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

NCT03704038 | Completed

• 1 other identifier: 2018EIT
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Bioelectrical Impedance

Keywords

PEEP; Electrical impedance tomography; Mechanical ventialtion

Outcome Measures

Primary Outcomes (1)

• Change of nondependent / dependent tidal variation

  Measured by EIT

  Baseline, 10 and 90 minutes post lateral positioning

Secondary Outcomes (2)

• Change of a-A gradient

  Baseline, 10 and 90 minutes post lateral positioning

• Duration of hospital stay

  Up to 28 days

Study Arms (3)

PEEP 5

ACTIVE COMPARATOR

Procedure: PEEP level

PEEP 0

ACTIVE COMPARATOR

Procedure: PEEP level

PEEP 10

EXPERIMENTAL

Procedure: PEEP level

Interventions

PEEP level PROCEDURE

Patients will have variable PEEP levels and will be monitored

PEEP 0; PEEP 10; PEEP 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position
• signed informed consent form

You may not qualify if:

• preexisting moderate to severe obstructive (GOLD score \> 1) or restrictive lung disease (FVC \< 85%)
• history of organ transplant
• disseminated malignant disease
• pregnancy

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, City of Zagreb, 1000, Croatia

Location

Study Officials

• Andrej Šribar, MD, PhD

  Anesthesiologist and Critical Care specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in anesthesiology and intensive are medicine, Principal Investigator

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 12, 2018
• Study Start: June 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)