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Study of CO2 Exchange Patterns During Robotic Prostatectomies

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ClinicalTrials.gov Identifier: NCT02114164
Recruitment Status : Active, not recruiting
First Posted : April 15, 2014
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
SurgiQuest, Inc.
Information provided by (Responsible Party):
Ronney Abaza, OhioHealth

Brief Summary:
The AirSeal® System will allow for lower CO2 absorption rates than the Xcel® System. Furthermore, lower variance in pneumoperitoneal pressure will allow for less "over-pressure" events and peritoneal stretch, which may reduce postoperative pain.

Condition or disease Intervention/treatment Phase
Prostate Cancer Pneumoperitoneum Device: AirSeal System Device: Standard Endopath Not Applicable

Detailed Description:
The primary observation to be made is the level of PaCO2 in the arterial blood, specifically when the patient is insufflated and deflated during the surgery. As a result of the consistent pressure that the AirSeal® system maintains, CO2 will be absorbed in lower levels when compared to the standard of care systems in which fluctuations in intra-peritoneum pressure are seen. Therefore, higher pressures will result in higher levels of CO2 exchange in the blood, leading to increased vasodilation and lower pH levels.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies
Study Start Date : August 2016
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AirSeal System
This group receives the AirSeal System for intraoperative insufflation.
Device: AirSeal System
To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.
Other Name: Valve-free Trocar

Active Comparator: Standard Endopath
This group receives the Standard Endopath Trocar for intraoperative insufflation.
Device: Standard Endopath
This group receives the Standard Endopath Trocar for intraoperative insufflation.
Other Name: Endopath Trocar




Primary Outcome Measures :
  1. Intraoperative pneumoperitoneal pressure (mmHg). [ Time Frame: Through Day 1 post-op ]
    Compare the maximum intraoperative pneumoperitoneal pressure (mmHg), smoke evacuation quality (categorical), and overall operative times (minutes) between the conventional and valve-less trocar groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>18
  • Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital

Exclusion Criteria:

  • Age < 18
  • Emergency surgery
  • Ascites
  • BMI>44 or <18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114164


Locations
United States, Ohio
Dublin Methodist Hospital
Columbus, Ohio, United States, 43016
Sponsors and Collaborators
OhioHealth
SurgiQuest, Inc.
Investigators
Principal Investigator: Ronney Abaza, MD,FACS OhioHealth

Responsible Party: Ronney Abaza, Medical Director Robotic Surgery, OhioHealth
ClinicalTrials.gov Identifier: NCT02114164     History of Changes
Other Study ID Numbers: OH1-13-00489
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

Keywords provided by Ronney Abaza, OhioHealth:
AirSeal
Trocar
Carbon Dioxide Exchange and Absorption

Additional relevant MeSH terms:
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases