RecruitingACTRN12616001501437

Ultrasound assessment of the diaphragm in healthy volunteers

Evaluation of normal values for assessment of the diaphragm through ultrasonography in a healthy population


Sponsor

Federico Longhini

Enrollment

300 participants

Start Date

Nov 2, 2016

Study Type

Observational

Conditions

Summary

Ultrasound has been widely introduced in the clinical practice in the intensive care unit (ICU) to evaluate the diaphragm function in patients undergoing mechanical ventilation. Despite the increasing number of data in critically ill patients, a few is know about the normal measurements values in healthy volunteers. With the present study we aim to assess normal values of diaphragm ultrasound in a large population of healthy volunteers and to correlate them with some anthropometric data. We will enrol at least 300 volunteers without neuromuscular disease, chronic respiratory disease or corticosteroid therapy. After excluding paradoxical movement or palsy of any of the two emi-diaphragm, we will evaluate the cranio-caudal displacement and the thickening fraction of the diaphragm. We will also collect anthropometric data (i.e. height, weight, gender, age). After all data collection, we will describe the echographic measurements according to the anthropometric characteristics.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is using ultrasound to measure the movement and thickness of the diaphragm — the main breathing muscle — in healthy people. While ultrasound is already used to check the diaphragm in ICU patients, doctors don't yet have good normal reference values from healthy people. By studying at least 300 healthy volunteers, researchers hope to build a reliable set of normal measurements to compare against when patients are unwell. You may be eligible if: - You are 18 years of age or older - You are in generally good health You may NOT be eligible if: - You have a neuromuscular disease - You have a chronic respiratory condition (e.g., COPD, asthma) - You are on long-term corticosteroid therapy Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

After meeting all inclusion and no exclusion criteria, healthy volunteers are asked to undergo to ultrasound assessment of the diaphragm. While normally breathing, at rest, the investigator checks if

After meeting all inclusion and no exclusion criteria, healthy volunteers are asked to undergo to ultrasound assessment of the diaphragm. While normally breathing, at rest, the investigator checks if none of both emi-diaphragm is affected by palsy or by some paradoxical motion. Therefore, two types of measurement are record: 1) the cranio-caudal displacement and 2) the thickening fraction. The cranio-caudal displacement is performed using a 3.5–5 MHz probe. The probe is placed immediately below the right or left costal margin in the midclavicular line, or in the right or left anterior axillary line and is directed medially, cephalad and dorsally, so that the ultrasound beam reaches perpendicularly the posterior third of the corresponding hemidiaphragm. The two-dimensional (2D) mode is initially used to obtain the best approach and select the exploration line; the M-mode is then used to display the motion of the anatomical structures along the selected line. Patients are scanned along the long axis of the intercostal spaces, with the liver serving as an acoustic window to the right, and the spleen to the left. Normal inspiratory diaphragmatic movement is caudal, since the diaphragm moves toward the probe; normal expiratory trace is cranial, as the diaphragm moves away from the probe. In the M mode, the diaphragmatic excursion (displacement, cm), the speed of diaphragmatic contraction (slope, cm/s), the inspiratory time (Tinsp, s) and the duration of the cycle (Ttot, s) can be measured (Matamis et al. Intensive Care Med (2013) 39:801–810). The thickening fraction is evaluated in the zone of apposition of the diaphragm to the rib cage. The zone of apposition is the area of the chest wall where the abdominal contents reach the lower rib cage. In this area, the diaphragm is observed as a structure made of three distinct layers: a non-echogenic central layer bordered by two echogenic layers, the peritoneum and the diaphragmatic pleurae. To obtain adequate images of diaphragmatic thickness in M mode and 2D mode, a linear high-frequency probe (C10 MHz) is necessary. The diaphragmatic thickness can be measured during quiet spontaneous breathing and during a maximal inspiratory and expiratory effort. An index of diaphragmatic thickening, the thickening fraction (TF) can be calculated using the M mode (TF = thickness at endinspiration - thickness at end-expiration/thickness at end-expiration) (Matamis et al. Intensive Care Med (2013) 39:801–810).


Locations(1)

Vercelli, Italy

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ACTRN12616001501437


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