Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03704038
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2018-09-24
Brief Title:
Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
Sponsor:
University Hospital Dubrava
Organization:
University Hospital Dubrava
Study Overview
Official Title:
Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sevofluraneO2air 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 nondependentdependent 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
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 nondependentdependent 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None