Trials / Completed
CompletedNCT02114164
Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies
A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- OhioHealth · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AirSeal System | To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar. |
| DEVICE | Standard Endopath | This group receives the Standard Endopath Trocar for intraoperative insufflation. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2018-05-03
- Completion
- 2019-07-15
- First posted
- 2014-04-15
- Last updated
- 2021-11-26
- Results posted
- 2021-11-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02114164. Inclusion in this directory is not an endorsement.