Back to resultsElectrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
Primary Purpose
Mechanical Ventilation, Bioelectrical Impedance
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
PEEP level
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Ventilation focused on measuring PEEP, Electrical impedance tomography, Mechanical ventialtion
Eligibility Criteria
Inclusion Criteria:
- patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position
- signed informed consent form
Exclusion Criteria:
- preexisting moderate to severe obstructive (GOLD score > 1) or restrictive lung disease (FVC < 85%)
- history of organ transplant
- disseminated malignant disease
- pregnancy
Sites / Locations
- University Hospital Dubrava
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
PEEP 5
PEEP 0
PEEP 10
Arm Description
Outcomes
Primary Outcome Measures
Change of nondependent / dependent tidal variation
Measured by EIT
Secondary Outcome Measures
Change of a-A gradient
Measured by ABG analysis
Duration of hospital stay
Between groups
Full Information
NCT ID
NCT03704038
First Posted
September 24, 2018
Last Updated
April 15, 2019
Sponsor
University Hospital Dubrava
1. Study Identification
Unique Protocol Identification Number
NCT03704038
Brief Title
Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
Official Title
Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture.
Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded.
Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI).
Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Bioelectrical Impedance
Keywords
PEEP, Electrical impedance tomography, Mechanical ventialtion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEEP 5
Arm Type
Active Comparator
Arm Title
PEEP 0
Arm Type
Active Comparator
Arm Title
PEEP 10
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
PEEP level
Intervention Description
Patients will have variable PEEP levels and will be monitored
Primary Outcome Measure Information:
Title
Change of nondependent / dependent tidal variation
Description
Measured by EIT
Time Frame
Baseline, 10 and 90 minutes post lateral positioning
Secondary Outcome Measure Information:
Title
Change of a-A gradient
Description
Measured by ABG analysis
Time Frame
Baseline, 10 and 90 minutes post lateral positioning
Title
Duration of hospital stay
Description
Between groups
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position
signed informed consent form
Exclusion Criteria:
preexisting moderate to severe obstructive (GOLD score > 1) or restrictive lung disease (FVC < 85%)
history of organ transplant
disseminated malignant disease
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Šribar, MD, PhD
Organizational Affiliation
Anesthesiologist and Critical Care specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
1000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
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