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

Not Applicable

Completed

• Conditions: Collapsibility of the Inferior Vena Cava
• Interventions: Procedure: Ultrasounds with controlled breathing

• Registration Number: NCT01644760
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-19
• Study Start: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study population	Ultrasounds with controlled breathing	Healthy subjects with spontaneous ventilation, 18 to 50 years of age.

Primary Outcome Measures

Name	Time	Method
Collapsibility score for the IVC diameter	Baseline (Day 0; cross-sectional study)	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.
Collapsibility score for the IVC diameter >= 50% (presence/absence)	Baseline (Day 0; cross-sectional study)	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.
Diaphragmatic excursion	Baseline (Day 0; cross-sectional study)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France