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

• Sponsor: Cynthia Harris (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02541448
• Collaborator: SurgiQuest, Inc. (Industry)
• Enrollment: 119
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.4
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Device: SurgiQuest AIRSEAL® Insufflation System (AIS)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: May 18, 2016
• Actual Study Completion Date: Jul 12, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Miami Hospital	Miami	Florida	United States	33143

Sponsors and Collaborators

• Cynthia Harris
• SurgiQuest, Inc.

Investigators

• Principal Investigator: John P Diaz, MD, South Miami Hospital, Miami Floridaa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cynthia Harris, Director of Clinical Studies, SurgiQuest, Inc.
• ClinicalTrials.gov Identifier: NCT02541448
• Other Study ID Numbers: PRT DD030316
• First Posted: Sep 4, 2015
• Last Update Posted: Nov 13, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Shoulder Pain; Pneumoperitoneum

Study Results

No Results Posted as of Nov 13, 2019