The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography (N-LAT-EIT)

April 2, 2025 updated by: Vera Spatenkova, MD, Ph.D., Regional Hospital Liberec

The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography: A Pilot Prospective Randomized Study in Neurocritical Care

Prevention of lung inhomogeneity is an essential part of preventive strategy in neurocritical care, reducing the risks of secondary brain damage from hypoxemia, hypo/hypercapnia or pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the monocentric, intervention, prospective, randomized study, the investigators will examine the effect of lateral tilting (routinely used in critical care) on the lung inhomogeneity that will be analyzed by electrical impedance tomography (EIT) in the unconscious patients with acute primary brain disease and artificial pulmonary ventilation. Two types of lateral tilting will be compared: manual positioning of body by nurse versus the bed tilting (15° lateral tilt, original company (LINET) and product brand name (Eleganza 5).

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Liberec, Czechia, 46010
        • Regional Hospital Liberec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary brain disease
  • Hospitalization in Neurocenter, Neurointensive Care Unit
  • Age>18 years
  • Unconsciousness
  • Artificial pulmonary ventilation

Exclusion Criteria:

  • Intracranial hypertension
  • History of primary lung disease
  • The terminal stage of the disease
  • Refractory hemodynamic instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lateral tilt bed
Bed tilting (15° lateral tilt, original product brand name LINET Eleganza 5)
Device: Bed tilting
15° lateral tilt, original product brand name LINET Eleganza 5
Experimental: Body positioning
Manual positioning of body by nurse.
Other: Body positioning
Manual positioning of body by nurse: left side, back, right side, using positioning pillows
Other Names:
  • Manual positioning of body by nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atelectasis/collapse
Time Frame: up to 24 weeks
Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating oxygenation parameters
Time Frame: up to 24 weeks
Oxygen saturation
up to 24 weeks
Evaluating hemodynamic parameters
Time Frame: up to 24 weeks
Hemodynamic monitoring: stroke volume variation (SVV)
up to 24 weeks
Cost effectiveness measurement between two groups
Time Frame: up to 24 weeks
Therapeutic Intervention Scoring System (TISS)
up to 24 weeks
Profiling pneumonia incidence
Time Frame: up to 24 weeks
Pneumonia score
up to 24 weeks
Comparing duration of stay in Neurocenter Neurointensive Care Unit
Time Frame: up to 24 weeks
Days of hospitalization
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Liberec

Collaborators

Charles University, Czech Republic
University of Sao Paulo
Technology Agency of the Czech Republic

Investigators

  • Study Chair: Vera Spatenkova, MD, Ph.D., NeuroCenter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

September 17, 2024

Study Completion (Actual)

October 9, 2024

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHL-NICU-2020-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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