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

Not Applicable

Completed

• Conditions: Lung Collapse
• Interventions: Device: Bed tilting; Other: Body positioning

• Registration Number: NCT04235231
• Lead Sponsor: Regional Hospital Liberec

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.

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 Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Study Start: 2021-06-01
• Primary Completion: 2024-09-17
• Study Completion: 2024-10-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral tilt bed	Bed tilting	Bed tilting (15° lateral tilt, original product brand name LINET Eleganza 5)
Body positioning	Body positioning	Manual positioning of body by nurse.

Primary Outcome Measures

Name	Time	Method
Atelectasis/collapse	up to 24 weeks	Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Regional Hospital Liberec; 🇨🇿 Liberec, Czechia