Thoracic Fluid Content During Hypervolemic Hemodilution

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04689516

Collaborator

(none)

Enrollment

Location

Arms

12.3

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Edema	Device: Thoracic fluid content estimation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official 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.

Actual Study Start Date :

Dec 24, 2020

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Jan 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Group 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 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
Experimental: The TFC Group 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 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

Arm

Intervention/Treatment

Experimental: Control Group

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

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

Experimental: The TFC Group

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

Other Names:

extravascular lung water estimation

Outcome Measures

Primary Outcome Measures

detection of pulmonary edema [30 minutes after start infusion]
thoracic fluid content estimation using cardiometry and lung ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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