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

NCT04235231 | Completed

• 1 other identifier: RHL-NICU-2020-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Collapse

Keywords

Lung Inhomogeneity; Lung Collapse; Atelectasis; Mechanical Ventilation; EIT; Bed tilting; Positioning; Neurocritical Care; Unconsciousness; Acute Brain Disease; Preventive Strategy

Outcome Measures

Primary Outcomes (1)

• Atelectasis/collapse

  Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period

  up to 24 weeks

Secondary Outcomes (5)

• Evaluating oxygenation parameters

  up to 24 weeks

• Evaluating hemodynamic parameters

  up to 24 weeks

• Cost effectiveness measurement between two groups

  up to 24 weeks

• Profiling pneumonia incidence

  up to 24 weeks

• Comparing duration of stay in Neurocenter Neurointensive Care Unit

  up to 24 weeks

Study Arms (2)

Lateral tilt bed

EXPERIMENTAL

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

Device: Bed tilting

Body positioning

EXPERIMENTAL

Manual positioning of body by nurse.

Other: Body positioning

Interventions

Bed tilting DEVICE

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

Lateral tilt bed

Body positioning OTHER

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

Also known as: Manual positioning of body by nurse

Body positioning

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Regional Hospital Liberec: lead
• Charles University, Czech Republic: collaborator
• University of Sao Paulo: collaborator
• Technology Agency of the Czech Republic: collaborator

Study Sites (1)

Regional Hospital Liberec

Liberec, 46010, Czechia

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Unconsciousness

Interventions

Posture

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vera Spatenkova, MD, Ph.D.

  NeuroCenter

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Research Randomizer
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurocenter

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 21, 2020
• Study Start: June 1, 2021
• Primary Completion: September 17, 2024
• Study Completion: October 9, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)