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Respiratory Variations for Assessing Blood Withdrawal 2

NCT ID: NCT03066401

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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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 obese patients with dysmetabolic hyperferricemia.

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

PATIENTS: Obese patients with dysmetabolic hyperferricemia undergoing a therapeutic bleeding.

INTERVENTIONS: The investigators performed 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. The investigators 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

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Conditions

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Dysmetabolic Syndrome Hyperferritinemia Obese

Keywords

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hyperferritinemia dysmetabolic hyperferritinemia obese blood withdrawal respiratory variations inferior vena cava internal jugular vein ultrasound ultrasonography echography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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obese patients with dysmetabolic hyperferritinemia

PATIENTS: obese patients with dysmetabolic hyperferritinemia 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.

echography

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult patients of \> or equal 18 years
* dysmetabolic hyperferritinemia
* undergoing a therapeutic blood withdrawal
* health insured
* obese (body mass index \> or equal 30Kg/m²)

Exclusion Criteria

* pregnancy
* transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters
* clinical signs of active exhalation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien Preau, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHRU de Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01684-41

Identifier Type: OTHER

Identifier Source: secondary_id

2013_37

Identifier Type: -

Identifier Source: org_study_id