CompletedNot Applicable

Thoracic Fluid Content During Hypervolemic Hemodilution

Egypt56 participantsStarted 2020-12-24

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

detection of pulmonary edema

Timeframe: 30 minutes after start infusion

Trial details

NCT IDNCT04689516

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-30

View on ClinicalTrials.gov More Pulmonary Edema trials