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

Primary Purpose

Shoulder Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SurgiQuest AIRSEAL® Insufflation System (AIS)

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Advanced refusal of blood transfusion, if necessary;
Active systemic or cutaneous infection or inflammation;
Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
Uncontrolled diabetes mellitus
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);
Severe co-existing morbidities having a life expectancy of less than 30 days;
Currently involved in any other investigational clinical Studies;
Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
Renal insufficiency (serum creatinine of > 2.5 mg/dl);
Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
Patients presenting with Ascites -

Sites / Locations

South Miami Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

AIS at 9±1mmHg

AIS at 15±1mmHg

Arm Description

Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 9±1mmHg

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

Outcomes

Primary Outcome Measures

Incidence of shoulder pain

Incidence of reported shoulder pain

Secondary Outcome Measures

Full Information

NCT ID

NCT02541448

First Posted

September 1, 2015

Last Updated

November 11, 2019

Sponsor

Cynthia Harris

Collaborators

SurgiQuest, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02541448

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (Actual)

Primary Completion Date

May 18, 2016 (Actual)

Study Completion Date

July 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Cynthia Harris

Collaborators

SurgiQuest, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIS at 9±1mmHg

Arm Type

Active Comparator

Arm Description

Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 9±1mmHg

Arm Title

AIS at 15±1mmHg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

SurgiQuest AIRSEAL® Insufflation System (AIS)

Other Intervention Name(s)

AIS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of shoulder pain

Description

Incidence of reported shoulder pain

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 to 80 years of age; Capable and willing to give informed consent; Acceptable candidate for an elective, non-emergent laparoscopic/robotic surgery; Exclusion Criteria: Advanced refusal of blood transfusion, if necessary; Active systemic or cutaneous infection or inflammation; Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; Uncontrolled diabetes mellitus 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); Severe co-existing morbidities having a life expectancy of less than 30 days; Currently involved in any other investigational clinical Studies; Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; Renal insufficiency (serum creatinine of > 2.5 mg/dl); Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2); Patients presenting with Ascites -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P Diaz, MD

Organizational Affiliation

South Miami Hospital, Miami Floridaa

Official's Role

Principal Investigator

Facility Information:

Facility Name

South Miami Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

12. IPD Sharing Statement

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

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