Respiratory Variations For Assessing Blood Withdrawal

Completed

• Conditions: Genetic Hemochromatosis
• Interventions: Procedure: echography

• Registration Number: NCT03066414
• Lead Sponsor: University Hospital, Lille

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 Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-11-09
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Study First Posted: 2017-02-28
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• adult patients of > or equal 18 years
• genetic hemochromatosis
• undergoing a therapeutic blood withdrawal
• health insured
• non-obese (body mass index <30Kg/m²)

Exclusion Criteria

• pregnancy
• transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters
• clinical signs of active exhalation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-obese patients with genetic hemochromatosis	echography	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHRU de Lille; 🇫🇷 Lille, France