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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04757025
Enrollment
54
Registered
2021-02-16
Start date
2021-02-01
Completion date
2022-06-01
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese

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.

Interventions

DEVICEElectrical Impedance Tomography

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

DEVICEPeripheral arterial Saturation

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

Sponsors

Regina Elena Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio16 monthsThe 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.

Countries

Italy

Contacts

Primary ContactEster Forastiere, MD
forastiere@ifo.it+390652662995

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026