Clinical Trial: Respiratory Variations For Assessing Blood Withdrawal

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.


Detailed Summary:
Sponsor: University Hospital, Lille

Current Primary Outcome: blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (ΔIJVST) [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: November 9, 2016
Date Started: February 2015
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2017