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

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.

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Device: SurgiQuest AIRSEAL® Insufflation System (AIS)

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 Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • South Miami Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: AIS at 9±1mmHg; Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 9±1mmHg	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.; Other Names: AIS
ACTIVE_COMPARATOR: AIS at 15±1mmHg; Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 15±1mmHg.	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.; Other Names: AIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cynthia Harris
• Collaborators: SurgiQuest, Inc.
• Investigators: Principal Investigator: John P Diaz, MD, South Miami Hospital, Miami Floridaa

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): May 18, 2016
• Study Completion (ACTUAL): July 12, 2018

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (ESTIMATE): September 4, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pneumoperitoneum; Shoulder Pain
• Other Study ID Numbers: PRT DD030316