment:
Device: AirSeal® Insufflation System (AIS)

Trial contacts and locations

1

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Central trial contact

Sarah E Pfeiffer, MA; Michelle R Jacobs, MA

Data sourced from clinicaltrials.gov

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