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

Lung Collapse Clinical Trial

— N-LAT-EIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235231
• Other study ID #: RHL-NICU-2020-01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Regional Hospital Liberec
• Contact: Vera Spatenkova, MD, Ph.D.
• Phone: 00420 724 027 126
• Email: vera.spatenkova[@]nemlib.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Collapse
• Pulmonary Atelectasis
• Shock

Intervention

Device:
• Bed tilting
15° lateral tilt, original product brand name LINET Eleganza 5

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

Locations

Country	Name	City	State
Czechia	Regional Hospital Liberec	Liberec

Sponsors (4)

Lead Sponsor	Collaborator
Regional Hospital Liberec	Charles University, Czech Republic, Technology Agency of the Czech Republic, University of Sao Paulo

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atelectasis/collapse	Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period	up to 24 weeks
Secondary	Evaluating oxygenation parameters	Oxygen saturation	up to 24 weeks
Secondary	Evaluating hemodynamic parameters	Hemodynamic monitoring: stroke volume variation (SVV)	up to 24 weeks
Secondary	Cost effectiveness measurement between two groups	Therapeutic Intervention Scoring System (TISS)	up to 24 weeks
Secondary	Profiling pneumonia incidence	Pneumonia score	up to 24 weeks
Secondary	Comparing duration of stay in Neurocenter Neurointensive Care Unit	Days of hospitalization	up to 24 weeks