- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351201
Effect of Head and Neck Positioning on Lung Sliding in Healthy Volunteers
The Effect of Head and Neck Positioning on Lung Sliding: A Bedside Comparison at 0°, 20°, and 40° in Healthy Volunteer
The goal of this clinical study is to learn how different head-of-bed positions affect lung movement during breathing in healthy adults. Researchers want to understand whether raising the head of the bed changes how the lungs move, which may help guide patient positioning in emergency and intensive care settings.
The main questions this study aims to answer are:
Does lung movement change when the head of the bed is positioned at zero, twenty, or forty degrees?
Are there differences in lung movement between the right and left lungs?
Are there differences between the upper (apical) and lower (basal) parts of the lungs?
Participants will be healthy adult volunteers between eighteen and sixty years of age. Each participant will lie on a bed in three different positions: flat, with the head raised to twenty degrees, and with the head raised to forty degrees.
During each position, researchers will use bedside lung ultrasound, a painless and non-invasive imaging method, to measure lung movement at four areas of the chest. No medications, injections, or invasive procedures will be used.
This study may help health care providers better understand how body position affects breathing and support safer and more effective positioning of patients with breathing problems.
Study Overview
Detailed Description
This is a prospective, low-risk, non-drug interventional clinical study designed to evaluate the effect of head-of-bed elevation on lung sliding movement in healthy adult volunteers. Lung sliding is a dynamic ultrasound finding that reflects the movement between the visceral and parietal pleura during respiration and provides information about lung aeration and respiratory mechanics.
The primary objective of the study is to quantitatively assess changes in lung sliding amplitude across three standardized head-of-bed positions: zero degrees (supine), twenty degrees, and forty degrees. Measurements will be obtained using bedside lung ultrasonography at four predefined anatomical locations: right apical, right basal, left apical, and left basal lung regions.
Secondary objectives include evaluating potential differences in lung sliding between the right and left lungs, comparing apical and basal lung regions, and assessing whether positional changes have region-specific effects on lung movement.
The study population will consist of thirty-one healthy adult volunteers aged eighteen to sixty years. Individuals with known respiratory disease, significant cardiopulmonary conditions, pregnancy, prior thoracic surgery, or inability to tolerate position changes will be excluded. All participants will provide written informed consent prior to enrollment.
Each participant will undergo lung ultrasound measurements in all three positions in a repeated-measures design. Lung sliding will be recorded using high-frequency linear ultrasound probes. Quantitative assessment will be performed using M-mode imaging, measuring pleural line displacement in millimeters. Mean values will be calculated for each position and anatomical region.
No investigational drugs, medical devices, or invasive procedures will be used. The only intervention is controlled head-of-bed positioning. The study is considered minimal risk. Potential discomfort related to short-term position changes, such as mild dizziness or transient shortness of breath, will be monitored, and measurements will be discontinued if symptoms occur.
Data will be analyzed using repeated measures statistical methods to compare lung sliding values across positions and regions. The findings are expected to improve understanding of the positional sensitivity of lung ultrasound measurements and may contribute to evidence-based recommendations for patient positioning in emergency and critical care settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye), 06170
- Ankara Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adult volunteers aged eighteen to sixty years.
- No history of acute or chronic respiratory disease.
- Body mass index between eighteen point five and twenty-nine point nine kilograms per square meter.
- Ability to understand the study procedures and provide written informed consent.
- No skin lesions or wounds at the chest wall that would interfere with lung ultrasound examination.
Exclusion Criteria:
- History of respiratory system diseases, including asthma, chronic obstructive pulmonary disease, bronchiectasis, pneumonia, or tuberculosis.
- Presence of chest wall deformities (such as kyphoscoliosis or pectus deformities) or history of thoracic surgery.
- Inability to tolerate position changes during the study, including development of dizziness, syncope, or shortness of breath.
- Pregnancy or breastfeeding.
- Known significant cardiac, neurological, or metabolic disease.
- Known allergy to ultrasound gel or latex.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Head-of-Bed Position Assessment (0°, 20°, 40°)
Participants in this single-arm study will undergo lung ultrasound assessments during a single study visit. Each participant will be positioned sequentially at three different head-of-bed angles: zero degrees (supine), twenty degrees, and forty degrees. At each position, lung sliding movement will be evaluated using bedside lung ultrasonography with a high-frequency linear probe. Measurements will be obtained from four predefined anatomical regions: right apical, right basal, left apical, and left basal lung areas. Lung sliding will be quantitatively assessed using M-mode imaging by measuring pleural line displacement. |
Controlled positioning of the participant with the head of the bed at zero, twenty, and forty degrees.
At each position, lung sliding movement will be assessed using bedside lung ultrasound with a high-frequency linear probe.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Lung Sliding Amplitude Across Different Head-of-Bed Positions
Time Frame: Periprocedural (during a single study visit)
|
Lung sliding amplitude will be quantitatively measured using bedside lung ultrasonography in healthy adult participants.
Measurements will be obtained at four predefined anatomical regions (right apical, right basal, left apical, and left basal lung areas) while participants are positioned sequentially at three head-of-bed angles: zero degrees, twenty degrees, and forty degrees.
Lung sliding amplitude will be assessed using M-mode imaging by measuring pleural line displacement in millimeters.
Mean values for each position will be calculated and compared to evaluate the effect of head-of-bed elevation on lung sliding movement.
|
Periprocedural (during a single study visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Lung Sliding Amplitude Between Right and Left Lungs
Time Frame: Periprocedural (during a single study visit)
|
Lung sliding amplitude values obtained from the right and left lungs will be compared to assess side-related differences in lung movement.
Measurements will be performed at both apical and basal regions of each lung using bedside lung ultrasonography while participants are positioned at three different head-of-bed angles (zero, twenty, and forty degrees).
This analysis will evaluate whether lung sliding differs between the right and left lungs under different positional conditions.
|
Periprocedural (during a single study visit)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: İLKER ŞİRİN, Ankara Etlik City Hospital
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AEŞH-EK-2025-305
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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