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The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography (N-LAT-EIT)

Primary Purpose

Lung Collapse

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Bed tilting
Body positioning
Sponsored by
Regional Hospital Liberec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Collapse focused on measuring Lung Inhomogeneity, Lung Collapse, Atelectasis, Mechanical Ventilation, EIT, Bed tilting, Positioning, Neurocritical Care, Unconsciousness, Acute Brain Disease, Preventive Strategy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Hospital LiberecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lateral tilt bed

Body positioning

Arm Description

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

Manual positioning of body by nurse.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2020
Last Updated
January 2, 2023
Sponsor
Regional Hospital Liberec
Collaborators
Charles University, Czech Republic, University of Sao Paulo, Technology Agency of the Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT04235231
Brief Title
The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Liberec
Collaborators
Charles University, Czech Republic, University of Sao Paulo, Technology Agency of the Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Collapse
Keywords
Lung Inhomogeneity, Lung Collapse, Atelectasis, Mechanical Ventilation, EIT, Bed tilting, Positioning, Neurocritical Care, Unconsciousness, Acute Brain Disease, Preventive Strategy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Research Randomizer
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lateral tilt bed
Arm Type
Experimental
Arm Description
Bed tilting (15° lateral tilt, original product brand name LINET Eleganza 5)
Arm Title
Body positioning
Arm Type
Experimental
Arm Description
Manual positioning of body by nurse.
Intervention Type
Device
Intervention Name(s)
Bed tilting
Intervention Description
15° lateral tilt, original product brand name LINET Eleganza 5
Intervention Type
Other
Intervention Name(s)
Body positioning
Other Intervention Name(s)
Manual positioning of body by nurse
Intervention Description
Manual positioning of body by nurse: left side, back, right side, using positioning pillows
Primary Outcome Measure Information:
Title
Atelectasis/collapse
Description
Assessed by electrical impedance tomography (EIT) or chest x-ray (CXR) at end of observation period
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Evaluating oxygenation parameters
Description
Oxygen saturation
Time Frame
up to 24 weeks
Title
Evaluating hemodynamic parameters
Description
Hemodynamic monitoring: stroke volume variation (SVV)
Time Frame
up to 24 weeks
Title
Cost effectiveness measurement between two groups
Description
Therapeutic Intervention Scoring System (TISS)
Time Frame
up to 24 weeks
Title
Profiling pneumonia incidence
Description
Pneumonia score
Time Frame
up to 24 weeks
Title
Comparing duration of stay in Neurocenter Neurointensive Care Unit
Description
Days of hospitalization
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vera Spatenkova, MD, Ph.D.
Phone
00420 724 027 126
Email
vera.spatenkova@nemlib.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Vendula Machackova, MSc., Ph.D.
Phone
00420 724 600 739
Email
vendula.machackova@nemlib.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Spatenkova, MD, Ph.D.
Organizational Affiliation
NeuroCenter
Official's Role
Study Chair
Facility Information:
Facility Name
Regional Hospital Liberec
City
Liberec
ZIP/Postal Code
46010
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Spatenkova, MD, Ph.D.
Phone
00420 724 027 126
Email
vera.spatenkova@nemlib.cz
First Name & Middle Initial & Last Name & Degree
Vendula Machackova, MSc., Ph.D.
Phone
00420 724 600 739
Email
vendula.machackova@nemlib.cz

12. IPD Sharing Statement

Plan to Share IPD
No

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

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