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Thoracic Fluid Content During Hypervolemic Hemodilution

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04689516
Enrollment
56
Registered
2020-12-30
Start date
2020-12-24
Completion date
2022-01-02
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Edema

Keywords

Thoracic fluid content, lung ultrasound, cesarean section, placenta accreta, colloid

Brief 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.

Interventions

DEVICEThoracic 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

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
detection of pulmonary edema30 minutes after start infusionthoracic fluid content estimation using cardiometry and lung ultrasound

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026