Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

OhioHealth

Status: Completed

Conditions: Pneumoperitoneum; Prostate Cancer

Treatments: Device: Standard Endopath; Device: AirSeal System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02114164

OH1-13-00489

Details and patient eligibility

About

The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.

Full 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.

Enrollment: 109 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 2 patient groups

AirSeal System

Active Comparator group

Description:

This group receives the AirSeal System for intraoperative insufflation.

Treatment:

Device: AirSeal System

Standard Endopath

Active Comparator group

Description:

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Treatment:

Device: Standard Endopath