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

Not Applicable

Completed

• Conditions: Collapsibility of the Inferior Vena Cava

• 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

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%
Tissue Doppler Wave E' speed	Baseline (Day 0; cross sectional study)	cm/s
Simpson: FEVG	Baseline (Day 0; cross sectional study)
Mitral Doppler Wave E speed	Baseline (Day 0; cross sectional study)	cm/s

Trial Locations

Locations (1)

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