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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Mechanical Ventilation Bioelectrical Impedance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PEEP 5

Group Type ACTIVE_COMPARATOR

PEEP level

Intervention Type PROCEDURE

Patients will have variable PEEP levels and will be monitored

PEEP 0

Group Type ACTIVE_COMPARATOR

PEEP level

Intervention Type PROCEDURE

Patients will have variable PEEP levels and will be monitored

PEEP 10

Group Type EXPERIMENTAL

PEEP level

Intervention Type PROCEDURE

Patients will have variable PEEP levels and will be monitored

Interventions

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PEEP level

Patients will have variable PEEP levels and will be monitored

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes