N/A
N=100
Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies
Prostate Cancer · Pneumoperitoneum
Bottom Line
View on ClinicalTrials.gov: NCT02114164 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Intraoperative Pneumoperitoneal Pressure (mmHg) — 7.9; 9.9 mmHg — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AirSeal System (Device); Standard Endopath (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- OhioHealth
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Pneumoperitoneal Pressure (mmHg) |
7.9; 9.9 | <0.001 sig |
| SECONDARY Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). |
39.5; 39.2; 41.5; 41.2; 45.1; 44.1 | 0.39 |
| SECONDARY End-tidal Carbon Dioxide Pressure (mmHg) |
31.47; 29.96; 32.80; 30.96; 34.77; 34.17 | 0.13 |
| SECONDARY Carbon Dioxide Elimination (mmHg) |
3.15; 3.28; 3.24; 3.28; 3.04; 3.11 | 0.42 |
| SECONDARY Intraoperative Arterial Blood Gas Oxygen (mmHg). |
361.9; 364.3; 283.9; 294; 286.5; 290.2 | 0.88 |
| SECONDARY Number of Ventilator Interventions |
0.69; 0.66 | 0.41 |
| SECONDARY Procedure Time (Minutes) |
158.6; 153.0 | 0.09 |
| SECONDARY Smoke Evacuation Quality |
4; 16; 25; 18; 20; 14 | <0.001 sig |
Summary
The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.
Eligibility Criteria
Inclusion Criteria
- Age>18
- Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital
Exclusion Criteria
- Age 44 or <18
Data sourced from ClinicalTrials.gov (NCT02114164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.