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Evaluation of Thoracic Impedance Tomography During Robotic Surgery (EIT_ROBO)

Primary Purpose

Atelectasis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mechanical ventilation during robotic surgery
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atelectasis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age>18
  • informed consent
  • robotic surgery

Exclusion Criteria:

  • age<18
  • no consent for the study

Sites / Locations

  • University of Naples Federico II department of Anesthesia and Critical CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

protective

conventional

Arm Description

Outcomes

Primary Outcome Measures

distribution of tidal volume

Secondary Outcome Measures

driving pressure

Full Information

First Posted
December 8, 2019
Last Updated
December 8, 2019
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT04194177
Brief Title
Evaluation of Thoracic Impedance Tomography During Robotic Surgery
Acronym
EIT_ROBO
Official Title
Evaluation of Two Types of Mechanical Ventilation During Robotic Surgery With the Thoracic Impedance Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
the evaluation of distribution of mechanical ventilation during robotic surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
protective
Arm Type
Experimental
Arm Title
conventional
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
mechanical ventilation during robotic surgery
Intervention Description
protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg
Primary Outcome Measure Information:
Title
distribution of tidal volume
Time Frame
at the end of surgery
Secondary Outcome Measure Information:
Title
driving pressure
Time Frame
at the end of surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age>18 informed consent robotic surgery Exclusion Criteria: age<18 no consent for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
maria vargas, MD
Phone
+393396876440
Email
vargas.maria82@gmail.com
Facility Information:
Facility Name
University of Naples Federico II department of Anesthesia and Critical Care
City
Naples
ZIP/Postal Code
80100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Vargas, MD
Email
vargas.maria82@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluation of Thoracic Impedance Tomography During Robotic Surgery

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