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

NCT ID: NCT04757025

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-06-01

Brief Summary

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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

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Conditions

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Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Electrical Impedance Tomography

patient monitored by Electrical Impedance Tomography

Group Type EXPERIMENTAL

Electrical Impedance Tomography

Intervention Type DEVICE

In 27 patients ventilation will be guided with an Electrical Impedance Tomography system

Peripheral arterial Saturation

patient monitored by Peripheral arterial Saturation alone

Group Type ACTIVE_COMPARATOR

Peripheral arterial Saturation

Intervention Type DEVICE

The ventilation of 27 patients will be guided by Peripheral arterial Saturation alone

Interventions

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Electrical Impedance Tomography

In 27 patients ventilation will be guided with an Electrical Impedance Tomography system

Intervention Type DEVICE

Peripheral arterial Saturation

The ventilation of 27 patients will be guided by Peripheral arterial Saturation alone

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* surgery duration \< 2 hours
* history of lung diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Ester Forastiere, MD

Head of Department of Anaestesiology and Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Regina Elena Cancer Institute

Rome, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Ester Forastiere, MD

Role: CONTACT

+390652662995

Facility Contacts

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Forastiere Ester

Role: primary

00390652662994

Other Identifiers

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RS1452/20(2443)

Identifier Type: -

Identifier Source: org_study_id

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