Skip to main content
OpenTrials
Completed

NCT Number: NCT03704038

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dubrava

Zagreb, City of Zagreb, 1000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP level

Procedure

Patients will have variable PEEP levels and will be monitored

Primary outcomes

  1. Change of nondependent / dependent tidal variation

    Time frame: Baseline, 10 and 90 minutes post lateral positioning

    Measured by EIT

Secondary outcomes

  1. Change of a-A gradient

    Time frame: Baseline, 10 and 90 minutes post lateral positioning

    Measured by ABG analysis

  2. Duration of hospital stay

    Time frame: Up to 28 days

    Between groups

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2018
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.