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

Electrical Cardiometry VS Esophageal Doppler Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255550
• Other study ID #: Hemodynamic monitoring
• Status: Completed
• Start date: April 9, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 30, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Electrical Cardiometry VS Esophageal Doppler

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Egypt	Tarek Kaddah	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output measurement	Correlation between two devices regarding Cardiac Output measurement	24 hours Postoperative
Secondary	Cardiac Index	Assessment of other hemodynamic parameter Cardiac Index	Up to 24 hours
Secondary	Stroke Volume	Assessment of other hemodynamic parameter Stroke Volume	Up to 24 hours
Secondary	Stroke Volume Index	Assessment of other hemodynamic parameter Stroke Volume Index	Up to 24 hours
Secondary	Syetemic Vascular Resestance	Assessment of other hemodynamic parameter Syetemic Vascular Resestance	Up to 24 hours