Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

OhioHealth109 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

109

Conditions

Prostate Cancer Pneumoperitoneum

Interventions

AirSeal SystemDEVICE

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

Standard EndopathDEVICE

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dublin Methodist Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Through end of procedure, an average of 156 minutes

Secondary Outcomes

Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).

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

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.

Time frame: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes

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)

Time frame: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes

Intraoperative Arterial Blood Gas Oxygen (mmHg).

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

Time frame: Baseline, 60 minutes, and end of procedure, an average of 156 minutes

Number of Ventilator Interventions

The number of times the anesthesiologist had to adjust ventilator settings

Data from ClinicalTrials.gov

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