AtelectasisEIT_ROBONCT04194177
Evaluation of Thoracic Impedance Tomography During Robotic Surgery
A study testing mechanical ventilation during robotic surgery in people with Atelectasis, run by Federico II University at 1 site in Italy.
Trial summary
the evaluation of distribution of mechanical ventilation during robotic surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Atelectasis
- What is being tested?
- mechanical ventilation during robotic surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to Feb 2020
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18
- informed consent
- robotic surgery
Who cannot join
- age<18
- no consent for the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Naples Federico II department of Anesthesia and Critical Care
Naples, 80100
Maria Vargas, MD, vargas.maria82@gmail.com
About this study
Official title: Evaluation of Two Types of Mechanical Ventilation During Robotic Surgery With the Thoracic Impedance Tomography
the evaluation of distribution of mechanical ventilation during robotic surgery
- Conditions
- Atelectasis
- Being tested
- mechanical ventilation during robotic surgery
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilation during robotic surgeryOther
protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| protective | Experimental | Not described Receives: Other: mechanical ventilation during robotic surgery |
| conventional | Active comparator | Not described Receives: Other: mechanical ventilation during robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
distribution of tidal volume
Measured: at the end of surgery
Secondary outcomes (1)
driving pressure
Measured: at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study startJan 2017
- Primary completionJan 2019
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Vargas, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194177
- Sponsor's protocol ID
- EIT_OR
- Acronym
- EIT_ROBO
- Status last verified
- Dec 2019
- First submitted
- 8 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Buonanno P, Marra A, Iacovazzo C, Merola R, De Siena AU, Servillo G, Vargas M. Electric impedance tomography and protective mechanical ventilation in elective robotic-assisted laparoscopy surgery with steep Trendelenburg position: a randomized controlled study. Sci Rep. 2023 Feb 16;13(1):2753. doi: 10.1038/s41598-023-29860-x.
PubMed 36797394
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Types of Mechanical Ventilation During Robotic Surgery With the Thoracic Impedance Tomography
- ClinicalTrials.gov ID
- NCT04194177
- Acronym / sponsor ID
- EIT_ROBO / EIT_OR
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 11 Dec 2019 (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 evaluation of distribution of mechanical ventilation during robotic surgery
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protective | Experimental | Other: mechanical ventilation during robotic surgery |
| conventional | Active comparator | Other: mechanical ventilation during robotic surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age>18
- informed consent
- robotic surgery
Key exclusion criteria (2 listed)
- age<18
- no consent for the study
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 |
|---|---|---|
| mechanical ventilation during robotic surgeryprotective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg | Other | conventional, protective |
Primary outcome
distribution of tidal volume
Time frame: at the end of surgery
1 secondary outcome
driving pressure
Time frame: at the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Derived from this study: PubMed 36797394Buonanno P, Marra A, Iacovazzo C, Merola R, De Siena AU, Servillo G, Vargas M. Electric impedance tomography and protective mechanical ventilation in elective robotic-assisted laparoscopy surgery with steep Trendelenburg position: a randomized controlled study. Sci Rep. 2023 Feb 16;13(1):2753. doi: 10.1038/s41598-023-29860-x.
- Individual participant dataSharing planned: Undecided
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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 mechanical ventilation during robotic surgery in people with Atelectasis, run by Federico II University 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 3 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 11 Dec 2019. 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 maria vargas, MD (+393396876440, vargas.maria82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distribution of tidal volume (time frame: at the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194177, which also lists 1 linked publication.
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 11 Dec 2019.