Respiratory Variations for Assessing Blood Withdrawal 2 (ReVAs2)

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

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.

Study Overview

• Status: Terminated
• Conditions: Obese; Hyperferritinemia; Dysmetabolic Syndrome
• Intervention / Treatment: Procedure: echography

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHRU de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Obese patients with dysmetabolic hyperferritinemia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (ΔIJVST)	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.	during a standardized respiratory maneuver, an average 1 hour maximum

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: ultrasound; ultrasonography; internal jugular vein; obese; echography; blood withdrawal; hyperferritinemia; inferior vena cava; respiratory variations; dysmetabolic hyperferritinemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Hyperferritinemia
• Other Study ID Numbers: 2013_37; 2013-A01684-41 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO