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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03704038
Enrollment
33
Registered
2018-10-12
Start date
2018-06-01
Completion date
2018-11-01
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioelectrical Impedance, Mechanical Ventilation

Keywords

PEEP, Electrical impedance tomography, Mechanical ventialtion

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.

Interventions

PROCEDUREPEEP level

Patients will have variable PEEP levels and will be monitored

Sponsors

University Hospital Dubrava
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of nondependent / dependent tidal variationBaseline, 10 and 90 minutes post lateral positioningMeasured by EIT

Secondary

MeasureTime frameDescription
Change of a-A gradientBaseline, 10 and 90 minutes post lateral positioningMeasured by ABG analysis
Duration of hospital stayUp to 28 daysBetween groups

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026