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

Shoulder Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541448
• Other study ID #: PRT DD030316
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 12, 2018

Study information

• Verified date: November 2019
• Source: SurgiQuest, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 12, 2018
• Est. primary completion date: May 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Pneumoperitoneum
• Shoulder Pain

Intervention

Device:
• SurgiQuest AIRSEAL® Insufflation System (AIS)
The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas (establish and maintain pneumoperitoneum), to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

Locations

Country	Name	City	State
United States	South Miami Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cynthia Harris	SurgiQuest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of shoulder pain	Incidence of reported shoulder pain	participants will be followed for the duration of hospital stay, an expected average of 24 hours