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

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

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.

Study Overview

• Status: Completed
• Conditions: Collapsibility of the Inferior Vena Cava
• Intervention / Treatment: Procedure: Ultrasounds with controlled breathing

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Laurent Muller, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• Gignon L, Roger C, Bastide S, Alonso S, Zieleskiewicz L, Quintard H, Zoric L, Bobbia X, Raux M, Leone M, Lefrant JY, Muller L. Influence of Diaphragmatic Motion on Inferior Vena Cava Diameter Respiratory Variations in Healthy Volunteers. Anesthesiology. 2016 Jun;124(6):1338-46. doi: 10.1097/ALN.0000000000001096.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 17, 2012
• Study Completion (Actual): September 17, 2012

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimated): July 19, 2012

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Diaphragmatic excursion; normality
• Additional Relevant MeSH Terms: Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID Numbers: LOCAL/2012/LM-01; 2012-A00625-38 (Other Identifier: ANSM)