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Completed

NCT Number: NCT01644760

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasounds with controlled breathing

Procedure

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

Primary outcomes

  1. Collapsibility score for the IVC diameter

    Time frame: 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.

  2. Collapsibility score for the IVC diameter >= 50% (presence/absence)

    Time frame: 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.

  3. Diaphragmatic excursion

    Time frame: 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 outcomes

  1. Collapsibility score for the IVC diameter >= 40% (presence/absence)

    Time frame: Baseline (Day 0; cross sectional study)

    percentage = ((max-min)/average)*100%

  2. Collapsibility score for the IVC diameter >= 60% (presence/absence)

    Time frame: Baseline (Day 0; cross sectional study)

    percentage = ((max-min)/average)*100%

  3. Mitral Doppler Wave E speed

    Time frame: Baseline (Day 0; cross sectional study)

    cm/s

  4. Mitral Doppler Wave A speed

    Time frame: Baseline (Day 0; cross sectional study)

    cm/s

  5. Tissue Doppler Wave E' speed

    Time frame: Baseline (Day 0; cross sectional study)

    cm/s

  6. Simpson: FEVG

    Time frame: Baseline (Day 0; cross sectional study)

    %

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.