Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001501437
Ethics application status
Approved
Date submitted
1/10/2016
Date registered
28/10/2016
Date last updated
10/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound assessment of the diaphragm in healthy volunteers
Scientific title
Evaluation of normal values for assessment of the diaphragm through ultrasonography in a healthy population
Secondary ID [1] 290249 0
None
Universal Trial Number (UTN)
U1111-1188-1886
Trial acronym
Healthy Diaphragm US
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diaphragm ultrasound assessment 300459 0
Respiratory Muscles 300460 0
Condition category
Condition code
Respiratory 300318 300318 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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).
Intervention code [1] 296037 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299786 0
To report the normal values of the diaphragm thickening fraction in correlation with height
Timepoint [1] 299786 0
Echographic diaphragm assessment will be done only once at the subject enrollment
Primary outcome [2] 299926 0
To report the normal values of the diaphragm displacement in correlation with height
Timepoint [2] 299926 0
Echographic diaphragm assessment will be done only once at the subject enrollment
Primary outcome [3] 299927 0
To report the normal values of the diaphragm thickening fraction in correlation with weight
Timepoint [3] 299927 0
Echographic diaphragm assessment will be done only once at the subject enrollment
Secondary outcome [1] 328110 0
To report the normal values of the diaphragm displacement in correlation with age
Timepoint [1] 328110 0
Echographic diaphragm assessment will be done only once at the subject enrollment
Secondary outcome [2] 328746 0
To report the normal values of the diaphragm thickening fraction in correlation with age
Timepoint [2] 328746 0
Echographic diaphragm assessment will be done only once at the subject enrollment
Secondary outcome [3] 328747 0
To report the normal values of the diaphragm displacement in correlation with weight
Timepoint [3] 328747 0
Echographic diaphragm assessment will be done only once at the subject enrollment

Eligibility
Key inclusion criteria
We consider elegible all healthy subjects with an age equal or greater than 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be excluede if meeting one or more of the following criteria: 1) neuromuscular disease, 2) chronic respiratory disease or 3) chronic corticosteroid therapy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
We will enrol at least 300 healthy volunteers. The normal distribution will be assessed through the Kolmogorov Smirnov test. Parametric variables will be expressed as mean (standard deviation), while non parametric ones as median [25-75 interquartile range].
Differences between gender (male versus female) will be assessed through Student t-test or a Mann-Withney U test, as indicated.
The associations between ultrasonographic measurements and antropometric data will be assessed through a linear regression analisys to produce a correlation coefficient. Differences will be considered as statistically significant for p values lower than 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2016
Actual
2/11/2016
Date of last participant enrolment
Anticipated
30/10/2017
Actual
Date of last data collection
Anticipated
30/10/2017
Actual
Sample size
Target
300
Accrual to date
186
Final
Recruitment outside Australia
Country [1] 8281 0
Italy
State/province [1] 8281 0
Vercelli

Funding & Sponsors
Funding source category [1] 294618 0
Self funded/Unfunded
Name [1] 294618 0
Federico Longhini
Country [1] 294618 0
Italy
Primary sponsor type
Individual
Name
Federico Longhini
Address
c/o Anesthesia and Intensive Care Unit, Sant'Andrea Hospital, ASL VC, Corso Mario Abbiate, 13100, Vercelli, Italy
Country
Italy
Secondary sponsor category [1] 293480 0
None
Name [1] 293480 0
None
Address [1] 293480 0
None
Country [1] 293480 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296059 0
Comitato Etico Interaziendale A.S.O. SS.Antonio e Biagio e C.Arrigo di Alessandria
Ethics committee address [1] 296059 0
Azienda Ospedaliera di Alessandria
S.S. Antonio e Biagio e Cesare Arrigo
Via Venezia, 16
Alessandria – 15121
Ethics committee country [1] 296059 0
Italy
Date submitted for ethics approval [1] 296059 0
27/07/2016
Approval date [1] 296059 0
08/09/2016
Ethics approval number [1] 296059 0
AslVC.Rian.16.02

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69394 0
Dr Federico Longhini
Address 69394 0
c/o Anesthesia and Intensive Care Unit, Sant'Andrea Hospital, ASL VC, Corso Mario Abbiate, 13100, Vercelli, Italy
Country 69394 0
Italy
Phone 69394 0
+393475395967
Fax 69394 0
Email 69394 0
[email protected]
Contact person for public queries
Name 69395 0
Dr Federico Longhini
Address 69395 0
c/o Anesthesia and Intensive Care Unit, Sant'Andrea Hospital, ASL VC, Corso Mario Abbiate, 13100, Vercelli, Italy
Country 69395 0
Italy
Phone 69395 0
+393475395967
Fax 69395 0
Email 69395 0
[email protected]
Contact person for scientific queries
Name 69396 0
Dr Federico Longhini
Address 69396 0
c/o Anesthesia and Intensive Care Unit, Sant'Andrea Hospital, ASL VC, Corso Mario Abbiate, 13100, Vercelli, Italy
Country 69396 0
Italy
Phone 69396 0
+393475395967
Fax 69396 0
Email 69396 0
[email protected]

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