Obese Clinical Trial
— ReVAs2Official title:
Respiratory Variations in Diameters of the Inferior Vena Cava and the Internal Jugular Vein to Assess Blood Withdrawal in Patients With Dysmetabolic Hyperferritinemia
Verified date | February 2017 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Roger Salengro, CHRU de Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (?IVCST) | The primary endpoint was the ?IVCST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IVC diameters during a standardized ventilation. ?IVCST was calculated as follows: [(maximal diameter - minimal diameter)/maximal diameter].100. | during a standardized respiratory maneuver, an average 1 hour maximum | |
Secondary | blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (?IJVST) | The primary endpoint was the ?IJVST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IJV diameters during a standardized ventilation. ?IJVST was calculated as follows: [(maximal diameter - minimal diameter)/maximal diameter].100. | during a standardized respiratory maneuver, an average 1 hour maximum |
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