Lung CollapseN-LAT-EITNCT04235231
The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography
A study testing Bed tilting and Body positioning in people with Lung Collapse, run by Regional Hospital Liberec at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Collapse
- What is being tested?
- Bed tilting and Body positioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2021to 9 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary brain disease
- Hospitalization in Neurocenter, Neurointensive Care Unit
- Age>18 years
- Unconsciousness
- Artificial pulmonary ventilation
Who cannot join
- Intracranial hypertension
- History of primary lung disease
- The terminal stage of the disease
- Refractory hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Lung Collapse
- Being tested
- Bed tilting, Body positioning
- Keywords
- Lung Inhomogeneity, Lung Collapse, Atelectasis, Mechanical Ventilation, EIT, Bed tilting, Positioning, Neurocritical Care, Unconsciousness, Acute Brain Disease, Preventive Strategy
- Medical subject headings
- Pulmonary Atelectasis, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed tiltingDevice
15° lateral tilt, original product brand name LINET Eleganza 5
Body positioningOther
Also called Manual positioning of body by nurse
Manual positioning of body by nurse: left side, back, right side, using positioning pillows
| Study group | Role | What they receive |
|---|---|---|
| Lateral tilt bed | Experimental | Bed tilting (15° lateral tilt, original product brand name LINET Eleganza 5) Receives: Device: Bed tilting |
| Body positioning | Experimental | Manual positioning of body by nurse. Receives: Other: Body positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atelectasis/collapse
Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period
Measured: up to 24 weeks
Secondary outcomes (5)
Evaluating oxygenation parameters
Oxygen saturation
Measured: up to 24 weeks
Evaluating hemodynamic parameters
Hemodynamic monitoring: stroke volume variation (SVV)
Measured: up to 24 weeks
Cost effectiveness measurement between two groups
Therapeutic Intervention Scoring System (TISS)
Measured: up to 24 weeks
Profiling pneumonia incidence
Pneumonia score
Measured: up to 24 weeks
Comparing duration of stay in Neurocenter Neurointensive Care Unit
Days of hospitalization
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Jun 2021
- Primary completion17 Sep 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CollapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Liberec
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, University of Sao Paulo, Technology Agency of the Czech Republic
- Responsible party
- Principal investigator, Vera Spatenkova, MD, Ph.D., Regional Hospital Liberec
- Investigators
- Vera Spatenkova, MD, Ph.D., Study chair, NeuroCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235231
- Sponsor's protocol ID
- RHL-NICU-2020-01
- Acronym
- N-LAT-EIT
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2020
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04235231
- Acronym / sponsor ID
- N-LAT-EIT / RHL-NICU-2020-01
- Conditions
- Lung Collapse
- Keywords
- Lung Inhomogeneity, Lung Collapse, Atelectasis, Mechanical Ventilation, EIT, Bed tilting, Positioning, Neurocritical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Regional Hospital LiberecUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic, University of Sao Paulo, Technology Agency of the Czech Republic
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral tilt bed | Experimental | Device: Bed tiltingBed tilting (15° lateral tilt, original product brand name LINET Eleganza 5) |
| Body positioning | Experimental | Other: Body positioningManual positioning of body by nurse. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary brain disease
- Hospitalization in Neurocenter, Neurointensive Care Unit
- Age>18 years
- Unconsciousness
- Artificial pulmonary ventilation
Key exclusion criteria (4 listed)
- Intracranial hypertension
- History of primary lung disease
- The terminal stage of the disease
- Refractory hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed tilting15° lateral tilt, original product brand name LINET Eleganza 5 | Device | Lateral tilt bed |
| Body positioningAlso: Manual positioning of body by nurseManual positioning of body by nurse: left side, back, right side, using positioning pillows | Other | Body positioning |
Primary outcome
Atelectasis/collapse
Time frame: up to 24 weeks
Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period
5 secondary outcomes
Evaluating oxygenation parameters
Time frame: up to 24 weeks
Evaluating hemodynamic parameters
Time frame: up to 24 weeks
Cost effectiveness measurement between two groups
Time frame: up to 24 weeks
Profiling pneumonia incidence
Time frame: up to 24 weeks
Comparing duration of stay in Neurocenter Neurointensive Care Unit
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Spatenkova, MD, Ph.D. study chair
NeuroCenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed tilting and Body positioning in people with Lung Collapse, run by Regional Hospital Liberec at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atelectasis/collapse (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.