Thoracic Fluid Content During Hypervolemic Hemodilution

NCT04689516 | Completed

• 1 other identifier: N- 25 / 2020
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Edema

Keywords

Thoracic fluid content; lung ultrasound; cesarean section; placenta accreta; colloid

Outcome Measures

Primary Outcomes (1)

• detection of pulmonary edema

  thoracic fluid content estimation using cardiometry and lung ultrasound

  30 minutes after start infusion

Study Arms (2)

Control Group

EXPERIMENTAL

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 TFC Group

EXPERIMENTAL

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

Interventions

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.

Also known as: extravascular lung water estimation

Control Group; The TFC Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Cesarean section patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• years old
• ASA I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University hospitals

Cairo, Manial, 12511, Egypt

Location

Related Publications (3)

• 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. No abstract available.

  PMID: 22593125 BACKGROUND

• 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. doi: 10.1378/chest.116.6.1695.

  PMID: 10593797 BACKGROUND

• 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.

  PMID: 22392031 BACKGROUND

MeSH Terms

Conditions

Pulmonary Edema; Placenta Accreta

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: December 24, 2020
• Primary Completion: December 30, 2021
• Study Completion: January 2, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)