Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation

Study Overview
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Brief Summary
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The main objective of this study is to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility of the inferior vena cava.

Detailed Description
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Secondary objectives of this study are: to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 40% collapsibility of the inferior vena cava (IVC). to determine a threshold value of diaphragmatic excursion (ultrasound measures: expiration versus inspiration)that best predicts a 100% collapsibility of the IVC. to determine the location of the cutting plane for the TM analysis of collapsibility of the IVC. to evaluate the hemodynamic conditions of normal healthy volunteers. to detect any abnormality of cardiac function.

Official Title
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Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation: A Physiological Study on Healthy Volunteers

Conditions
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Collapsibility of the Inferior Vena Cava

Intervention / Treatment
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* Procedure: Ultrasounds with controlled breathing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The volunteer must have given his/her informed and signed consent The volunteer must be insured or beneficiary of a health insurance plan Exclusion Criteria: The volunteer is participating in another study The volunteer is in an exclusion period determined by a previous study The volunteer is under judicial protection, under tutorship or curatorship The volunteer refuses to sign the consent It is impossible to correctly inform the volunteer The patient is pregnant, parturient, or breastfeeding The volunteer has known heart disease like heart failure, cardiac arrhythmia The volunteer takes cardiotropics The volunteer has known lung disease: obstructive or restrictive respiratory failure The volunteer has clinical signs of COPD (coughing with morning sputum in a smoking subject) Any emergency situation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study population<br>Healthy subjects with spontaneous ventilation, 18 to 50 years of age. | Procedure: Ultrasounds with controlled breathing<br>* The patient will have cardiac, abdominal and thoracic ultrasounds with controlled and monitored inspiratory effort. This gesture takes about 40 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collapsibility score for the IVC diameter | percentage = ((max-min)/average)*100% Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion. | Baseline (Day 0; cross-sectional study) | 
| Collapsibility score for the IVC diameter >= 50% (presence/absence) | percentage = ((max-min)/average)*100% Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion. | Baseline (Day 0; cross-sectional study) | 
| Diaphragmatic excursion | Maximum distance between the position of the diaphragmatic dome during inspiration versus expiration (cm) Three variables are necessary to respond to the primary objective: (the collapsibility score for the IVC diameter; (2) whether or not this score is >= 50%; and (3) a measure of the diaphragmatic excursion. | Baseline (Day 0; cross-sectional study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collapsibility score for the IVC diameter >= 40% (presence/absence) | percentage = ((max-min)/average)*100% | Baseline (Day 0; cross sectional study) | 
| Collapsibility score for the IVC diameter >= 60% (presence/absence) | percentage = ((max-min)/average)*100% | Baseline (Day 0; cross sectional study) | 
| Mitral Doppler Wave E speed | cm/s | Baseline (Day 0; cross sectional study) | 
| Mitral Doppler Wave A speed | cm/s | Baseline (Day 0; cross sectional study) | 
| Tissue Doppler Wave E' speed | cm/s | Baseline (Day 0; cross sectional study) | 
| Simpson: FEVG |  | Baseline (Day 0; cross sectional study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragmatic excursion, normality