The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography

NCT ID: NCT04235231

Last Updated: 2025-04-06

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

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-10-09

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Lung Collapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Research Randomizer

Study Groups

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Lateral tilt bed

Bed tilting (15° lateral tilt, original product brand name LINET Eleganza 5)

Group Type EXPERIMENTAL

Bed tilting

Intervention Type DEVICE

15° lateral tilt, original product brand name LINET Eleganza 5

Body positioning

Manual positioning of body by nurse.

Group Type EXPERIMENTAL

Body positioning

Intervention Type OTHER

Manual positioning of body by nurse: left side, back, right side, using positioning pillows

Interventions

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Bed tilting

15° lateral tilt, original product brand name LINET Eleganza 5

Intervention Type DEVICE

Body positioning

Manual positioning of body by nurse: left side, back, right side, using positioning pillows

Intervention Type OTHER

Other Intervention Names

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Manual positioning of body by nurse

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role collaborator

Technology Agency of the Czech Republic

UNKNOWN

Sponsor Role collaborator

Regional Hospital Liberec

OTHER

Sponsor Role lead

Responsible Party

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Vera Spatenkova, MD, Ph.D.

Head of Neurocenter

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vera Spatenkova, MD, Ph.D.

Role: STUDY_CHAIR

NeuroCenter

Locations

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Regional Hospital Liberec

Liberec, , Czechia

Site Status

Countries

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Czechia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RHL-NICU-2020-01

Identifier Type: -

Identifier Source: org_study_id

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