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
About this trial
This is an interventional diagnostic trial for Atelectasis
Eligibility Criteria
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
NCT ID
NCT04194177
First Posted
December 8, 2019
Last Updated
December 8, 2019
Sponsor
Federico II University
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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