Effect of Passive Leg Raising for Fluid Responsiveness

Not Applicable

• Conditions: Body Fluid Retention; Impedance; Cardiac Output, Low
• Interventions: Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis; Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System

• Registration Number: NCT02702544
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) while lifting the leg at different angles. The measurement lasted 12 minutes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-08
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• give voluntary consent to participate in the study
• no clinical cardiovascular disease during the 6 months proceeding entry

Exclusion Criteria

• not meet above criteria
• episode of illness (for example: infection)
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
legs raised for 60 degrees	CardioScreen 1000 - Haemodynamic Measurement System, Medis	patient is placed on a flat surface, legs raised for 60 degrees, supported around ankles
legs raised for 20 degrees	CardioScreen 1000 - Haemodynamic Measurement System, Medis	patient is placed on a flat surface, legs raised for 20 degrees, supported around ankles
legs raised for 30 degrees	CardioScreen 1000 - Haemodynamic Measurement System, Medis	patient is placed on a flat surface, legs raised for 30 degrees, supported around ankles
legs raised for 60 degrees	SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System	patient is placed on a flat surface, legs raised for 60 degrees, supported around ankles
legs raised for 45 degrees	CardioScreen 1000 - Haemodynamic Measurement System, Medis	patient is placed on a flat surface, legs raised for 45 degrees, supported around ankles
legs raised for 45 degrees	SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System	patient is placed on a flat surface, legs raised for 45 degrees, supported around ankles
neutral position	CardioScreen 1000 - Haemodynamic Measurement System, Medis	the patient is in the neutral position, located on his back on a flat surface
legs raised for 30 degrees	SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System	patient is placed on a flat surface, legs raised for 30 degrees, supported around ankles
neutral position	SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System	the patient is in the neutral position, located on his back on a flat surface
legs raised for 20 degrees	SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System	patient is placed on a flat surface, legs raised for 20 degrees, supported around ankles

Primary Outcome Measures

Name	Time	Method
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation	1 day

Secondary Outcome Measures

Name	Time	Method
Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation	1 day
Changes in contractility parameter- acceleration index [1/100/s-2] during leg elevation	1 day
Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on leg elevation	1 day
Changes in blood pressure values [mmHg] induced by fluid removal on leg elevation	1 day
Changes in volumetric hemodynamic parameter- systemic vascular resistance index [dyn·s·cm-5·m-2] induced by fluid removal on leg elevation	1 day
Changes in vascular parameter- thoracic arterial complicance [ml/mmHg/m-2] during leg elevation	1 day

Trial Locations

Locations (1)

Medical University of Warsaw, Department of Emergency Medicine; 🇵🇱 Warsaw, Masovia, Poland