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Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

Primary Purpose

Prostate Cancer, Pneumoperitoneum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AirSeal System
Standard Endopath
Sponsored by
OhioHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring AirSeal, Trocar, Carbon Dioxide Exchange and Absorption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dublin Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AirSeal System

Standard Endopath

Arm Description

This group receives the AirSeal System for intraoperative insufflation.

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Outcomes

Primary Outcome Measures

Intraoperative Pneumoperitoneal Pressure (mmHg)
Pneumoperitoneal pressure is the pressure exerted by air or gas in the abdominal (peritoneal) cavity. As the amount of air/gas increases, the pressure (mmHg) increases. The highest pressure that occurred during the procedure was compared between groups.

Secondary Outcome Measures

Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).
The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure
End-tidal Carbon Dioxide Pressure (mmHg)
End-tidal carbon dioxide pressure is the partial pressure of carbon dioxide at the end of exhalation. Normal value is 35-45 mmHg.
Carbon Dioxide Elimination (mmHg)
Carbon dioxide elimination was calculated using end-tidal carbon dioxide pressure (EtCO2), tidal volume, respiratory rate, barometric pressure (pB = 760mm Hg), partial pressure of water vapor (PH2O = 13 mm Hg), and patient weight (kg)
Intraoperative Arterial Blood Gas Oxygen (mmHg).
The amount of dissolved oxygen (PaO2) in arterial blood (mmHg).
Number of Ventilator Interventions
The number of times the anesthesiologist had to adjust ventilator settings
Procedure Time (Minutes)
The duration of the procedure
Smoke Evacuation Quality
Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average

Full Information

First Posted
January 10, 2014
Last Updated
October 28, 2021
Sponsor
OhioHealth
Collaborators
SurgiQuest, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02114164
Brief Title
Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies
Official Title
A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth
Collaborators
SurgiQuest, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.
Detailed Description
The primary observation to be made is the level of carbon dioxide 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, carbon dioxide will be absorbed in lower levels when compared to the standard of care systems in which fluctuations in intra-peritoneum pressure are seen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Pneumoperitoneum
Keywords
AirSeal, Trocar, Carbon Dioxide Exchange and Absorption

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AirSeal System
Arm Type
Active Comparator
Arm Description
This group receives the AirSeal System for intraoperative insufflation.
Arm Title
Standard Endopath
Arm Type
Active Comparator
Arm Description
This group receives the Standard Endopath Trocar for intraoperative insufflation.
Intervention Type
Device
Intervention Name(s)
AirSeal System
Other Intervention Name(s)
Valve-free Trocar
Intervention Description
To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.
Intervention Type
Device
Intervention Name(s)
Standard Endopath
Other Intervention Name(s)
Endopath Trocar
Intervention Description
This group receives the Standard Endopath Trocar for intraoperative insufflation.
Primary Outcome Measure Information:
Title
Intraoperative Pneumoperitoneal Pressure (mmHg)
Description
Pneumoperitoneal pressure is the pressure exerted by air or gas in the abdominal (peritoneal) cavity. As the amount of air/gas increases, the pressure (mmHg) increases. The highest pressure that occurred during the procedure was compared between groups.
Time Frame
Through end of procedure, an average of 156 minutes
Secondary Outcome Measure Information:
Title
Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).
Description
The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure
Time Frame
Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Title
End-tidal Carbon Dioxide Pressure (mmHg)
Description
End-tidal carbon dioxide pressure is the partial pressure of carbon dioxide at the end of exhalation. Normal value is 35-45 mmHg.
Time Frame
Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Title
Carbon Dioxide Elimination (mmHg)
Description
Carbon dioxide elimination was calculated using end-tidal carbon dioxide pressure (EtCO2), tidal volume, respiratory rate, barometric pressure (pB = 760mm Hg), partial pressure of water vapor (PH2O = 13 mm Hg), and patient weight (kg)
Time Frame
Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Title
Intraoperative Arterial Blood Gas Oxygen (mmHg).
Description
The amount of dissolved oxygen (PaO2) in arterial blood (mmHg).
Time Frame
Baseline, 60 minutes, and end of procedure, an average of 156 minutes
Title
Number of Ventilator Interventions
Description
The number of times the anesthesiologist had to adjust ventilator settings
Time Frame
Through end of procedure, an average of 156 minutes
Title
Procedure Time (Minutes)
Description
The duration of the procedure
Time Frame
Through end of procedure, an average of 156 minutes
Title
Smoke Evacuation Quality
Description
Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average
Time Frame
Through end of procedure, an average of 156 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronney Abaza, MD,FACS
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dublin Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33349135
Citation
Abaza R, Martinez O, Murphy C. Randomized Controlled Comparison of Valveless Trocar (AirSeal) vs Standard Insufflator with Ultralow Pneuomoperitoneum During Robotic Prostatectomy. J Endourol. 2021 Jul;35(7):1020-1024. doi: 10.1089/end.2020.1025. Epub 2021 Jan 21.
Results Reference
derived

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Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

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