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NCT04757025 Clinical Trial

Intraoperative Electrical Impedance Tomography in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy.

Obese Clinical Trial

Official title:
Optimization of Intraoperative Ventilation Guided by Electrical Impedance Tomography in Combination With Oxygen Saturation by Pulse Oximetry (SpO2) Versus SpO2 Alone in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy: Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04757025
Other study ID # RS1452/20(2443)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date June 1, 2022

Study information
Verified date February 2021
Source Regina Elena Cancer Institute
Contact Ester Forastiere, MD
Phone +390652662995
Email forastiere@ifo.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of our study will be verify a possible improvement in arterial oxygenation in the obese patient undergoing robotic-assisted radical prostatectomy if the ventilation will be guided by electrical impedance tomography rather than peripheral saturation alone.

Recruitment information / eligibility
Status Recruiting
Enrollment 54
Est. completion date June 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients scheduled for laparoscopic radical prostatectomy - BMI = 30 kg/m2 Exclusion Criteria: - surgery duration < 2 hours - history of lung diseases

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Electrical Impedance Tomography
In 27 patients ventilation will be guided with an Electrical Impedance Tomography system
• Peripheral arterial Saturation
The ventilation of 27 patients will be guided by Peripheral arterial Saturation alone

Locations
Country Name City State
Italy Regina Elena Cancer Institute Rome RM

Sponsors (1)
Lead Sponsor Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio The primary outcome will be the ratio of arterial oxygen pressure and the fraction of inspired oxygen (pO2 / FiO2 ratio) at the end of the intervention, detected by blood gas analysis. 16 months
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