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Completed

NCT Number: NCT02114164

Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

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

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Key information

Conditions

Prostate Cancer Digestive System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Peritoneal Diseases Pneumoperitoneum Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dublin Methodist Hospital

Columbus, Ohio, 43016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AirSeal System

Device

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

Other names: Valve-free Trocar

Standard Endopath

Device

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Other names: Endopath Trocar

Primary outcomes

  1. Intraoperative Pneumoperitoneal Pressure (mmHg)

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

    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.

Secondary outcomes

  1. Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).

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

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

  2. End-tidal Carbon Dioxide Pressure (mmHg)

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

    End-tidal carbon dioxide pressure is the partial pressure of carbon dioxide at the end of exhalation. Normal value is 35-45 mmHg.

  3. Carbon Dioxide Elimination (mmHg)

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

    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)

  4. Intraoperative Arterial Blood Gas Oxygen (mmHg).

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

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

  5. Number of Ventilator Interventions

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

    The number of times the anesthesiologist had to adjust ventilator settings

  6. Procedure Time (Minutes)

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

    The duration of the procedure

  7. Smoke Evacuation Quality

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

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

Sponsors and collaborators

Lead sponsor

OhioHealth

Other

Collaborators

  • SurgiQuest, Inc.

Registry information

Official study title

A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 15, 2014
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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