Respiratory Variations For Assessing Blood Withdrawal

NCT03066414 | Completed

• 2 other identifiers: 2013_382013-A01689-36
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Genetic Hemochromatosis

Keywords

hemochromatosis; blood withdrawal; respiratory variations; inferior vena cava; internal jugular vein; ultrasound; ultrasonography; echography

Outcome Measures

Primary Outcomes (1)

• blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST)

  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.

  during a standardized respiratory maneuver, an average 1 hour maximum

Secondary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

echography PROCEDURE

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

non-obese patients with genetic hemochromatosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-obese patients with genetic hemochromatosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

MeSH Terms

Conditions

Hemochromatosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Sébastien Preau, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: February 28, 2017
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)