ObeseNCT04757025
Intraoperative Electrical Impedance Tomography in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy.
A study testing Electrical Impedance Tomography and Peripheral arterial Saturation in people with Obese, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obese
- What is being tested?
- Electrical Impedance Tomography and Peripheral arterial Saturation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for laparoscopic radical prostatectomy
- BMI ≥ 30 kg/m2
Who cannot join
- surgery duration < 2 hours
- history of lung diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Regina Elena Cancer Institute
Rome, RM, 00144
Forastiere Ester, 00390652662994, forastiere@ifo.it
Claudia Claroni, MD
About this study
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
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.
- Conditions
- Obese
- Being tested
- Electrical Impedance Tomography, Peripheral arterial Saturation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance TomographyDevice
In 27 patients ventilation will be guided with an Electrical Impedance Tomography system
Peripheral arterial SaturationDevice
The ventilation of 27 patients will be guided by Peripheral arterial Saturation alone
| Study group | Role | What they receive |
|---|---|---|
| Electrical Impedance Tomography | Experimental | patient monitored by Electrical Impedance Tomography Receives: Device: Electrical Impedance Tomography |
| Peripheral arterial Saturation | Active comparator | patient monitored by Peripheral arterial Saturation alone Receives: Device: Peripheral arterial Saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, MD, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757025
- Sponsor's protocol ID
- RS1452/20(2443)
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04757025
- Acronym / sponsor ID
- RS1452/20(2443)
- Conditions
- Obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Impedance Tomography | Experimental | Device: Electrical Impedance Tomographypatient monitored by Electrical Impedance Tomography |
| Peripheral arterial Saturation | Active comparator | Device: Peripheral arterial Saturationpatient monitored by Peripheral arterial Saturation alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for laparoscopic radical prostatectomy
- BMI ≥ 30 kg/m2
Key exclusion criteria (2 listed)
- surgery duration < 2 hours
- history of lung diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance TomographyIn 27 patients ventilation will be guided with an Electrical Impedance Tomography system | Device | Electrical Impedance Tomography |
| Peripheral arterial SaturationThe ventilation of 27 patients will be guided by Peripheral arterial Saturation alone | Device | Peripheral arterial Saturation |
Primary outcome
The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
Related trials for Obese
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography and Peripheral arterial Saturation in people with Obese, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ester Forastiere, MD (+390652662995, forastiere@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.