NCT01644760|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
52
1 country
1
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 17, 2012
Actual (reported)Study Completion
September 17, 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 17, 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 17, 2012
Actual (reported)July 19, 2012
Actual (reported)September 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 17, 2012
Actual (reported)September 17, 2012
Actual (reported)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)
Collapsibility score for the IVC diameter >= 40% (presence/absence)
Baseline (Day 0; cross sectional study)
Collapsibility score for the IVC diameter >= 60% (presence/absence)
Baseline (Day 0; cross sectional study)
Mitral Doppler Wave E speed
Baseline (Day 0; cross sectional study)
Mitral Doppler Wave A speed
Baseline (Day 0; cross sectional study)
Tissue Doppler Wave E' speed
Baseline (Day 0; cross sectional study)
Healthy subjects with spontaneous ventilation, 18 to 50 years of age.
The patient will have cardiac, abdominal and thoracic ultrasounds with controlled and monitored inspiratory effort. This gesture takes about 40 minutes.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
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.
Laurent Muller, MD
Centre Hospitalier Universitaire de Nīmes
52 participants (actual enrollment reported by the registry).
First Submitted
July 17, 2012
First Posted
July 19, 2012
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 17, 2012
Actual (reported)Study Completion
September 17, 2012
Actual (reported)Last Updated
November 19, 2025
Record last verified: 2015-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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