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

NCT ID: NCT01644760

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-09-17

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.

Conditions

Collapsibility of the Inferior Vena Cava

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study population

Healthy subjects with spontaneous ventilation, 18 to 50 years of age.

Group Type: EXPERIMENTAL

Ultrasounds with controlled breathing

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Muller, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 27003619 (View on PubMed)

Other Identifiers

2012-A00625-38

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/LM-01

Identifier Type: -

Identifier Source: org_study_id