Thoracic Fluid Content During Hypervolemic Hemodilution

NCT ID: NCT04689516

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-24
• Study Completion Date: 2022-01-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Thoracic fluid content estimation

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Thoracic fluid content estimation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

extravascular lung water estimation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Abdullah Mohamed

Lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University hospitals

Cairo, Manial, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 22593125 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10593797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22392031 (View on PubMed)

Other Identifiers

N- 25 / 2020

Identifier Type: -

Identifier Source: org_study_id