AirSeal®Insufflation Trocar/CO2 Absorption Study

August 20, 2021 updated by: Columbia University

A Comparison of CO2 Absorption During Gynecologic Laparoscopy Using the AirSeal® Valveless Trocar System Versus Standard Insufflation Trocars at Intra-abdominal Pressures of 10 mmHg and 15 mmHg - a Randomized Controlled Trial

The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg.

The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Three main factors affect patients' cardiopulmonary status during gynecologic laparoscopy: 1) degree of Trendelenburg tilt (25 - 30°), 2) carbon dioxide (CO2) absorption and 3) increased intra-abdominal pressure (10 -20 mmHg). Slight modifications to any or all of these three factors can lead to a significant decrease in morbidity.

The AirSeal® valveless trocar system reduces CO2 absorption when compared to standard trocars during renal laparoscopy. Also, use of this trocar system provides a more stable intra-abdominal pressure when compared to standard trocars, a feature that could possibly allow for laparoscopic surgery to be performed at lower intra-abdominal pressures.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any woman ≥ 18 years of age undergoing a gynecologic laparoscopic procedure
  • Able to understand the consenting process and willing to participate in study

Exclusion Criteria:

  • Patient unable to undergo laparoscopic procedure due to size of pathology or medical comorbidities
  • Emergent surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard trocar/ IAP 15 mmHg
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Device: Standard trocar
A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
Active Comparator: Standard trocar/ IAP 10 mmHg
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Device: Standard trocar
A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
Active Comparator: AirSeal trocar/ IAP 15 mmHg
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Device: AirSeal trocar
The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
Active Comparator: AirSeal trocar/ IAP 10 mmHg
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Device: AirSeal trocar
The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg
Time Frame: 15 minutes & 60 minutes from surgery start time
This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases < 60 minutes, the CO2 absorption rate at 15 minutes will be used.
15 minutes & 60 minutes from surgery start time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
Time Frame: At the end of surgery (approximately 1 hour)
Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy.
At the end of surgery (approximately 1 hour)
Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars
Time Frame: At the end of surgery (approximately 1 hour)
Anesthesia Questionnaire (0 "no problem" - 2 "very problematic) is designed to evaluate the the level of difficulty in maintaining adequate end-tidal CO2 (etCO2).
At the end of surgery (approximately 1 hour)
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
Time Frame: 4 to 6 hours, and 12 to 23 hours following surgery
Visual Analog Scale (VAS) Pain Score (0 "no pain" - 10 "worst pain") is designed to evaluate the level of pain post-surgery.
4 to 6 hours, and 12 to 23 hours following surgery
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg
Time Frame: 15 minutes & 60 minutes from surgery start time
This outcome is measured by calculating the CO2 elimination rate.
15 minutes & 60 minutes from surgery start time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

SurgiQuest, Inc.

Investigators

  • Principal Investigator: Timothy Ryntz, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAQ6474

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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