Effect of Passive Leg Raising for Fluid Responsiveness

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Passive Leg Rasing on Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal

Conditions
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Body Fluid Retention, Impedance, Cardiac Output, Low

Intervention / Treatment
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* Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis
* Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neutral position<br>the patient is in the neutral position, located on his back on a flat surface | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis<br>* Impedance cardiography (ICG)<br>Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System<br>* Blood pressure monitoring every 1 min during leg elevation<br>|
| Experimental: legs raised for 20 degrees<br>patient is placed on a flat surface, legs raised for 20 degrees, supported around ankles | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis<br>* Impedance cardiography (ICG)<br>Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System<br>* Blood pressure monitoring every 1 min during leg elevation<br>|
| Experimental: legs raised for 30 degrees<br>patient is placed on a flat surface, legs raised for 30 degrees, supported around ankles | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis<br>* Impedance cardiography (ICG)<br>Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System<br>* Blood pressure monitoring every 1 min during leg elevation<br>|
| Experimental: legs raised for 45 degrees<br>patient is placed on a flat surface, legs raised for 45 degrees, supported around ankles | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis<br>* Impedance cardiography (ICG)<br>Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System<br>* Blood pressure monitoring every 1 min during leg elevation<br>|
| Experimental: legs raised for 60 degrees<br>patient is placed on a flat surface, legs raised for 60 degrees, supported around ankles | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis<br>* Impedance cardiography (ICG)<br>Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System<br>* Blood pressure monitoring every 1 min during leg elevation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in volumetric hemodynamic parameter- stroke volume [ml] 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 fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation |  | 1 day | 
| Changes in blood pressure values [mmHg] 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 | 
| Changes in contractility parameter- acceleration index [1/100/s-2] during leg elevation |  | 1 day |