Thoracic Fluid Content During Hypervolemic Hemodilution

Not Applicable

Completed

• Conditions: Pulmonary Edema
• Interventions: Device: Thoracic fluid content estimation

• Registration Number: NCT04689516
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-24
• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-30
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Thoracic fluid content estimation	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.
The TFC Group	Thoracic fluid content estimation	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.

Primary Outcome Measures

Name	Time	Method
detection of pulmonary edema	30 minutes after start infusion	thoracic fluid content estimation using cardiometry and lung ultrasound

Trial Locations

Locations (1)

Cairo University hospitals; 🇪🇬 Cairo, Manial, Egypt