Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Prostatic Neoplasms

Pneumoperitoneum

Peritoneal Diseases

Gastrointestinal Diseases

This group receives the AirSeal System for intraoperative insufflation.

This group receives the Standard Endopath Trocar for intraoperative insufflation.

To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.

AirSeal System

Standard Endopath

Ronney Abaza, MD,FACS

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

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.

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

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.

The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure

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 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)

The amount of dissolved oxygen (PaO2) in arterial blood (mmHg).

The number of times the anesthesiologist had to adjust ventilator settings

Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average

SurgiQuest, Inc.

OhioHealth

All patients were assessed through discharge for device malfunction, wound infection, urine output, nausea, and vomiting.

This group receives the AirSeal System for intraoperative insufflation.

AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity

Race/Ethnicity, Customized

United States

Region of Enrollment

Data were not recorded for one patient in the Standard Endopath group.

Body Mass Index (BMI)

Data not recorded for one participant in the Standard Endopath group

Preoperative hemoglobin

Preoperative creatinine

Dr. Oscar Martinez

Data were missing for one participant in each group.

Intraoperative Pneumoperitoneal Pressure (mmHg)

Baseline

60 minutes

End of procedure

Data were missing for one participant in the Standard Endopath group at all time points. Data were missing for two AirSeal participants at baseline and 60 minutes, and for one AirSeal participant at end of procedure.

Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).

60 Minutes

Missing data for five, five, and seven AirSeal participants at baseline, 60 minutes, and end of procedure, respectively. Missing data for five, four, and four participants at baseline, 60 minutes, and end of procedure, respectively.

End-tidal Carbon Dioxide Pressure (mmHg)

Missing data for eight, six, and nine AirSeal participants at baseline, 60 minutes, and end of procedure, respectively. Missing data for eight, seven, and eight Standard Endopath participants at baseline, 60 minutes, and end of procedure, respectively.

Carbon Dioxide Elimination (mmHg)

Data missing for one Standard Endopath participant at all time points. Data missing for two AirSeal participants at baseline and 60 minutes, and one AirSeal participant at end of procedure.

Intraoperative Arterial Blood Gas Oxygen (mmHg).

Missing data for two participants in the AirSeal group and one participant in the Standard Endopath group

Number of Ventilator Interventions

Missing data for one participant in the AirSeal group and one participant in the Standard Endopath group

Procedure Time (Minutes)

Below Average

Average

Above Average

Missing data for one participant in the AirSeal group and two participants in the Standard Endopath group

Spots Global Cancer Trial Database for airseal system