search
Back to results

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

Primary Purpose

Obese

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Electrical Impedance Tomography
Peripheral arterial Saturation
Sponsored by
Regina Elena Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • surgery duration < 2 hours
  • history of lung diseases

Sites / Locations

  • Regina Elena Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrical Impedance Tomography

Peripheral arterial Saturation

Arm Description

patient monitored by Electrical Impedance Tomography

patient monitored by Peripheral arterial Saturation alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2021
Last Updated
February 15, 2021
Sponsor
Regina Elena Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04757025
Brief Title
Intraoperative Electrical Impedance Tomography in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy.
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrical Impedance Tomography
Arm Type
Experimental
Arm Description
patient monitored by Electrical Impedance Tomography
Arm Title
Peripheral arterial Saturation
Arm Type
Active Comparator
Arm Description
patient monitored by Peripheral arterial Saturation alone
Intervention Type
Device
Intervention Name(s)
Electrical Impedance Tomography
Intervention Description
In 27 patients ventilation will be guided with an Electrical Impedance Tomography system
Intervention Type
Device
Intervention Name(s)
Peripheral arterial Saturation
Intervention Description
The ventilation of 27 patients will be guided by Peripheral arterial Saturation alone
Primary Outcome Measure Information:
Title
The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio
Description
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.
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for laparoscopic radical prostatectomy BMI ≥ 30 kg/m2 Exclusion Criteria: surgery duration < 2 hours history of lung diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ester Forastiere, MD
Phone
+390652662995
Email
forastiere@ifo.it
Facility Information:
Facility Name
Regina Elena Cancer Institute
City
Rome
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Forastiere Ester
Phone
00390652662994
Email
forastiere@ifo.it
First Name & Middle Initial & Last Name & Degree
Claudia Claroni, MD
First Name & Middle Initial & Last Name & Degree
Marco Covotta, MD
First Name & Middle Initial & Last Name & Degree
Lorenzo Fabrocile, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs