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

Not Applicable

• Conditions: Obese
• Interventions: Device: Electrical Impedance Tomography; Device: Peripheral arterial Saturation

• Registration Number: NCT04757025
• Lead Sponsor: Regina Elena Cancer Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-01
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16
• Primary Completion: 2022-02-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients scheduled for laparoscopic radical prostatectomy
• BMI ≥ 30 kg/m2

Exclusion Criteria

• surgery duration < 2 hours
• history of lung diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical Impedance Tomography	Electrical Impedance Tomography	patient monitored by Electrical Impedance Tomography
Peripheral arterial Saturation	Peripheral arterial Saturation	patient monitored by Peripheral arterial Saturation alone

Primary Outcome Measures

Name	Time	Method
The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio	16 months	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.

Trial Locations

Locations (1)

Regina Elena Cancer Institute; 🇮🇹 Rome, RM, Italy