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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05372250
Other study ID # 2022-A00063-40
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2022
Est. completion date November 30, 2024

Study information

Verified date August 2022
Source Central Hospital, Nancy, France
Contact Marine Mervelet
Phone 0383153670
Email m.mervelet@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The EXDECHO study is the first randomized study evaluating the effect of four body positions on diaphragmatic excursion in obese patients by ultrasound. The investigators suppose that the course of the right diaphragmatic hemicupola would be increased by an increasingly horizontal position (gradual increase in the diaphragmatic excursion from standing to lying down). If this hypothesis is confirmed, kinesitherapists will have more informed positioning choices to improve the effectiveness of respiratory rehabilitation.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date November 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - to have a BMI greater than or equal to 30; - to have not had intense physical activity during the hour preceding the measurements; - to be enrolled in a social security plan; - to give a written consent; - to have underwent a pre-inclusion medicalexamination. Exclusion Criteria: - to have a respiratory pathology unrelated to obesity (sleep apnea syndrome, obesity-hypoventilation syndrome, restrictive ventilatory syndrome with no other known cause); - to have a cardiac pathology not stabilized by drug treatment and/or resulting in heart failure and/or requiring the fitting of a pacemaker or defibrillator; - to have a chronic inflammatory disease (rheumatoid arthritis, Crohn's disease, cirrhosis, etc.); - to have a chest deformity (kyphoscoliosis, funnel chest, etc.); - to be anactive smoking or former smoker (stopped for less than 3 months and total consumption > 10 pack-years); - to have an history of major surgery, surgery under general anesthesia for less than 3 months, or minimally invasive surgery for less than 1 year of the thoraco-abdomino-pelvic compartments; - to have a known sensitivity to monopropylene glycol (substance present in the sterile ultrasound gel); - temperature of the room in which the ultrasound measurements are carried out below 20°C or above 25°C; - subject under a measure of legal protection.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Measurement of the diaphragmatic excursion according to the position of the body by ultrasound
Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

Locations

Country Name City State
France Centre Hospitalier Régional Universitaire de Nancy Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound Day 0
Secondary Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and weight in kilograms. Day 0
Secondary Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and waist circumference in centimeters. Day 0
Secondary Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and BMI in kg/m². Weight in kilograms and height in meters will be combined to report BMI in kg/m². Day 0
Secondary Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and sex of the participant (male/female). Day 0
Secondary Comfort of the ultrasound examination felt by the patient via a questionnaire Positions, duration of the examination, pressure exerted by the probe: score from 0 (unpleasant) to 4 (acceptable) Day 0
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