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

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Device: SurgiQuest AIRSEAL® Insufflation System (AIS)

• Registration Number: NCT02541448
• Lead Sponsor: Cynthia Harris

Brief Summary

This study is designed to evaluate physician preference related to the use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of pneumoperitoneum.

Detailed Description

The objective of this study is to evaluate physician preferences related to use of the SurgiQuest AirSeal Insufflation System (AIS) used at low vs. higher pressures for maintaining pneumoperitoneum during laparoscopic/robotic surgical procedures.

The study is designed and powered to demonstrate superiority of the AIS used at low insufflation pressure (9±mmHg ±1mmHg) vs higher pressure (15mmHg ±1mmHg) in relation to a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9±1mmHg) or to AIS with an insufflation target pressure of 15±1mmHg.

Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, procedure time, the number of procedure interruptions, 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/robotic surgery.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Primary Completion: 2016-05-18
• Study Completion: 2018-07-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

1. 18 to 80 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, non-emergent laparoscopic/robotic surgery;

Exclusion Criteria

1. Advanced refusal of blood transfusion, if necessary;
2. Active systemic or cutaneous infection or inflammation;
3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
4. Uncontrolled diabetes mellitus
5. Known, significant history of bleeding diathesis, coagulopathy, Von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
6. Severe co-existing morbidities having a life expectancy of less than 30 days;
7. Currently involved in any other investigational clinical Studies;
8. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
9. Renal insufficiency (serum creatinine of > 2.5 mg/dl);
10. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
11. Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
12. Patients presenting with Ascites -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIS at 15±1mmHg	SurgiQuest AIRSEAL® Insufflation System (AIS)	Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 15±1mmHg.
AIS at 9±1mmHg	SurgiQuest AIRSEAL® Insufflation System (AIS)	Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 9±1mmHg

Primary Outcome Measures

Name	Time	Method
Incidence of shoulder pain	participants will be followed for the duration of hospital stay, an expected average of 24 hours	Incidence of reported shoulder pain

Trial Locations

Locations (1)

South Miami Hospital; 🇺🇸 Miami, Florida, United States