ReVAs: Respiratory Variations For Assessing Blood Withdrawal

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT03066414

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC) and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST) increase after a therapeutic bleeding in spontaneously breathing and non-obese patients with genetic hemochromatosis.

DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.

PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding.

INTERVENTIONS: Ultrasound measures and collected clinical parameters before and after a therapeutic bleeding, during a standardized respiratory maneuver.

MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. It measured the minimal and maximal IVC and IJV diameters during a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as follows: [(maximal diameter - minimal diameter)/maximal diameter].100.

Condition or Disease	Intervention/Treatment	Phase
Genetic Hemochromatosis	Procedure: echography

Study Design

Study Type:

Observational

Actual Enrollment :

27 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Respiratory Variations in Diameters of the Inferior Vena Cava and the Internal Jugular Vein to Assess Blood Withdrawal in Patients With Genetic Hemochromatosis

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
non-obese patients with genetic hemochromatosis PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding. INTERVENTIONS: The investigators performed ultrasound measurements (echography) and collected clinical parameters before and after a 300 to 500ml therapeutic bleeding, during a standardized respiratory maneuver.	Procedure: echography The inferior vena cava and the internal jugular vein diameters were measured by echography before and after blood withdrawal during a standardized respiratory maneuver

Arm

Intervention/Treatment

non-obese patients with genetic hemochromatosis

PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding. INTERVENTIONS: The investigators performed ultrasound measurements (echography) and collected clinical parameters before and after a 300 to 500ml therapeutic bleeding, during a standardized respiratory maneuver.

Procedure: echography

The inferior vena cava and the internal jugular vein diameters were measured by echography before and after blood withdrawal during a standardized respiratory maneuver

Outcome Measures

Primary Outcome Measures

blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST) [during a standardized respiratory maneuver, an average 1 hour maximum]
The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IVC diameters during a standardized ventilation. ΔIVCST was calculated as follows: [(maximal diameter - minimal diameter)/maximal diameter].100.

Secondary Outcome Measures

blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (ΔIJVST) [during a standardized respiratory maneuver, an average 1 hour maximum]
The primary endpoint was the ΔIJVST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IJV diameters during a standardized ventilation. ΔIJVST was calculated as follows: [(maximal diameter - minimal diameter)/maximal diameter].100.