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Thoracic Fluid Content During Hypervolemic Hemodilution

Primary Purpose

Pulmonary Edema

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic fluid content estimation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Edema focused on measuring Thoracic fluid content, lung ultrasound, cesarean section, placenta accreta, colloid

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo University hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Group

The TFC Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

detection of pulmonary edema
thoracic fluid content estimation using cardiometry and lung ultrasound

Secondary Outcome Measures

Full Information

First Posted
December 27, 2020
Last Updated
March 10, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04689516
Brief Title
Thoracic Fluid Content During Hypervolemic Hemodilution
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 24, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edema
Keywords
Thoracic fluid content, lung ultrasound, cesarean section, placenta accreta, colloid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
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.
Arm Title
The TFC Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Thoracic fluid content estimation
Other Intervention Name(s)
extravascular lung water estimation
Intervention Description
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.
Primary Outcome Measure Information:
Title
detection of pulmonary edema
Description
thoracic fluid content estimation using cardiometry and lung ultrasound
Time Frame
30 minutes after start infusion

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Cesarean section patients
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Cairo University hospitals
City
Cairo
State/Province
Manial
ZIP/Postal Code
12511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
not to share
Citations:
PubMed Identifier
22593125
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. No abstract available.
Results Reference
background
PubMed Identifier
10593797
Citation
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.
Results Reference
background
PubMed Identifier
22392031
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.
Results Reference
background

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Thoracic Fluid Content During Hypervolemic Hemodilution

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