Thoracic Fluid Content During Hypervolemic Hemodilution

Pulmonary Edema Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689516
• Other study ID #: N- 25 / 2020
• Status: Completed
• Phase: N/A
• Start date: December 24, 2020
• Est. completion date: January 2, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta
• Pulmonary Edema

Intervention

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.

Locations

Country	Name	City	State
Egypt	Cairo University hospitals	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Kunst PW, Vonk Noordegraaf A, Raaijmakers E, Bakker J, Groeneveld AB, Postmus PE, de Vries PM. Electrical impedance tomography in the assessment of extravascular lung water in noncardiogenic acute respiratory failure. Chest. 1999 Dec;116(6):1695-702. — View Citation

Spahn DR, Theusinger OM, Hofmann A. Patient blood management is a win-win: a wake-up call. Br J Anaesth. 2012 Jun;108(6):889-92. doi: 10.1093/bja/aes166. — View Citation

Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of pulmonary edema	thoracic fluid content estimation using cardiometry and lung ultrasound	30 minutes after start infusion