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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Bioelectrical Impedance
• Intervention / Treatment: Procedure: PEEP level

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 1000
      • University Hospital Dubrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEEP 5	Procedure: PEEP level; Patients will have variable PEEP levels and will be monitored
Active Comparator: PEEP 0	Procedure: PEEP level; Patients will have variable PEEP levels and will be monitored
Experimental: PEEP 10	Procedure: PEEP level; Patients will have variable PEEP levels and will be monitored

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of nondependent / dependent tidal variation	Measured by EIT	Baseline, 10 and 90 minutes post lateral positioning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of a-A gradient	Measured by ABG analysis	Baseline, 10 and 90 minutes post lateral positioning
Duration of hospital stay	Between groups	Up to 28 days

Collaborators and Investigators

• Sponsor: University Hospital Dubrava
• Investigators: Principal Investigator: Andrej Šribar, MD, PhD, Anesthesiologist and Critical Care specialist

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Electrical impedance tomography; PEEP; Mechanical ventialtion
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: 2018EIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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