Hemodynamic Monitoring and Correlation Between Electrical Cardiometry and Esophageal Doppler in Patients Undergoing Major Abdominal Surgery

NCT ID: NCT04255550

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-09

Study Completion Date

2020-12-30

Brief Summary

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The aim of this study is to correlate hemodynamic monitoring between noninvasive Electrical Cardiometry and minimally invasive Esophageal Doppler in patients undergoing major abdominal surgery

Detailed Description

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Cardiac output (CO) and Stroke Volume (SV) can be used as markers for global cardiovascular functions and can assess fluid responsiveness to ensure adequate tissue perfusion which is one of the essential concerns of anesthestists and intensivists The gold standard is the thermodilution procedure by pulmonary artery catheter (PAC), yet, cannot be considered as a routine owing to potential difficulty and virtual complications The development of safe, simple, minimally invasive or non-invasive techniques which estimate CO, SV and systemic vascular resistance (SVR) without invasive intravascular catheterization or dye injection is important for clinical decision-making and research in anesthesia and critical care medicine Echocardiography in comparison with other Doppler modalities is a potent diagnostic mean that has the superiority above the traditional PAC for both diagnostic precision and rapidity However, the use of echocardiography needs good training and relatively expensive. Another ultrasound based device is Esophageal Doppler(ED) which looks more suitable for prolonged hemodynamic monitoring. This technique is minimally invasive which calculates the blood flow velocity in descending aorta and can determine SV and CO with sound trustworthiness. Such technique needs less training than standard echocardiography or PAC Thoracic Electric Bioimpedance (TEB) is a noninvasive monitoring which correlates differences in thoracic electrical conductivity to thoracic aortic blood volume and flow. It is a simple method for detection of SV, CO, contractility, SVR, and thoracic fluid content (TFC) for continuous monitoring. The results of previous studies comparing impedance cardiography with thermo dilution and other methods like transoesophageal echocardiography (TEE) have been largely inconclusive which may referred to higher thorax fluid content and consequently higher conductivity after surgical procedure To overcome these problems, upgraded computer equipment and advanced algorithms are used in the newer model; electrical cardiometry (EC), that interprets the maximum changes in TEB and can calculate CO accurately in adults and neonates Although other study compared between two devices in patients undergoing major abdominal and pelvic surgeries , but the sample size was small rather than our study , also it included laparoscopic surgeries which affect hemodynamics (blood pressure , heart rate and other cardiac parameters ) in such points . In addition investigators used the old version of thoracic bio-impedance (NICOM) which is different from our device as we will us (ICON) , Like another study comparing between two devices used also the old version of thoracic bio-impedance and didn't specify the type of surgery at which the study was done . There are also other studies comparing the two devices one of them in paediatrics undergoing kasai operation and the second in patients during liver transplantation , these two studies contain two types of patients not included in the present study .

Conditions

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Electrical Cardiometry VS Esophageal Doppler

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Esophageal doppler

It is a prospective observational clinical study to correlate hemodynamic monitoring between non-invasive Electrical Cardiometry and minimally invasive Esophageal Doppler during major abdominal surgery.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Electrical cardiometry

Eligibility Criteria

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Inclusion Criteria

* Geriatric patients.
* American Society of Anesthesiologists (ASA) physical status II or III.
* Patients listed for elective major abdominal surgery such as (e.g. cancer stomach, colon, bladder, or pancreas).

Exclusion Criteria

* Age \<50 years.
* Patients with hemodynamic instability and on inotropes which means ( perfusion failure, represented by clinical features of circulatory shock and advanced heart failure , It may also be defined as 1 or more out-of-range vital sign measurements, such as low blood pressure).
* Coagulopathies (platelet \< 100×109/L, PT \> 16 s and INR \> 1.2).
* History of esophageal pathology.
* Patient needed massive blood transfusion intraoperatively which means replacement of \>1 blood volume in 24 hours or \>50% of blood volume in 4 hours (adult blood volume is approximately 70 mL/kg).
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Theodor Bilharz Research Institute

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek Kaddah, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Abla Elhadedy, M.D

Role: PRINCIPAL_INVESTIGATOR

Theodor Bilharz Institute

Shady Rady Abdalla, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Ahmed salah abdelazeem elsayed, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Theodor Bilharz Institute

Ahmed Abdalla Mohamed, M.D

Role: STUDY_CHAIR

Cairo University

Hanan Khafagy, M.D

Role: STUDY_DIRECTOR

Theodor Bilharz Institute

Reham Saeed, M.D

Role: STUDY_DIRECTOR

Theodor Bilharz Institute

Haitham Abouzeid, M.D

Role: STUDY_DIRECTOR

Theodor Bilharz Institute

Ahmed Essam, M.D

Role: STUDY_DIRECTOR

Theodor Bilharz Institute

Locations

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Tarek Kaddah

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Hemodynamic monitoring

Identifier Type: -

Identifier Source: org_study_id

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