ClinicalTrials.gg
Status unknownNCT04194177EIT_ROBOUpdated Dec 11, 2019

Evaluation of Thoracic Impedance Tomography During Robotic Surgery

An interventional study of mechanical ventilation during robotic surgery in Atelectasis, sponsored by Federico II University. Status unknown at 1 site in Italy. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Federico II University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jan 2017, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
Male
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Study summary

the evaluation of distribution of mechanical ventilation during robotic surgery

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Conditions studied

  • Atelectasis

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03

In context

Pulmonary Atelectasis

308 studies on the registry are indexed under Pulmonary Atelectasis; 79 are open to participants now.

This study's planned enrollment of 40 is below the median of 61 across 226 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Federico II University is the lead sponsor of 365 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age>18
  • informed consent
  • robotic surgery

Exclusion criteria

Exclusion Criteria:

  • age\<18
  • no consent for the study
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    protective

    Other: mechanical ventilation during robotic surgery

  • Active comparator
    conventional

    Other: mechanical ventilation during robotic surgery

Interventions

  • Othermechanical ventilation during robotic surgery

    protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg

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What researchers measure

Primary outcomes

  1. distribution of tidal volume

    Time frame: at the end of surgery

Secondary outcomes

  1. driving pressure

    Time frame: at the end of surgery

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Study locations

1 of 1 sites recruiting
  • University of Naples Federico II department of Anesthesia and Critical Care
    Naples, 80100, Italy
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04194177
Responsible party
Maria Vargas (resercher, Federico II University) — Principal investigator
First posted
Dec 11, 2019
Start date
Jan 2017
Primary completion
Jan 2019
Completion
Feb 2020 (estimated)
Last update
Dec 11, 2019

Study contacts

maria vargas, MD
Contact
vargas.maria82@gmail.com
+393396876440

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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