The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography: A Pilot Prospective Randomized Study in Neurocritical Care
Phase: NA
Conditions: Lung Collapse
Sponsor: Regional Hospital Liberec

 
 
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Title: The effect of lateral tilt on ventilation distribution in lungs assessed by electrical 
impedance tomography: A pilot prospective randomized study in neurocritical care 
 
Short Title: N-LAT-EIT (Neurocritical care – LATeral – Electrical Impedance Tomography) 
 
 
 
 
Vera Spatenkova, M.D., Ph.D. 
 
 
January 2020 
 
RHL-NICU-2020-01 
 
 

 
 
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PROTOCOL 
 
The effect of lateral tilt on ventilation distribution in lung assessed by electrical 
impedance tomography: A pilot prospective randomized study in neurocritical care 
 
N-LAT-EIT (Neurocritical care – LATeral – Electrical Impedance Tomography) 
 
Study Objectives 
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. 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). Two types of lateral tilting will be compared: manual positioning of body 
by nurse versus the bed tilting (15° lateral tilt, original company name (LINET) and product 
brand name Eleganza 5). 
 
Type of study 
1. Monocentric: Neurointensive Care Unit (NICU), Regional Hospital Liberec (research  
organization);  
2. Prospective; 
3. Randomized; 
4. Intervention: parallel assignment; 
5. Blind for statistics: statistics will only know type A or B randomization; 
6. Patients: Pilot data in 50 patients, following a statistical evaluation, the study will 
continue with a total of 200 patients. 
 
Entry criteria 
1. Primary brain disease; 
2. Hospitalization in NICU, Neurocenter; 
3. Age >18 up to 99 years; 
4. Unconsciousness; 
5. Artificial pulmonary ventilation; 
6. Available EIT device. 
 
Exclusion criteria 
1. Intracranial hypertension; 
2. History of primary lung disease; 
3. The terminal stage of the disease; 
4. Refractory hemodynamic instability. 
 
The primary aim 
Atelectasis/collapse assessed by EIT or chest x-ray (CXR) at end of observation period. 
 
The secondary aims 
1. Evaluating oxygenation parameters; 
2. Evaluating hemodynamic parameters: stroke volume variation (SVV) and cardiac 
index (CI) in one type of hemodynamic monitor; 
3. Comparing staying in Neurocenter Neurointensive Care Unit and cost effectiveness 
between two groups; 
4. Profiling pneumonia incidence between two groups.  

 
 
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Study groups (random assignment) 
1. Manual positioning of body by nurse: left side, back, right side using positioning 
pillows; 
2. Bed tilting: 15° lateral tilt, LINET Eleganza 5. 
 
Study duration 
Start of study: January 2020 
End of study: pilot study after recruitment of 50 patients. Complete study after recruitment  
of 200 patients. 
 
 
 
 
Statistical Analysis Plan 
 
 
Running statistical analysis will be performed after recruitment of 50 patients. Ventilation 
distribution in lungs will be evaluated by EIT and in case of non-significant differences  
in detecting lung inhomogeneity and risk of pneumonia among group 1 and 2, the study will 
continue. 
Complete study analysis will be performed after recruitment of 200 patients. 
Continuous variables will be assessed using t-tests or Mann-Whitney tests depending on data 
distribution. Categorial variables will be assessed using chi-square tests. Multivariate logistic 
regression analysis will be used estimating the occurrence of pneumonia versus EIT related 
measures of lung inhomogeneity. For assessing the association between measured 
oxygenation, EIT derived parameters and ventilator parameters, the Pearson or Spearman 
correlation method will be used, depending on parameters’ distribution.  
 
 
Liberec, January 7th, 2020 
Vera Spatenkova, M.D., Ph.D.