Evaluation of Thoracic Impedance Tomography During Robotic Surgery (EIT_ROBO)

December 8, 2019 updated by: Maria Vargas, Federico II University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • Recruiting
        • University of Naples Federico II department of Anesthesia and Critical Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • age>18
  • informed consent
  • robotic surgery

Exclusion Criteria:

  • age<18
  • no consent for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: protective
Other: mechanical ventilation during robotic surgery
protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg
Active Comparator: conventional
Other: mechanical ventilation during robotic surgery
protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
distribution of tidal volume
Time Frame: at the end of surgery
at the end of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
driving pressure
Time Frame: at the end of surgery
at the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

December 8, 2019

First Submitted That Met QC Criteria

December 8, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 8, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIT_OR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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