Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation - Full Text View

Purpose

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.

Condition	Intervention
Collapsibility of the Inferior Vena Cava	Procedure: Ultrasounds with controlled breathing

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation: A Physiological Study on Healthy Volunteers

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

Collapsibility score for the IVC diameter [ Time Frame: Baseline (Day 0; cross-sectional study) ] [ Designated as safety issue: No ]
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) [ Time Frame: Baseline (Day 0; cross-sectional study) ] [ Designated as safety issue: No ]
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 excursion [ Time Frame: Baseline (Day 0; cross-sectional study) ] [ Designated as safety issue: No ]
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 Outcome Measures:

Collapsibility score for the IVC diameter >= 40% (presence/absence) [ Time Frame: Baseline (Day 0; cross sectional study) ] [ Designated as safety issue: No ]
percentage = ((max-min)/average)*100%
Collapsibility score for the IVC diameter >= 60% (presence/absence) [ Time Frame: Baseline (Day 0; cross sectional study) ] [ Designated as safety issue: No ]
percentage = ((max-min)/average)*100%
Mitral Doppler Wave E speed [ Time Frame: Baseline (Day 0; cross sectional study) ] [ Designated as safety issue: No ]
cm/s
Mitral Doppler Wave A speed [ Time Frame: Baseline (Day 0; cross sectional study) ] [ Designated as safety issue: No ]
cm/s
Tissue Doppler Wave E' speed [ Time Frame: Baseline (Day 0; cross sectional study) ] [ Designated as safety issue: No ]
cm/s
Simpson: FEVG [ Time Frame: Baseline (Day 0; cross sectional study) ] [ Designated as safety issue: No ]
%

Enrollment:	52
Study Start Date:	September 2012
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644760

Locations

France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator:

Laurent Muller, MD

Centre Hospitalier Universitaire de Nîmes

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01644760 History of Changes
Other Study ID Numbers:	LOCAL/2012/LM-01, 2012-A00625-38
Study First Received:	July 17, 2012
Last Updated:	March 26, 2013
Health Authority:	France: L’Agence nationale de sécurité du médicament et des produits de santé France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

Diaphragmatic excursion
normality

ClinicalTrials.gov processed this record on May 19, 2013