Clinical Trials Directory

Trials / Completed

CompletedNCT03704038

Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
University Hospital Dubrava · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPEEP levelPatients will have variable PEEP levels and will be monitored

Timeline

Start date
2018-06-01
Primary completion
2018-11-01
Completion
2018-11-01
First posted
2018-10-12
Last updated
2019-04-17

Locations

1 site across 1 country: Croatia

Source: ClinicalTrials.gov record NCT03704038. Inclusion in this directory is not an endorsement.