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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01644760
Enrollment
52
Registered
2012-07-19
Start date
2012-09-30
Completion date
2012-09-17
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Collapsibility of the Inferior Vena Cava

Keywords

Diaphragmatic excursion, normality

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.

Interventions

PROCEDUREUltrasounds with controlled breathing

The patient will have cardiac, abdominal and thoracic ultrasounds with controlled and monitored inspiratory effort. This gesture takes about 40 minutes.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Collapsibility score for the IVC diameterBaseline (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 excursionBaseline (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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026