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Thoracic Fluid Content During Hypervolemic Hemodilution

NCT04689516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-03-14

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Edema

Interventions

DEVICE

Thoracic fluid content estimation

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-24
Primary Completion
2021-12-30
Completion
2022-01-02

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04689516 on ClinicalTrials.gov