Thoracic Fluid Content During Hypervolemic Hemodilution

Study Overview
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Brief Summary
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Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device (Osypka Medical). The ICON device is often called thoracic electrical bio-impedance that based on measuring the changes in total resistance of the thorax to electric current and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid. Although TFC is a measure of both extra and intra-vascular thoracic fluid, it provides an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary edema. Although many studies were done on the ability of TFC to detect pulmonary edema in preeclampsia, ARDS, heart failure, weaning from mechanical ventilation and during fluid management in prolonged surgery , yet, there is no study before was done on the use of TFC as a guide for fluid therapy during hypervolemic hemodilution in major obstetric surgery in patients with placenta accreta as one of the most common etiologies of life-threatening obstetric hemorrhage and the most common cause of peripartum hysterectomy Aim of the work: To use TFC as a guide for 6% HES infusion of hypervolemic hemodilution in patients with placenta accreta to avoid fluid overload. Objectives: To calculate LUS score at the end of infusion. To evaluate TFC in k ohm-1. To assess oxygen saturation, PO2 and P/F ratio in ABG. To calculate the total infused volume in milliliters.

Official Title
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The Use of Thoracic Fluid Content as a Guide for 6% HES Infusion During Hypervolemic Hemodilution in Patients With Placenta Accreta. A Randomized Controlled Trial.

Conditions
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Pulmonary Edema

Intervention / Treatment
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* Device: Thoracic fluid content estimation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female 18-45 years old ASA I-II Exclusion Criteria: younger than 18 years, ASA > or = III patients with respiratory, cardiac disease, cardiac arrhythmias, body mass index above 40 kg/m2 renal insufficiency, sepsis, hypovolemia denoted by PPV > 13 detected after start of mechanical ventilation, preoperative baseline LUS score 10 or more, TFC > or = 26 k ohm-1, patients with neck or chest lesions that impair the application of cardiometry electrodes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>will receive a hypervolemic hemodilution with an IV infusion load of 6% HES.The infusion will be started preoperatively and will stop after completion of the infused volume. LUS evaluation will be done before start and after the end of the infusion. | Device: Thoracic fluid content estimation<br>* The patient will be monitored for thoracic fluid content and LUS score. The infusion will stop if TFC reaches 40 k ohm-1 or after completion of the infused volume. LUS evaluation will be done before the start and after the end of the infusion.<br>* Other names: extravascular lung water estimation;|
| Experimental: The TFC Group<br>will receive hypervolemic hemodilution with an IV infusion load of 6% HES.The infusion will be started preoperatively . The patient will be monitored for thoracic fluid content and LUS score. The infusion will stop if TFC reaches 40 k ohm-1 or after completion of the infused volume. LUS evaluation will be done before start and after the end of the infusion. | Device: Thoracic fluid content estimation<br>* The patient will be monitored for thoracic fluid content and LUS score. The infusion will stop if TFC reaches 40 k ohm-1 or after completion of the infused volume. LUS evaluation will be done before the start and after the end of the infusion.<br>* Other names: extravascular lung water estimation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of pulmonary edema | thoracic fluid content estimation using cardiometry and lung ultrasound | 30 minutes after start infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic fluid content, lung ultrasound, cesarean section, placenta accreta, colloid