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NCT Number: NCT04689516

Thoracic Fluid Content During Hypervolemic Hemodilution

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University hospitals

Cairo, Manial, 12511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic fluid content estimation

Device

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.

Other names: extravascular lung water estimation

Primary outcomes

  1. detection of pulmonary edema

    Time frame: 30 minutes after start infusion

    thoracic fluid content estimation using cardiometry and lung ultrasound

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 30, 2020
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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