Clinical trial NCT01644760: Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation
Official title: Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation: A Physiological Study on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Collapsibility of the Inferior Vena Cava
Keywords: Diaphragmatic excursion
normality
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Collapsibility score for the IVC diameter
timeFrame: Baseline (Day 0; cross-sectional study)
measure: Collapsibility score for the IVC diameter >= 50% (presence/absence)
timeFrame: Baseline (Day 0; cross-sectional study)
measure: Diaphragmatic excursion
timeFrame: Baseline (Day 0; cross-sectional study)
Secondary outcomes:
measure: Collapsibility score for the IVC diameter >= 40% (presence/absence)
timeFrame: Baseline (Day 0; cross sectional study)
measure: Collapsibility score for the IVC diameter >= 60% (presence/absence)
timeFrame: Baseline (Day 0; cross sectional study)
measure: Mitral Doppler Wave E speed
timeFrame: Baseline (Day 0; cross sectional study)
measure: Mitral Doppler Wave A speed
timeFrame: Baseline (Day 0; cross sectional study)
measure: Tissue Doppler Wave E' speed
timeFrame: Baseline (Day 0; cross sectional study)
measure: Simpson: FEVG
timeFrame: Baseline (Day 0; cross sectional study)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Laurent Muller, MD
role: PRINCIPAL_INVESTIGATOR
References: