NCT04757025

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 8, 2021

Last Update Submit

February 15, 2021

Conditions

Obese

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Electrical Impedance Tomography

EXPERIMENTAL

patient monitored by Electrical Impedance Tomography

Device: Electrical Impedance Tomography

Peripheral arterial Saturation

ACTIVE COMPARATOR

patient monitored by Peripheral arterial Saturation alone

Device: Peripheral arterial Saturation

Interventions

Electrical Impedance TomographyDEVICE

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

Electrical Impedance Tomography
Peripheral arterial SaturationDEVICE

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

Peripheral arterial Saturation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • surgery duration \< 2 hours
  • history of lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Elena Cancer Institute

Rome, RM, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ester Forastiere, MD

CONTACT

+390652662995forastiere@ifo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Anaestesiology and Critical Care

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 16, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

June 1, 2022

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

IT(1)